A Phase 2 interventional study of Induction- PF-06480605 50 mg SC Q4W and Induction- PF-06480605 150 mg SC Q4W in Moderate to Severe Ulcerative Colitis, sponsored by Hoffmann-La Roche. Completed at 166 sites in 23 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W
Other: Induction- Placebo SC Q4W · Drug: Chronic- PF-06480605 50 mg SC Q4W
Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Other: Induction- Placebo SC Q4W · Drug: Chronic- PF-06480605 150 mg SC Q4W
Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Other: Induction- Placebo SC Q4W · Drug: Chronic- PF-06480605 450 mg SC Q4W
Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Drug: Induction- PF-06480605 50 mg SC Q4W · Drug: Chronic- PF-06480605 50 mg SC Q4W
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Drug: Induction- PF-06480605 150 mg SC Q4W · Drug: Chronic- PF-06480605 50 mg SC Q4W
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Drug: Induction- PF-06480605 150 mg SC Q4W · Drug: Chronic- PF-06480605 150 mg SC Q4W
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Drug: Induction- PF-06480605 450 mg SC Q4W · Drug: Chronic- PF-06480605 50 mg SC Q4W
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Drug: Induction- PF-06480605 450 mg SC Q4W · Drug: Chronic- PF-06480605 150 mg SC Q4W
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Drug: Induction- PF-06480605 450 mg SC Q4W · Drug: Chronic- PF-06480605 450 mg SC Q4W
PF-06480605
PF-06480605
PF-06480605
0 mg Placebo
PF-06480605
PF-06480605
PF-06480605
Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: At Week 14
Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Time frame: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Induction Period: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Time frame: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Time frame: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Chronic Period: Number of Participants With TEAEs
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Time frame: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Chronic Period: Number of Participants With SAEs
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Time frame: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Time frame: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chrnoic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605
Time frame: Induction Period: 30 mins postdose on Day 1, Weeks 4, 8, 12 and 14; Chronic Period: 30 mins postdose on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (Week 52) and Follow-up (FU) Visits 1 (Week 56), 2 (Week 60) and 3 (Week 64)
Induction Period: Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Weeks 4, 8, and 12
Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, Weeks 4, 8, and 12
Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)
Time frame: Baseline, Weeks 4, 8, and 12
Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5.
Time frame: Baseline, Weeks 4, 8, 12, 14
Chronic Period: Percentage of Participants Who Achieved Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: At Week 56
Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Chronic Period: Change From Week 16 in Fecal Calprotectin
Time frame: Week 16 (baseline), Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64
Chronic Period: Change From Week 14 in hsCRP
Time frame: Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Chronic Period: Change From Week 14 in Serum sTL1A
Time frame: Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Change From Baseline in Fecal Calprotectin Through the End of Study
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64
Change From Baseline in hsCRP Through the End of Study
Time frame: Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Change From Baseline in Serum sTL1A Through the End of Study
Time frame: Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Chronic Period: Number of Participants With ADA and NAbs to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5.
Time frame: Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
A total of 246 participants with moderate to severe ulcerative colitis (UC) took part in the study at 114 investigative sites across 23 countries from 19 December 2019 to 25 October 2022. The study consisted of a 12-week induction period and a 40-week chronic therapy period.
| Milestone | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 45 | 47 | 62 | 92 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 40 | 46 | 58 | 84 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 5 | 1 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 3 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 1 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 12 | 14 | 14 | 46 | 27 | 30 | 26 | 26 | 29 |
| Completed | 0 | 0 | 0 | 0 | 11 | 12 | 12 | 34 | 22 | 25 | 18 | 20 | 24 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 12 | 5 | 5 | 8 | 6 | 5 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 | 0 | 5 | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 2 | 2 | 2 | 1 | 2 |
| Withdrew: Relocation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 3 | 3 | 3 | 1 | 3 | 0 |
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|---|
| Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 | 11.6 (5.77 to 22.88) | 25.5 (15.44 to 37.19) | 23.3 (14.98 to 33.98) | 23.9 (16.58 to 32.06) |
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
| Participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|---|
| Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 25 | 16 | 29 | 49 |
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
| Participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|---|
| Induction Period: Number of Participants With Serious Adverse Events (SAEs) | 4 | 3 | 1 | 4 |
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
| Participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|---|
| Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 | 0 | 0 | 0 |
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
| Participants | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Chronic Period: Number of Participants With TEAEs | 5 | 9 | 9 | 30 | 16 | 15 | 18 | 18 | 20 |
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
| Participants | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Chronic Period: Number of Participants With SAEs | 0 | 0 | 0 | 5 | 1 | 0 | 2 | 1 | 4 |
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
| Participants | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 7.0 (2.59 to 16.96) | 14.9 (8.05 to 25.12) | 13.3 (6.81 to 21.83) | 14.8 (9.50 to 21.77) | 16.7 (4.52 to 39.84) | 23.1 (8.80 to 46.97) | 21.4 (8.15 to 46.00) | 16.7 (9.06 to 27.68) | 22.2 (10.15 to 38.16) | 23.1 (10.56 to 39.84) | 16.0 (7.17 to 30.73) | 20.8 (10.50 to 36.99) | 17.9 (8.95 to 33.31) |
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 11.6 (5.77 to 22.88) | 29.8 (19.94 to 42.34) | 35.0 (25.14 to 45.24) | 31.8 (23.65 to 40.77) | 50.0 (27.13 to 72.87) | 30.8 (14.16 to 54.45) | 35.7 (16.30 to 59.44) | 31.0 (19.38 to 43.33) | 33.3 (20.38 to 50.00) | 38.5 (23.32 to 56.43) | 28.0 (15.76 to 45.61) | 33.3 (17.80 to 52.14) | 35.7 (20.85 to 52.70) |
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 18.6 (9.61 to 30.24) | 40.4 (28.33 to 53.46) | 38.3 (27.81 to 48.61) | 40.9 (32.06 to 50.00) | 66.7 (39.84 to 84.58) | 38.5 (17.28 to 62.14) | 42.9 (22.38 to 64.51) | 38.1 (25.56 to 51.95) | 37.0 (22.12 to 54.66) | 39.3 (23.83 to 56.49) | 36.0 (21.43 to 54.39) | 37.5 (22.08 to 55.27) | 50.0 (33.31 to 66.69) |
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 7.0 (2.59 to 16.96) | 19.1 (11.18 to 30.27) | 10.0 (4.45 to 18.01) | 10.2 (5.72 to 16.58) | 16.7 (4.52 to 39.84) | 23.1 (8.80 to 46.97) | 28.6 (13.09 to 54.00) | 11.9 (5.91 to 22.74) | 7.4 (1.99 to 20.38) | 7.1 (1.92 to 20.10) | 16.0 (7.17 to 30.73) | 8.3 (2.24 to 22.08) | 21.4 (9.77 to 36.62) |
| nanograms per milliliter (ng/mL) | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Postdose on Day 1 | NA ± NA | 1.227 ± 6.7722 | 1.279 ± 10.209 | — | — | — | — | — | — | — | — | — |
| Postdose on Week 4 | 2251 ± 1122.5 | 6568 ± 3043.4 | 19660 ± 8637.7 | — | — | — | — | — | — | — | — | — |
| Postdose on Week 8 | 2232 ± 1858.5 | 8381 ± 4769.8 | 25160 ± 12194 | — | — | — | — | — | — | — | — | — |
| Postdose on Week 12 | 2181 ± 2080.3 | 8914 ± 5425.9 | 30900 ± 15724 | — | — | — | — | — | — | — | — | — |
| Postdose on Week 14 | 4198 ± 3252.9 | 17110 ± 9380.6 | 49480 ± 18086 | — | — | — | — | — | — | — | — | — |
| Postdose on Week 16 | — | — | — | NA ± NA | 240.4 ± 862.23 | 6.123 ± 22.077 | 1969 ± 1932.7 | 9613 ± 6568.8 | 12450 ± 7605.4 | 39180 ± 19045 | 36320 ± 18215 | 32450 ± 17064 |
| Postdose on Week 20 | — | — | — | 2924 ± 1706.7 | 6680 ± 4188.0 | 25030 ± 9240.1 | 2516 ± 2279.8 | 5476 ± 4062.3 | 11500 ± 6289.0 | 19540 ± 10180 | 18200 ± 12244 | 34980 ± 17895 |
| Postdose on Week 24 | — | — | — | 2897 ± 1494.1 | 10990 ± 8884.5 | 29820 ± 15940 | 2956 ± 3018.7 | 4811 ± 3089.1 | 11090 ± 6765.1 | 10040 ± 6001.7 | 16890 ± 13735 | 35110 ± 16669 |
| Postdose on Week 28 | — | — | — | 2915 ± 2739.1 | 7587 ± 4748.7 | 38270 ± 12846 | 2613 ± 2763.5 | 3391 ± 2267.9 | 9840 ± 6630.1 | 5894 ± 3973.7 | 12920 ± 8418.9 | 35080 ± 14331 |
| Postdose on Week 32 | — | — | — | 2672 ± 2275.6 | 10520 ± 8027.4 | 38950 ± 21386 | 2330 ± 2253.4 | 3608 ± 3088.1 | 11790 ± 5931.7 | 5465 ± 3299.1 | 12060 ± 8871.1 | 36720 ± 16880 |
| Postdose on Week 36 | — | — | — | 3478 ± 2422.7 | 9279 ± 8345.1 | 36520 ± 20234 | 2802 ± 2573.3 | 3417 ± 2301.7 | 11680 ± 6728.9 | 4610 ± 2651.5 | 12360 ± 7217.1 | 33660 ± 14185 |
| Postdose on Week 40 | — | — | — | 2793 ± 1893.0 | 9246 ± 6289.2 | 41770 ± 18436 | 2820 ± 2590.1 | 3374 ± 2922.0 | 12050 ± 7678.1 | 3900 ± 2874.5 | 11830 ± 7571.4 | 33660 ± 11189 |
| Postdose on Week 44 | — | — | — | 3314 ± 2152.2 | 9346 ± 5199.5 | 45770 ± 20693 | 2867 ± 2655.4 | 3385 ± 3540.7 | 12190 ± 6504.8 | 3708 ± 2471.4 | 13060 ± 8745.9 | 36450 ± 12884 |
| Postdose on Week 48 | — | — | — | 2921 ± 2084.1 | 10750 ± 8216.0 | 46150 ± 19825 | 3159 ± 2810.1 | 3876 ± 3276.1 | 13230 ± 7740.3 | 4494 ± 3860.2 | 13700 ± 10253 | 38310 ± 13146 |
| EOT (Week 52) | — | — | — | 3532 ± 2447.9 | 10510 ± 10337 | 49880 ± 21069 | 2848 ± 3037.0 | 3156 ± 2337.1 | 14580 ± 7988.8 | 4215 ± 3708.6 | 13930 ± 8673.4 | 40710 ± 15146 |
| FU Visit 1 (Week 56) | — | — | — | 4152 ± 3804.3 | 9755 ± 6903.0 | 43710 ± 26683 | 3246 ± 2965.2 | 3124 ± 2443.2 | 12870 ± 7884.4 | 4036 ± 3398.6 | 13410 ± 9499.7 | 43290 ± 17036 |
| FU Visit 2 (Week 60) | — | — | — | 1550 ± 1580.2 | 3797 ± 4065.6 | 19390 ± 13334 | 1092 ± 1232.9 | 1025 ± 858.32 | 4806 ± 2827.2 | 1285 ± 1436.1 | 5266 ± 5457.1 | 13930 ± 9036.0 |
| FU Visit 3 (Week 64) | — | — | — | 1099 ± 2081.3 | 1332 ± 2390.4 | 7976 ± 5279.5 | 766.1 ± 2372.9 | 257.3 ± 318.70 | 2011 ± 1752.1 | 825.8 ± 1883.2 | 1840 ± 2045.6 | 7136 ± 5642.6 |
| micrograms per gram (µg/g) | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|---|
| Baseline | 10.62 ± 2.145 | 9.99 ± 2.105 | 10.78 ± 2.120 | 10.23 ± 1.618 |
| Change From Baseline at Week 4 | -0.32 ± 2.294 | -0.38 ± 1.973 | -1.24 ± 2.429 | -0.86 ± 2.618 |
| Change From Baseline at Week 8 | -0.77 ± 2.601 | -1.28 ± 2.620 | -1.84 ± 2.779 | -1.69 ± 2.991 |
| Change From Baseline at Week 12 | -0.62 ± 3.208 | -1.36 ± 2.837 | -2.43 ± 2.859 | -1.44 ± 3.003 |
| log2-transformed milligrams/liter (mg/L) | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|---|
| Baseline | 1.76 ± 2.135 | 1.47 ± 1.990 | 1.41 ± 1.799 | 1.82 ± 1.924 |
| Change From Baseline at Week 4 | -0.49 ± 1.503 | -0.48 ± 1.669 | -0.75 ± 1.762 | -1.08 ± 1.577 |
| Change From Baseline at Week 8 | -0.49 ± 1.929 | -0.45 ± 1.896 | -0.94 ± 2.120 | -1.09 ± 1.697 |
| Change From Baseline at Week 12 | -0.96 ± 2.305 | -0.71 ± 1.764 | -1.25 ± 1.748 | -1.06 ± 1.834 |
| picograms per milliliter (pg/mL) | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|---|
| Baseline | 6.86 ± 0.441 | 6.74 ± 0.499 | 6.77 ± 0.534 | 6.83 ± 0.558 |
| Change From Baseline at Week 4 | 0.01 ± 0.347 | 3.45 ± 1.097 | 3.85 ± 1.294 | 4.91 ± 0.834 |
| Change From Baseline at Week 8 | -0.05 ± 0.549 | 3.14 ± 1.340 | 3.80 ± 1.486 | 4.88 ± 1.294 |
| Change From Baseline at Week 12 | -0.02 ± 0.371 | 2.86 ± 1.666 | 3.72 ± 1.530 | 4.71 ± 1.908 |
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5.
| Participants | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg |
|---|---|---|---|
| ADA at Baseline | 0 | 1 | 2 |
| NAb at Baseline | — | 0 | 0 |
| ADA at Week 4 | 29 | 16 | 24 |
| NAb at Week 4 | 1 | 0 | 0 |
| ADA at Week 8 | 39 | 34 | 34 |
| NAb at Week 8 | 10 | 4 | 1 |
| ADA at Week 12 | 41 | 36 | 36 |
| NAb at Week 12 | 12 | 7 | 3 |
| ADA at Week 14 | 41 | 35 | 33 |
| NAb at Week 14 | 14 | 7 | 3 |
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 33.3 (15.42 to 60.16) | 38.5 (17.28 to 62.14) | 35.7 (16.30 to 59.44) | 31.0 (19.38 to 43.33) | 29.6 (15.68 to 45.34) | 34.6 (20.86 to 52.62) | 24.0 (11.01 to 41.68) | 25.0 (11.49 to 42.28) | 39.3 (23.83 to 56.49) |
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|
| Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 0 (0 to 0) | 25.0 (2.60 to 67.95) | 50.0 (27.13 to 72.87) | 50.0 (20.09 to 79.91) | 62.5 (28.92 to 85.31) | 28.6 (7.88 to 65.87) | 50.0 (20.09 to 79.91) | 85.7 (50.00 to 98.51) |
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|
| Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 33.3 (3.45 to 80.42) | 28.6 (7.88 to 65.87) | 40.0 (11.22 to 75.34) | 66.7 (19.58 to 96.55) | 25.0 (2.60 to 67.95) | 0 (0 to 53.58) | 80.0 (37.93 to 97.91) |
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 0 (0.00 to 90.00) | 0 (0.00 to 90.00) | 33.3 (3.45 to 80.42) | 42.9 (22.38 to 64.51) | 70.0 (39.34 to 88.42) | 54.5 (30.24 to 80.04) | 33.3 (12.95 to 61.04) | 60.0 (34.08 to 81.24) | 75.0 (41.82 to 93.14) |
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 50.0 (5.13 to 94.87) | 0 (0.00 to 68.38) | 25.0 (2.60 to 67.95) | 47.4 (27.39 to 66.28) | 80.0 (50.00 to 94.55) | 61.5 (37.86 to 82.72) | 46.2 (24.55 to 71.30) | 63.6 (34.98 to 83.08) | 80.0 (50.00 to 94.55) |
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|
| Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 0 (0.00 to 68.38) | 0 (0.00 to 90.00) | 22.2 (6.08 to 51.52) | 50.0 (5.13 to 94.87) | 25.0 (2.60 to 67.95) | 66.7 (19.58 to 96.55) | 50.0 (5.13 to 94.87) | 66.7 (19.58 to 96.55) |
| μg/g | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Week 16 | 10.22 ± 1.414 | 9.28 ± 2.578 | 9.77 ± 2.347 | 8.86 ± 2.728 | 9.03 ± 2.765 | 7.72 ± 2.642 | 9.34 ± 2.500 | 8.39 ± 2.368 | 9.21 ± 2.438 |
| Change From Week 16 at Week 20 | -0.40 ± 1.174 | -1.46 ± 2.251 | -1.32 ± 1.956 | -0.31 ± 2.114 | 0.26 ± 2.247 | 0.43 ± 1.403 | -0.32 ± 1.740 | 0.18 ± 2.569 | -0.46 ± 1.435 |
| Change From Week 16 at Week 24 | -0.71 ± 1.302 | -0.84 ± 1.718 | -1.47 ± 3.331 | 0.24 ± 2.242 | -0.15 ± 2.433 | 0.36 ± 2.638 | -0.16 ± 1.874 | -0.30 ± 1.619 | 0.10 ± 1.892 |
| Change From Week 16 at Week 28 | -1.55 ± 1.984 | -1.17 ± 3.018 | -1.48 ± 1.817 | -0.16 ± 2.928 | -0.15 ± 2.409 | 0.03 ± 1.996 | -0.32 ± 2.440 | -0.16 ± 1.716 | -0.53 ± 2.136 |
| Change From Week 16 at Week 32 | -0.91 ± 2.497 | -1.36 ± 3.553 | -2.47 ± 3.044 | 0.21 ± 2.321 | -0.32 ± 2.516 | 0.31 ± 2.453 | -0.13 ± 2.192 | 0.17 ± 2.102 | -0.08 ± 1.491 |
| Change From Week 16 at Week 36 | -0.68 ± 2.353 | -1.83 ± 2.542 | -2.36 ± 4.202 | -0.37 ± 2.465 | -0.21 ± 2.584 | 0.50 ± 2.152 | -0.67 ± 1.889 | -0.36 ± 2.362 | -0.32 ± 1.724 |
| Change From Week 16 at Week 40 | -1.62 ± 1.814 | 0.22 ± 3.962 | -2.59 ± 2.493 | 0.17 ± 2.604 | 0.02 ± 1.779 | 0.35 ± 2.179 | 0.01 ± 2.696 | -0.42 ± 1.672 | -0.62 ± 2.434 |
| Change From Week 16 at Week 44 | -0.68 ± 2.015 | -1.48 ± 2.693 | -1.81 ± 2.705 | -0.09 ± 2.023 | -0.98 ± 2.089 | 0.02 ± 2.568 | 0.21 ± 2.377 | -0.97 ± 1.890 | -0.69 ± 1.737 |
| Change From Week 16 at Week 48 | -0.85 ± 1.843 | -1.01 ± 3.642 | -2.56 ± 3.178 | 0.60 ± 2.255 | -0.78 ± 2.542 | 0.09 ± 3.320 | 0.03 ± 3.027 | -0.54 ± 2.248 | -0.47 ± 2.150 |
| Change From Week 16 at Week 52 | -1.39 ± 1.922 | -0.39 ± 3.222 | -2.84 ± 2.668 | -0.02 ± 2.327 | -0.12 ± 1.386 | 0.09 ± 2.558 | -0.20 ± 3.294 | -0.61 ± 2.259 | -0.75 ± 2.355 |
| Change From Week 16 at Week 60 | -1.31 ± 2.119 | -0.09 ± 1.780 | -1.96 ± 3.041 | 0.36 ± 3.169 | -0.60 ± 1.840 | 0.17 ± 2.939 | 1.61 ± 1.426 | -0.91 ± 2.915 | -0.95 ± 2.131 |
| Change From Week 16 at Week 64 | -0.54 ± 2.208 | -1.48 ± 2.426 | -0.86 ± 2.562 | 0.58 ± 2.705 | 0.29 ± 1.834 | 0.10 ± 3.982 | 0.85 ± 3.321 | -1.18 ± 4.080 | -0.82 ± 2.007 |
| log2-transformed mg/L | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Week 14 | 1.22 ± 1.667 | 2.49 ± 2.149 | 0.43 ± 2.484 | 0.72 ± 2.322 | 0.26 ± 1.898 | 0.11 ± 1.724 | 0.49 ± 2.152 | 0.56 ± 1.843 | 1.55 ± 1.376 |
| Change From Week 14 at Week 16 | -0.17 ± 0.745 | -0.32 ± 1.057 | -0.05 ± 1.622 | 0.12 ± 0.895 | 0.28 ± 1.218 | 0.04 ± 1.074 | -0.18 ± 1.247 | -0.21 ± 1.390 | -0.12 ± 1.283 |
| Change From Week 14 at Week 20 | -0.41 ± 1.420 | -1.06 ± 1.370 | -0.48 ± 2.403 | 0.34 ± 1.390 | 0.32 ± 1.449 | 0.48 ± 1.736 | -0.22 ± 1.141 | 0.68 ± 2.359 | -0.19 ± 1.362 |
| Change From Week 14 at Week 24 | -0.76 ± 1.232 | -1.52 ± 1.440 | -1.01 ± 2.445 | 0.28 ± 1.328 | 0.23 ± 1.063 | 0.06 ± 0.882 | -0.20 ± 1.391 | -0.13 ± 1.372 | -0.16 ± 1.387 |
| Change From Week 14 at Week 28 | -1.01 ± 1.398 | -1.12 ± 1.917 | -0.36 ± 1.665 | 0.31 ± 1.362 | 0.29 ± 1.156 | 0.26 ± 1.050 | -0.28 ± 1.546 | -0.25 ± 1.347 | -0.23 ± 1.044 |
| Change From Week 14 at Week 32 | -0.32 ± 1.893 | -0.79 ± 1.535 | -0.85 ± 2.253 | 0.30 ± 1.720 | 0.32 ± 1.565 | 0.72 ± 1.347 | -0.56 ± 1.572 | 0.28 ± 1.474 | -0.29 ± 1.347 |
| Change From Week 14 at Week 36 | -1.04 ± 2.335 | -1.29 ± 1.786 | -0.67 ± 2.760 | 0.07 ± 1.430 | 0.29 ± 1.490 | 0.28 ± 1.179 | -0.43 ± 1.507 | 0.36 ± 2.013 | -0.24 ± 1.614 |
| Change From Week 14 at Week 40 | -0.50 ± 1.893 | -1.09 ± 1.827 | -1.56 ± 2.351 | 0.17 ± 1.596 | 0.16 ± 1.432 | 0.31 ± 1.206 | -0.35 ± 1.645 | 0.19 ± 1.252 | -0.66 ± 1.154 |
| Change From Week 14 at Week 44 | -0.11 ± 1.709 | -1.31 ± 1.707 | -1.28 ± 2.448 | -0.06 ± 1.589 | -0.15 ± 1.612 | 0.66 ± 1.083 | 0.05 ± 1.513 | 0.20 ± 1.457 | -0.75 ± 1.272 |
| Change From Week 14 at Week 48 | -0.59 ± 1.596 | -1.29 ± 1.700 | -1.23 ± 2.619 | 0.28 ± 1.749 | 0.31 ± 1.314 | 0.21 ± 1.213 | 0.07 ± 0.985 | 0.07 ± 1.674 | -0.53 ± 1.254 |
| Change From Week 14 at Week 52 | -0.01 ± 2.228 | -1.05 ± 1.726 | -1.59 ± 2.195 | 0.10 ± 1.248 | 0.09 ± 1.299 | -0.13 ± 0.985 | 0.43 ± 1.144 | -0.02 ± 1.760 | -0.63 ± 1.221 |
| Change From Week 14 at Week 56 | -0.28 ± 1.346 | -0.92 ± 1.776 | -0.57 ± 1.766 | 0.25 ± 1.525 | 0.17 ± 1.998 | 0.21 ± 1.129 | 0.65 ± 0.994 | 0.31 ± 1.801 | -0.34 ± 1.463 |
| Change From Week 14 at Week 60 | -0.50 ± 2.114 | -0.93 ± 1.857 | -0.63 ± 2.397 | 0.40 ± 1.804 | 1.21 ± 1.844 | 0.51 ± 0.992 | 0.14 ± 1.395 | -0.55 ± 1.390 | -0.91 ± 1.643 |
| Change From Week 14 at Week 64 | 0.35 ± 1.750 | -0.97 ± 2.090 | -1.12 ± 2.366 | 0.28 ± 1.633 | 0.33 ± 1.848 | 0.22 ± 1.699 | 0.52 ± 1.659 | -0.06 ± 2.231 | -0.64 ± 1.802 |
| pg/mL | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Week 14 | 6.84 ± 0.443 | 7.21 ± 1.254 | 6.67 ± 0.463 | 9.78 ± 1.421 | 10.71 ± 1.543 | 10.61 ± 1.488 | 11.30 ± 2.495 | 11.34 ± 1.752 | 11.83 ± 0.726 |
| Change From Week 14 at Week 16 | -0.13 ± 0.576 | 0.29 ± 0.328 | 0.12 ± 0.330 | -0.03 ± 0.431 | -0.16 ± 0.302 | 0.03 ± 0.494 | 0.00 ± 0.987 | -0.26 ± 0.510 | -0.35 ± 0.435 |
| Change From Week 14 at Week 20 | 3.97 ± 0.722 | 3.43 ± 1.840 | 5.42 ± 0.954 | -0.03 ± 0.675 | -0.36 ± 0.645 | -0.01 ± 0.762 | -0.22 ± 1.086 | -0.74 ± 0.638 | -0.61 ± 0.780 |
| Change From Week 14 at Week 24 | 2.85 ± 1.141 | 3.84 ± 1.872 | 5.65 ± 0.909 | -0.02 ± 0.999 | -0.59 ± 0.912 | -0.41 ± 1.518 | -0.60 ± 1.133 | -0.90 ± 0.831 | -0.70 ± 1.047 |
| Change From Week 14 at Week 28 | 2.96 ± 1.033 | 3.78 ± 1.759 | 5.88 ± 0.731 | -0.16 ± 1.032 | -0.69 ± 1.036 | -0.33 ± 1.531 | -0.78 ± 1.384 | -0.87 ± 1.017 | -0.65 ± 1.047 |
| Change From Week 14 at Week 32 | 3.18 ± 1.346 | 3.65 ± 1.749 | 5.87 ± 0.588 | -0.10 ± 1.158 | -0.73 ± 1.092 | -0.07 ± 0.857 | -1.08 ± 1.337 | -0.93 ± 0.935 | -0.67 ± 0.914 |
| Change From Week 14 at Week 36 | 3.35 ± 1.185 | 3.53 ± 1.811 | 5.77 ± 0.745 | 0.06 ± 1.285 | -0.80 ± 1.036 | 0.01 ± 0.743 | -1.28 ± 1.630 | -0.81 ± 0.992 | -0.60 ± 0.812 |
| Change From Week 14 at Week 40 | 3.45 ± 0.990 | 3.17 ± 1.909 | 5.66 ± 0.926 | 0.04 ± 1.243 | -0.95 ± 1.188 | -0.01 ± 0.919 | -1.32 ± 1.739 | -0.75 ± 1.017 | -0.67 ± 0.891 |
| Change From Week 14 at Week 44 | 3.41 ± 1.068 | 3.09 ± 1.640 | 5.58 ± 1.106 | -0.01 ± 1.289 | -0.83 ± 1.282 | -0.11 ± 0.634 | -1.35 ± 1.812 | -0.60 ± 0.958 | -0.59 ± 0.873 |
| Change From Week 14 at Week 48 | 3.36 ± 1.108 | 2.83 ± 1.601 | 5.73 ± 1.029 | 0.03 ± 1.138 | -0.79 ± 1.198 | 0.14 ± 0.779 | -1.25 ± 1.554 | -0.54 ± 1.145 | -0.47 ± 0.853 |
| Change From Week 14 at Week 52 | 3.59 ± 1.128 | 2.83 ± 1.875 | 5.74 ± 1.224 | 0.06 ± 1.119 | -0.65 ± 1.090 | 0.26 ± 0.675 | -1.49 ± 1.711 | -0.54 ± 1.031 | -0.55 ± 1.134 |
| Change From Week 14 at Week 56 | 3.72 ± 1.114 | 2.71 ± 1.999 | 5.69 ± 1.173 | 0.31 ± 1.155 | -0.57 ± 1.191 | 0.26 ± 0.976 | -1.36 ± 1.870 | -0.29 ± 0.990 | -0.33 ± 0.919 |
| Change From Week 14 at Week 60 | 2.95 ± 1.646 | 2.87 ± 1.505 | 5.37 ± 1.556 | -0.08 ± 1.557 | -0.60 ± 1.303 | -0.13 ± 0.924 | -1.55 ± 1.985 | -0.70 ± 1.583 | -0.64 ± 0.929 |
| Change From Week 14 at Week 64 | 3.15 ± 1.775 | 2.88 ± 1.730 | 4.83 ± 1.860 | -0.28 ± 1.391 | -0.68 ± 1.200 | -0.19 ± 0.823 | -1.45 ± 2.361 | -0.97 ± 1.697 | -0.75 ± 1.062 |
| μg/g | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 10.43 ± 1.530 | 11.06 ± 1.450 | 10.44 ± 2.984 | 9.91 ± 2.069 | 11.12 ± 1.472 | 10.38 ± 2.683 | 10.41 ± 1.218 | 9.95 ± 2.225 | 10.23 ± 1.446 |
| Change From Baseline at Week 4 | 0.41 ± 2.745 | -0.21 ± 0.925 | -1.15 ± 2.572 | -0.38 ± 1.973 | -1.56 ± 1.722 | -1.03 ± 3.037 | -1.28 ± 3.038 | -0.80 ± 2.727 | -0.69 ± 2.513 |
| Change From Baseline at Week 8 | -0.36 ± 1.169 | -0.56 ± 1.601 | -1.21 ± 3.752 | -1.27 ± 2.652 | -2.03 ± 2.251 | -1.69 ± 3.357 | -2.29 ± 3.142 | -1.76 ± 3.108 | -1.27 ± 2.874 |
| Change From Baseline at Week 12 | 0.46 ± 2.788 | -0.84 ± 2.026 | -1.32 ± 4.008 | -1.36 ± 2.837 | -2.62 ± 2.563 | -2.42 ± 3.174 | -1.21 ± 3.159 | -1.75 ± 3.477 | -1.31 ± 2.634 |
| Change From Baseline at Week 16 | -0.21 ± 1.742 | -1.73 ± 2.941 | -0.67 ± 3.908 | -1.48 ± 3.378 | -2.30 ± 2.662 | -2.55 ± 2.883 | -0.87 ± 3.039 | -1.26 ± 3.043 | -1.08 ± 2.368 |
| Change From Baseline at Week 20 | -0.61 ± 2.247 | -2.48 ± 2.935 | -2.35 ± 3.701 | -1.71 ± 3.104 | -1.87 ± 2.328 | -2.10 ± 2.824 | -1.61 ± 3.685 | -1.70 ± 3.353 | -1.55 ± 2.490 |
| Change From Baseline at Week 24 | -0.92 ± 2.115 | -1.68 ± 2.505 | -2.52 ± 3.263 | -1.00 ± 3.050 | -2.31 ± 2.910 | -2.29 ± 3.768 | -1.25 ± 2.899 | -1.52 ± 3.478 | -0.95 ± 2.877 |
| Change From Baseline at Week 28 | -1.76 ± 2.456 | -3.08 ± 3.021 | -2.70 ± 2.246 | -1.31 ± 3.225 | -2.46 ± 2.750 | -2.85 ± 3.782 | -1.60 ± 3.431 | -1.58 ± 3.213 | -1.61 ± 2.428 |
| Change From Baseline at Week 32 | -1.43 ± 2.920 | -2.45 ± 2.916 | -2.87 ± 2.951 | -1.19 ± 3.384 | -2.62 ± 2.906 | -2.61 ± 3.609 | -1.56 ± 3.253 | -1.48 ± 3.014 | -1.31 ± 2.032 |
| Change From Baseline at Week 36 | -1.05 ± 2.958 | -3.14 ± 2.233 | -3.11 ± 3.401 | -1.80 ± 3.019 | -2.39 ± 2.680 | -2.31 ± 3.468 | -2.11 ± 3.406 | -2.08 ± 3.070 | -2.05 ± 2.502 |
| Change From Baseline at Week40 | -1.99 ± 2.555 | -1.30 ± 2.745 | -3.02 ± 2.912 | -1.35 ± 3.354 | -2.17 ± 2.130 | -2.24 ± 3.311 | -1.58 ± 3.128 | -1.73 ± 3.158 | -1.87 ± 2.751 |
| Change From Baseline at Week 44 | -1.05 ± 2.653 | -1.87 ± 2.871 | -2.35 ± 2.768 | -1.60 ± 3.435 | -2.93 ± 2.999 | -2.96 ± 3.311 | -1.09 ± 3.077 | -2.41 ± 3.338 | -2.08 ± 2.932 |
| Change From Baseline at Week 48 | -1.22 ± 2.640 | -1.95 ± 3.001 | -2.87 ± 4.006 | -0.78 ± 2.906 | -2.81 ± 2.789 | -2.89 ± 3.346 | -1.74 ± 3.257 | -1.46 ± 3.800 | -1.75 ± 2.562 |
| Change From Baseline at Week 52 | -1.76 ± 2.420 | -1.53 ± 2.796 | -3.27 ± 2.568 | -1.36 ± 3.019 | -2.20 ± 2.564 | -2.50 ± 3.129 | -1.90 ± 3.306 | -2.20 ± 2.991 | -2.07 ± 2.400 |
| Change From Baseline at Week 60 | -1.89 ± 2.781 | -1.00 ± 1.778 | -1.63 ± 3.097 | -1.20 ± 3.371 | -2.59 ± 2.491 | -2.63 ± 3.885 | -1.17 ± 2.198 | -2.39 ± 3.217 | -2.07 ± 2.843 |
| Change From Baseline at Week 64 | -1.19 ± 2.692 | -2.56 ± 2.525 | -0.43 ± 3.261 | -1.16 ± 2.744 | -2.05 ± 2.327 | -2.40 ± 4.271 | -1.46 ± 2.729 | -2.03 ± 4.805 | -2.38 ± 2.247 |
| log2-transformed mg/L | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 2.08 ± 2.625 | 2.41 ± 1.630 | 0.86 ± 1.942 | 1.42 ± 1.989 | 1.35 ± 1.638 | 1.22 ± 1.865 | 1.23 ± 1.687 | 1.91 ± 1.948 | 2.53 ± 1.803 |
| Change From Baseline at Week 4 | -1.02 ± 1.888 | 0.18 ± 1.323 | -0.70 ± 1.108 | -0.43 ± 1.660 | -0.85 ± 1.585 | -0.73 ± 1.967 | -1.10 ± 1.645 | -1.40 ± 1.382 | -0.97 ± 1.656 |
| Change From Baseline at Week 8 | -0.58 ± 2.105 | -0.22 ± 1.859 | -0.67 ± 1.957 | -0.47 ± 1.912 | -0.85 ± 2.109 | -1.14 ± 2.198 | -0.97 ± 1.980 | -1.48 ± 1.391 | -1.02 ± 1.695 |
| Change From Baseline at Week 12 | -1.22 ± 2.248 | -0.60 ± 2.635 | -1.09 ± 2.151 | -0.66 ± 1.749 | -1.45 ± 1.768 | -1.18 ± 1.814 | -0.93 ± 2.133 | -1.50 ± 1.646 | -0.95 ± 1.646 |
| Change From Baseline at Week 14 | -0.86 ± 2.162 | 0.08 ± 2.194 | -0.43 ± 2.529 | -0.71 ± 2.026 | -1.05 ± 2.045 | -1.10 ± 2.086 | -0.74 ± 1.750 | -1.35 ± 1.720 | -0.98 ± 1.603 |
| Change From Baseline at Week 16 | -1.03 ± 2.061 | -0.19 ± 2.184 | -0.72 ± 2.025 | -0.56 ± 2.112 | -0.61 ± 1.931 | -1.06 ± 2.098 | -0.98 ± 2.030 | -1.50 ± 1.432 | -1.09 ± 1.783 |
| Change From Baseline at Week 20 | -1.27 ± 1.253 | -0.98 ± 2.164 | -0.91 ± 2.855 | -0.44 ± 2.106 | -0.83 ± 2.158 | -0.52 ± 2.399 | -0.98 ± 1.957 | -0.61 ± 2.365 | -1.16 ± 1.718 |
| Change From Baseline at Week 24 | -1.62 ± 1.786 | -1.43 ± 1.914 | -1.44 ± 1.935 | -0.53 ± 2.056 | -0.80 ± 1.811 | -0.97 ± 1.911 | -1.03 ± 1.963 | -1.48 ± 1.517 | -1.14 ± 1.639 |
| Change From Baseline at Week 28 | -1.39 ± 1.585 | -1.00 ± 2.277 | -0.84 ± 2.000 | -0.61 ± 2.078 | -0.73 ± 2.143 | -0.76 ± 1.867 | -0.87 ± 2.125 | -1.60 ± 1.558 | -1.18 ± 1.844 |
| Change From Baseline at Week 32 | -1.23 ± 1.930 | -0.71 ± 1.585 | -1.36 ± 1.937 | -0.58 ± 1.887 | -0.79 ± 2.136 | -0.57 ± 2.027 | -1.35 ± 1.743 | -1.15 ± 1.853 | -1.31 ± 1.988 |
| Change From Baseline at Week 36 | -1.94 ± 2.158 | -1.21 ± 1.951 | -1.18 ± 1.032 | -0.89 ± 2.009 | -1.03 ± 2.015 | -0.95 ± 1.900 | -1.21 ± 2.006 | -1.07 ± 1.441 | -1.18 ± 1.915 |
| Change From Baseline at Week40 | -1.40 ± 2.470 | -1.03 ± 2.294 | -1.92 ± 1.184 | -0.74 ± 2.371 | -1.37 ± 2.262 | -0.84 ± 2.009 | -1.06 ± 1.992 | -1.19 ± 1.390 | -1.60 ± 1.802 |
| Change From Baseline at Week 44 | -1.01 ± 2.243 | -1.07 ± 2.041 | -1.64 ± 1.592 | -0.99 ± 2.154 | -1.47 ± 1.876 | -0.37 ± 2.008 | -0.71 ± 1.841 | -1.03 ± 1.411 | -1.69 ± 1.423 |
| Change From Baseline at Week 48 | -0.97 ± 1.965 | -1.06 ± 2.213 | -1.59 ± 1.530 | -0.77 ± 2.377 | -1.07 ± 1.671 | -0.78 ± 2.213 | -0.84 ± 1.802 | -1.12 ± 1.478 | -1.47 ± 1.670 |
| Change From Baseline at Week 52 | -0.92 ± 3.093 | -0.82 ± 1.873 | -1.94 ± 1.744 | -0.94 ± 1.993 | -1.29 ± 1.756 | -1.13 ± 1.951 | -0.52 ± 1.730 | -1.22 ± 1.456 | -1.54 ± 1.863 |
| Change From Baseline at Week 56 | -1.18 ± 2.111 | -0.96 ± 2.381 | -1.11 ± 1.681 | -0.70 ± 2.227 | -1.12 ± 2.293 | -0.71 ± 2.434 | -0.05 ± 1.966 | -0.82 ± 1.648 | -1.32 ± 2.070 |
| Change From Baseline at Week 60 | -1.19 ± 1.259 | -0.52 ± 2.427 | -1.17 ± 2.435 | -0.64 ± 2.236 | -0.34 ± 2.332 | -0.82 ± 2.135 | -0.88 ± 2.060 | -1.71 ± 1.670 | -1.91 ± 2.213 |
| Change From Baseline at Week 64 | -0.85 ± 1.481 | -1.03 ± 1.776 | -1.66 ± 1.908 | -0.77 ± 2.162 | -1.05 ± 1.950 | -1.22 ± 1.981 | -0.44 ± 1.778 | -1.07 ± 1.870 | -1.69 ± 2.336 |
| pg/mL | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 6.76 ± 0.524 | 6.93 ± 0.300 | 6.89 ± 0.499 | 6.73 ± 0.503 | 6.77 ± 0.520 | 6.69 ± 0.520 | 6.83 ± 0.706 | 6.65 ± 0.467 | 6.83 ± 0.428 |
| Change From Baseline at Week 4 | 0.09 ± 0.458 | -0.01 ± 0.349 | -0.02 ± 0.221 | 3.50 ± 1.051 | 3.73 ± 1.445 | 3.97 ± 1.218 | 4.88 ± 0.987 | 5.29 ± 0.829 | 4.65 ± 0.686 |
| Change From Baseline at Week 8 | -0.10 ± 0.908 | 0.02 ± 0.329 | -0.10 ± 0.267 | 3.18 ± 1.331 | 3.98 ± 1.561 | 3.76 ± 1.443 | 4.87 ± 1.691 | 4.98 ± 1.434 | 4.74 ± 0.891 |
| Change From Baseline at Week 12 | 0.14 ± 0.383 | -0.01 ± 0.329 | -0.17 ± 0.365 | 2.93 ± 1.629 | 3.84 ± 1.613 | 3.75 ± 1.471 | 4.34 ± 2.700 | 4.59 ± 1.840 | 5.03 ± 1.221 |
| Change From Baseline at Week 14 | 0.08 ± 0.474 | 0.28 ± 1.209 | -0.23 ± 0.329 | 2.97 ± 1.598 | 3.95 ± 1.664 | 3.97 ± 1.419 | 4.37 ± 2.724 | 4.68 ± 1.872 | 5.00 ± 0.902 |
| Change From Baseline at Week 16 | -0.05 ± 0.708 | 0.56 ± 1.384 | -0.11 ± 0.305 | 2.99 ± 1.697 | 3.55 ± 1.849 | 3.96 ± 1.406 | 4.40 ± 2.472 | 4.42 ± 2.181 | 4.66 ± 1.069 |
| Change From Baseline at Week 20 | 4.05 ± 0.978 | 3.75 ± 1.543 | 5.19 ± 0.861 | 3.01 ± 1.710 | 3.46 ± 1.678 | 3.96 ± 1.338 | 4.12 ± 2.459 | 3.92 ± 2.248 | 4.40 ± 1.365 |
| Change From Baseline at Week 24 | 2.94 ± 1.140 | 4.17 ± 1.415 | 5.41 ± 0.771 | 2.86 ± 1.881 | 3.57 ± 1.608 | 3.60 ± 2.046 | 3.74 ± 2.346 | 3.69 ± 2.117 | 4.33 ± 1.483 |
| Change From Baseline at Week 28 | 3.04 ± 1.182 | 4.06 ± 1.536 | 5.67 ± 0.742 | 2.87 ± 1.992 | 3.20 ± 1.715 | 3.61 ± 2.155 | 3.55 ± 2.220 | 3.68 ± 2.141 | 4.42 ± 1.548 |
| Change From Baseline at Week 32 | 3.29 ± 1.500 | 3.99 ± 1.497 | 5.62 ± 0.620 | 2.82 ± 1.903 | 3.09 ± 1.760 | 3.92 ± 1.535 | 3.23 ± 2.089 | 3.67 ± 2.044 | 4.39 ± 1.452 |
| Change From Baseline at Week 36 | 3.47 ± 1.247 | 3.90 ± 1.564 | 5.55 ± 0.842 | 2.96 ± 1.813 | 3.25 ± 1.637 | 3.99 ± 1.460 | 3.12 ± 1.854 | 3.83 ± 2.020 | 4.58 ± 1.209 |
| Change From Baseline at Week 40 | 3.56 ± 1.130 | 3.65 ± 1.865 | 5.44 ± 0.951 | 3.04 ± 1.839 | 3.02 ± 1.644 | 4.07 ± 1.582 | 2.95 ± 1.914 | 3.84 ± 2.007 | 4.42 ± 1.450 |
| Change From Baseline at Week 44 | 3.53 ± 1.172 | 3.67 ± 1.671 | 5.34 ± 1.093 | 2.98 ± 1.762 | 2.97 ± 1.769 | 3.89 ± 1.421 | 2.90 ± 1.893 | 4.05 ± 1.823 | 4.57 ± 1.276 |
| Change From Baseline at Week 48 | 3.47 ± 1.156 | 3.42 ± 1.682 | 5.46 ± 1.019 | 2.99 ± 1.684 | 3.01 ± 1.695 | 4.25 ± 1.438 | 3.28 ± 1.789 | 4.11 ± 1.802 | 4.61 ± 1.428 |
| Change From Baseline at Week 52 | 3.70 ± 1.262 | 3.43 ± 1.928 | 5.43 ± 1.211 | 2.94 ± 1.668 | 3.16 ± 1.573 | 4.26 ± 1.325 | 3.10 ± 1.725 | 4.00 ± 2.021 | 4.53 ± 1.565 |
| Change From Baseline at Week 56 | 3.83 ± 1.308 | 3.31 ± 1.961 | 5.35 ± 1.132 | 3.08 ± 1.445 | 3.00 ± 1.719 | 4.24 ± 1.510 | 3.10 ± 1.605 | 4.49 ± 1.553 | 4.74 ± 1.405 |
| Change From Baseline at Week 60 | 3.08 ± 1.718 | 3.51 ± 1.742 | 5.07 ± 1.553 | 2.98 ± 1.710 | 3.31 ± 1.714 | 3.70 ± 1.401 | 3.26 ± 1.672 | 3.72 ± 1.928 | 4.42 ± 1.254 |
| Change From Baseline at Week 64 | 3.31 ± 1.611 | 3.48 ± 1.919 | 4.50 ± 1.900 | 2.64 ± 2.059 | 3.30 ± 1.657 | 3.75 ± 1.383 | 2.85 ± 2.115 | 3.69 ± 2.218 | 4.39 ± 1.118 |
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5.
| Participants | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chroinc) 450 mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|
| ADA at Week 16 | 0 | 0 | 0 | 38 | 18 | 24 | 10 | 17 | 15 |
| NAb at Week 16 | — | — | — | 16 | 7 | 3 | 1 | 3 | 1 |
| ADA at Week 20 | 9 | 9 | 4 | 39 | 20 | 23 | 14 | 18 | 16 |
| NAb at Week 20 | 0 | 0 | 0 | 12 | 7 | 4 | 0 | 5 | 1 |
| ADA at Week 24 | 10 | 9 | 6 | 36 | 21 | 22 | 20 | 18 | 16 |
| NAb at Week 24 | 1 | 2 | 0 | 11 | 4 | 2 | 1 | 4 | 0 |
| ADA at Week 28 | 11 | 12 | 5 | 35 | 22 | 24 | 18 | 19 | 15 |
| NAb at Week 28 | 4 | 3 | 0 | 13 | 5 | 4 | 1 | 4 | 0 |
| ADA at Week 32 | 11 | 14 | 6 | 34 | 21 | 23 | 18 | 19 | 18 |
| NAb at Week 32 | 4 | 3 | 0 | 10 | 4 | 1 | 0 | 3 | 1 |
| ADA at Week 36 | 11 | 14 | 6 | 33 | 17 | 20 | 19 | 19 | 16 |
| NAb at Week 36 | 3 | 3 | 1 | 10 | 2 | 3 | 0 | 5 | 0 |
| ADA at Week 40 | 11 | 11 | 5 | 34 | 19 | 22 | 17 | 18 | 18 |
| NAb at Week 40 | 3 | 1 | 1 | 8 | 3 | 2 | 0 | 2 | 0 |
| ADA at Week 44 | 10 | 12 | 6 | 30 | 18 | 20 | 18 | 16 | 15 |
| NAb at Week 44 | 3 | 1 | 1 | 7 | 4 | 3 | 0 | 1 | 0 |
| ADA at Week 48 | 11 | 12 | 5 | 29 | 19 | 20 | 18 | 17 | 14 |
| NAb at Week 48 | 2 | 1 | 1 | 7 | 3 | 3 | 0 | 1 | 1 |
| ADA at Week 52 | 11 | 11 | 5 | 28 | 19 | 17 | 16 | 17 | 13 |
| NAb at Week 52 | 2 | 2 | 1 | 8 | 5 | 2 | 1 | 1 | 0 |
| ADA at Week 56 | 10 | 11 | 4 | 28 | 16 | 21 | 16 | 15 | 13 |
| NAb at Week 56 | 2 | 1 | 1 | 6 | 5 | 2 | 0 | 2 | 0 |
| ADA at Week 60 | 9 | 11 | 6 | 27 | 18 | 19 | 13 | 16 | 16 |
| NAb at Week 60 | 2 | 0 | 2 | 5 | 3 | 3 | 0 | 3 | 0 |
| ADA at Week 64 | 10 | 11 | 10 | 28 | 18 | 20 | 17 | 16 | 17 |
| NAb at Week 64 | 0 | 1 | 1 | 7 | 4 | 2 | 1 | 3 | 0 |
Collected over Induction Period: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.) Chronic Period: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction Period: Placebo | 0/45 (0%) | 4/45 (8.9%) | 16/45 (35.6%) |
| Induction Period: PF-06480605 50 mg | 0/47 (0%) | 3/47 (6.4%) | 11/47 (23.4%) |
| Induction Period: PF-06480605 150 mg | 0/62 (0%) | 1/62 (1.6%) | 20/62 (32.3%) |
| Induction Period: PF-06480605 450 mg | 0/91 (0%) | 4/91 (4.4%) | 34/91 (37.4%) |
| Placebo (Induction) to PF-06480605 (Chronic) 50 mg | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Placebo (Induction) to PF-06480605 (Chronic) 150 mg | 0/14 (0%) | 0/14 (0%) | 9/14 (64.3%) |
| Placebo (Induction) to PF-06480605 (Chronic) 450mg | 0/14 (0%) | 0/14 (0%) | 9/14 (64.3%) |
| PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | 0/46 (0%) | 5/46 (10.9%) | 24/46 (52.2%) |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | 0/27 (0%) | 1/27 (3.7%) | 15/27 (55.6%) |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | 0/30 (0%) | 0/30 (0%) | 12/30 (40%) |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | 0/26 (0%) | 2/26 (7.7%) | 14/26 (53.8%) |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | 0/26 (0%) | 1/26 (3.8%) | 15/26 (57.7%) |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | 0/29 (0%) | 4/29 (13.8%) | 14/29 (48.3%) |
| Event | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chronic) 450mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Colitis ulcerativeGastrointestinal disorders | 1/45 | 1/47 | 1/62 | 1/91 | 0/12 | 0/14 | 0/14 | 1/46 | 0/27 | 0/30 | 1/26 | 0/26 | 0/29 |
| COVID-19 pneumoniaInfections and infestations | 0/45 | 1/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 1/26 | 0/26 | 0/29 |
| Haemorrhoid operationSurgical and medical procedures | 0/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 1/26 | 0/29 |
| Abortion spontaneous completePregnancy, puerperium and perinatal conditions | 0/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 1/27 | 0/30 | 0/26 | 0/26 | 0/29 |
| AnaemiaBlood and lymphatic system disorders | 0/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 0/26 | 1/29 |
| Coronary artery stenosisCardiac disorders | 0/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 0/26 | 1/29 |
| Intestinal perforationGastrointestinal disorders | 0/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 0/26 | 1/29 |
| Lower gastrointestinal haemorrhageGastrointestinal disorders | 0/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 0/26 | 1/29 |
| Hypereosinophilic syndromeBlood and lymphatic system disorders | 1/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 0/26 | 0/29 |
| VomitingGastrointestinal disorders | 1/45 | 0/47 | 0/62 | 0/91 | 0/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 0/26 | 0/29 |
| Event | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Placebo (Induction) to PF-06480605 (Chronic) 50 mg | Placebo (Induction) to PF-06480605 (Chronic) 150 mg | Placebo (Induction) to PF-06480605 (Chronic) 450mg | PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Colitis ulcerativeGastrointestinal disorders | 0/45 | 2/47 | 1/62 | 3/91 | 0/12 | 1/14 | 0/14 | 8/46 | 4/27 | 2/30 | 6/26 | 3/26 | 1/29 |
| SARS-CoV-2 test positiveInvestigations | 0/45 | 0/47 | 2/62 | 1/91 | 1/12 | 2/14 | 2/14 | 1/46 | 5/27 | 3/30 | 4/26 | 3/26 | 2/29 |
| PyrexiaGeneral disorders | 1/45 | 0/47 | 1/62 | 5/91 | 2/12 | 1/14 | 1/14 | 2/46 | 2/27 | 2/30 | 3/26 | 0/26 | 1/29 |
| AnaemiaBlood and lymphatic system disorders | 4/45 | 2/47 | 5/62 | 2/91 | 1/12 | 2/14 | 0/14 | 4/46 | 1/27 | 0/30 | 3/26 | 3/26 | 2/29 |
| Injection site reactionGeneral disorders | 1/45 | 1/47 | 3/62 | 2/91 | 0/12 | 0/14 | 1/14 | 1/46 | 3/27 | 0/30 | 1/26 | 0/26 | 0/29 |
| Blood creatine phosphokinase increasedInvestigations | 2/45 | 1/47 | 1/62 | 1/91 | 0/12 | 0/14 | 0/14 | 3/46 | 0/27 | 0/30 | 1/26 | 1/26 | 3/29 |
| NauseaGastrointestinal disorders | 1/45 | 3/47 | 2/62 | 2/91 | 0/12 | 0/14 | 1/14 | 1/46 | 2/27 | 3/30 | 2/26 | 1/26 | 0/29 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/45 | 0/47 | 0/62 | 2/91 | 1/12 | 0/14 | 1/14 | 0/46 | 0/27 | 3/30 | 0/26 | 1/26 | 0/29 |
| HeadacheNervous system disorders | 1/45 | 2/47 | 2/62 | 9/91 | 1/12 | 1/14 | 1/14 | 3/46 | 2/27 | 0/30 | 2/26 | 2/26 | 1/29 |
| Angular cheilitisGastrointestinal disorders | 0/45 | 0/47 | 0/62 | 0/91 | 1/12 | 0/14 | 0/14 | 0/46 | 0/27 | 0/30 | 0/26 | 0/26 | 0/29 |
Safety analysis population included all participants who received at least one dose of investigational product (IP). Participants were analyzed according to the product they received.
| Age, Continuous(years) | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Total |
|---|---|---|---|---|---|
| Mean | 39.9 ± 12.90 | 37.8 ± 13.91 | 42.2 ± 13.02 | 41.6 ± 13.79 | 40.7 ± 13.48 |
| Sex: Female, Male(Participants) | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Total |
|---|---|---|---|---|---|
| Female | 21 | 19 | 23 | 36 | 99 |
| Male | 24 | 28 | 39 | 55 | 146 |
| Ethnicity (NIH/OMB)(Participants) | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 2 | 3 | 10 |
| Not Hispanic or Latino | 42 | 43 | 55 | 86 | 226 |
| Unknown or Not Reported | 1 | 1 | 5 | 2 | 9 |
| Race (NIH/OMB)(Participants) | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 0 | 2 | 5 |
| Asian | 13 | 9 | 9 | 18 | 49 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 1 |
| White | 30 | 35 | 49 | 70 | 184 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 4 | 1 | 6 |
Showing the first 100 of 166 sites across 23 countries.
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