A Phase 2 interventional study of PF-06480605 in Colitis, Ulcerative, sponsored by Telavant, Inc.. Completed at 28 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Telavant, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.
This is a Phase 2a, single arm, two-stage study in subjects with moderate to severe ulcerative colitis. Subjects will receive 500 mg of PF-06480605 intravenously every 2 weeks for a total of 7 doses. Blood, stool, and tissue samples will be collected at various time points throughout the study to evaluate safety, tolerability, efficacy, pharmacokinetics, and immunogenicity. Duration of participation for subjects will be approximately 8 months.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Telavant, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects receiving the following therapies within the designated time period:
PF-06480605 500 mg IV Q2W X 7 doses
Drug: PF-06480605
PF-06480605 500 mg IV Q2W x 7 Doses
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious AE (SAE) was any untoward medical occurrence at any dose that (1) resulted in death; (2) was life-threatening (immediate risk of death); (3) required inpatient hospitalization or prolongation of existing hospitalization; (4) resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); (5) resulted in congenital anomaly/birth defect. A treatment-emergent AE (TEAE) was defined as an event that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state. Causality to study treatment was determined by the investigator.
Time frame: Day 1 up to final onsite visit (Week 26)
Number of Participants With Laboratory Abnormalities
The following parameters were evaluated: hematology (hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, and prothrombin time), clinical chemistry (bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, glucose, and creatine kinase), and urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, and bacteria).
Time frame: Day 1 up to final onsite visit (Week 26)
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Vital signs evaluation included sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse rate. Sitting blood pressure was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mm Hg). The same size BP cuff which had been properly sized and calibrated was used to measure BP each time. Number of participants with vital signs data meeting pre-specified criteria is presented.
Time frame: Baseline up to final onsite visit (Week 26)
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
All scheduled 12-lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Number of participants with ECG data meeting pre-specified criteria is presented.
Time frame: Baseline up to final onsite visit (Week 26)
Percentage of Participants Achieving Endoscopic Improvement at Week 14, Based on Uniformly Minimum-Variance Unbiased Estimator (UMVUE) - Per Protocol Analysis Set
Endoscopic improvement at Week 14 was defined as Mayo endoscopic sub-score of 0 or 1, and without friability. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2=3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Time frame: Week 14
Percentage of Participants Achieving Remission at Week 14 - Full Analysis Set
Remission: total Mayo score \<=2 with no individual subscore \>1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, no friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Time frame: Week 14
Percentage of Participants Achieving Remission at Week 14 - Per Protocol Analysis Set
Remission: total Mayo score \<=2 with no individual subscore \>1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, no friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Time frame: Week 14
Percentage of Participants Achieving Endoscopic Remission at Week 14 - Full Analysis Set
Endoscopic remission at Week 14 was defined as Mayo endoscopic sub-score of 0. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Time frame: Week 14
Maximum Serum Concentration (Cmax) of PF-06480605
Maximum serum concentration (Cmax) of PF-06480605 was observed directly from data.
Time frame: 30 minutes pre-dose and 1 hour post-dose on Day 85
Average Serum Concentration (Cav) of PF-06480605
Average serum concentration (Cav) of PF-06480605 was calculated as AUCtau/tau, where tau was the dosing interval (tau=14 days), and AUCtau was the area under the concentration-time profile from time 0 to time tau.
Time frame: 30 minutes pre-dose and 1 hour post-dose on Day 85
Lowest Serum Concentration (Cmin) of PF-06480605
Lowest serum concentration (Cmin) of PF-06480605 was observed directly from data.
Time frame: 30 minutes pre-dose and 1 hour post-dose on Day 85
Area Under the Concentration-time Profile From Time Zero to Time Tau (AUCtau) of PF-06480605
AUCtau of PF-06480605 was calculated using linear/log trapezoidal method; tau was the dosing interval (=14 days).
Time frame: 30 minutes pre-dose and 1 hour post-dose on Day 85
Percentage of Participants Who Developed Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Serum samples were analyzed using a new ADA assay with acid pre-treatment followed by a more drug-tolerant cell-based NAb assay. For ADA assay with acid pre-treatment, the sample was deemed positive if log titer \>=1.30; for cell-based NAb assay, the sample was deemed positive if log titer \>=0.699.
Time frame: Day 1 up to final onsite visit (Week 26)
Change From Baseline in Fecal Calprotectin
Fecal calprotectin has been used to detect intestinal inflammation (colitis or enteritis) and can serve as a biomarker for inflammatory bowel diseases. Elevated fecal calprotectin levels indicate migration of neutrophils into the intestinal mucosa, which occurs during intestinal inflammation.
Time frame: Baseline, Weeks 2, 8, 12 and 26
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
HsCRP is used mainly as a marker of inflammation.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
TL1A is a member of the tumor necrosis factor (TNF) family of cytokines. The investigational product of this study PF-06480605 is a fully human neutralizing antibody against TL1A.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26
| Milestone | PF-06480605 500 mg IV |
|---|---|
| Started | 50 |
| Completed | 49 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | PF-06480605 500 mg IV |
|---|---|
| Started | 49 |
| Completed | 42 |
| Not completed | 7 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Withdrawal of consent | 2 |
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious AE (SAE) was any untoward medical occurrence at any dose that (1) resulted in death; (2) was life-threatening (immediate risk of death); (3) required inpatient hospitalization or prolongation of existing hospitalization; (4) resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); (5) resulted in congenital anomaly/birth defect. A treatment-emergent AE (TEAE) was defined as an event that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state. Causality to study treatment was determined by the investigator.
| Participants | PF-06480605 500 mg IV |
|---|---|
| All-causality AEs | 33 |
| All-causality SAEs | 3 |
| Treatment-related AEs | 8 |
| Treatment-related SAEs | 1 |
| Withdrew due to AEs | 1 |
The following parameters were evaluated: hematology (hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, and prothrombin time), clinical chemistry (bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, glucose, and creatine kinase), and urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, and bacteria).
| Participants | PF-06480605 500 mg IV |
|---|---|
| Number of Participants With Laboratory Abnormalities | 38 |
Vital signs evaluation included sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse rate. Sitting blood pressure was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mm Hg). The same size BP cuff which had been properly sized and calibrated was used to measure BP each time. Number of participants with vital signs data meeting pre-specified criteria is presented.
| Participants | PF-06480605 500 mg IV |
|---|---|
| Sitting DBP <50 mm Hg | 1 |
| Sitting SBP <90 mm Hg | 4 |
| Sitting pulse rate <40 beats per minute (bpm) | 0 |
| Sitting pulse rate >120 bpm | 1 |
| Sitting DBP increase from baseline >=20 mm Hg | 2 |
| Sitting SBP increase from baseline >=30 mm Hg | 5 |
| Sitting DBP decrease from baseline >=20 mm Hg | 7 |
| Sitting SBP decrease from baseline >=30 mm Hg | 1 |
All scheduled 12-lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Number of participants with ECG data meeting pre-specified criteria is presented.
| Participants | PF-06480605 500 mg IV |
|---|---|
| PR interval >=300 milliseconds (msec) | 0 |
| QRS duration >=140 msec | 0 |
| QT interval >=500 msec | 0 |
| QTcF interval: 450 to <480 msec | 5 |
| QTcF interval: 480 to <500 msec | 0 |
| QTcF interval: >=500 msec | 0 |
| PR interval increase from baseline >=25%/50% | 0 |
| QRS duration increase from baseline >=50% | 0 |
| QTcF increase from baseline: 30 to <60 msec | 9 |
| QTcF increase from baseline: >=60 msec | 1 |
Endoscopic improvement at Week 14 was defined as Mayo endoscopic sub-score of 0 or 1, and without friability. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2=3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
| percentage of participants | PF-06480605 500 mg IV |
|---|---|
| Percentage of Participants Achieving Endoscopic Improvement at Week 14, Based on Uniformly Minimum-Variance Unbiased Estimator (UMVUE) - Per Protocol Analysis Set | 38.20 (23.82 to 53.68) |
Remission: total Mayo score \<=2 with no individual subscore \>1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, no friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
| percentage of participants | PF-06480605 500 mg IV |
|---|---|
| Percentage of Participants Achieving Remission at Week 14 - Full Analysis Set | 24.00 (13.06 to 38.17) |
Remission: total Mayo score \<=2 with no individual subscore \>1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, no friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
| percentage of participants | PF-06480605 500 mg IV |
|---|---|
| Percentage of Participants Achieving Remission at Week 14 - Per Protocol Analysis Set | 26.67 (14.60 to 41.94) |
Endoscopic remission at Week 14 was defined as Mayo endoscopic sub-score of 0. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
| percentage of participants | PF-06480605 500 mg IV |
|---|---|
| Percentage of Participants Achieving Endoscopic Remission at Week 14 - Full Analysis Set | 10.00 (3.33 to 21.81) |
Maximum serum concentration (Cmax) of PF-06480605 was observed directly from data.
| nanograms (ng)/milliliters (mL) | PF-06480605 500 mg IV |
|---|---|
| Maximum Serum Concentration (Cmax) of PF-06480605 | 263400 ± 54 |
Average serum concentration (Cav) of PF-06480605 was calculated as AUCtau/tau, where tau was the dosing interval (tau=14 days), and AUCtau was the area under the concentration-time profile from time 0 to time tau.
| nanograms (ng)/milliliters (mL) | PF-06480605 500 mg IV |
|---|---|
| Average Serum Concentration (Cav) of PF-06480605 | 171400 ± 45 |
Lowest serum concentration (Cmin) of PF-06480605 was observed directly from data.
| ng/mL | PF-06480605 500 mg IV |
|---|---|
| Lowest Serum Concentration (Cmin) of PF-06480605 | 87650 ± 50 |
AUCtau of PF-06480605 was calculated using linear/log trapezoidal method; tau was the dosing interval (=14 days).
| ng.hr/mL | PF-06480605 500 mg IV |
|---|---|
| Area Under the Concentration-time Profile From Time Zero to Time Tau (AUCtau) of PF-06480605 | 57610000 ± 45 |
Serum samples were analyzed using a new ADA assay with acid pre-treatment followed by a more drug-tolerant cell-based NAb assay. For ADA assay with acid pre-treatment, the sample was deemed positive if log titer \>=1.30; for cell-based NAb assay, the sample was deemed positive if log titer \>=0.699.
| percentage of participants | PF-06480605 500 mg IV |
|---|---|
| ADA | 82.0 |
| NAb | 10.0 |
Fecal calprotectin has been used to detect intestinal inflammation (colitis or enteritis) and can serve as a biomarker for inflammatory bowel diseases. Elevated fecal calprotectin levels indicate migration of neutrophils into the intestinal mucosa, which occurs during intestinal inflammation.
| micrograms/grams | PF-06480605 500 mg IV |
|---|---|
| Baseline | 3662.25 ± 3556.331 |
| Week 2 change from baseline | -1861.38 ± 3565.861 |
| Week 8 change from baseline | -2509.43 ± 3751.843 |
| Week 12 change from baseline | -2844.26 ± 3623.922 |
| Week 26 change from baseline | -2726.97 ± 3673.063 |
HsCRP is used mainly as a marker of inflammation.
| micrograms/deciliter | PF-06480605 500 mg IV |
|---|---|
| Baseline | 0.9316 ± 1.15545 |
| Week 2 change from baseline | -0.2136 ± 1.43785 |
| Week 4 change from baseline | -0.4883 ± 1.10820 |
| Week 6 change from baseline | -0.3314 ± 1.39605 |
| Week 8 change from baseline | -0.4875 ± 1.00870 |
| Week 10 change from baseline | -0.5738 ± 0.97608 |
| Week 12 change from baseline | -0.4242 ± 1.18416 |
| Week 14 change from baseline | -0.3983 ± 1.21181 |
| Week 16 change from baseline | -0.5070 ± 1.37798 |
| Week 20 change from baseline | -0.4728 ± 1.11950 |
| Week 24 change from baseline | -0.5334 ± 1.03224 |
| Week 26 change from baseline | -0.3453 ± 1.37576 |
TL1A is a member of the tumor necrosis factor (TNF) family of cytokines. The investigational product of this study PF-06480605 is a fully human neutralizing antibody against TL1A.
| picograms/mL | PF-06480605 500 mg IV |
|---|---|
| Baseline | 103.9 ± 32.05 |
| Week 2 change from baseline | 3390.4 ± 1349.87 |
| Week 4 change from baseline | 5308.9 ± 2073.59 |
| Week 6 change from baseline | 6908.7 ± 3278.23 |
| Week 8 change from baseline | 7319.3 ± 3587.14 |
| Week 10 change from baseline | 7175.7 ± 4095.36 |
| Week 12 change from baseline | 6446.3 ± 4422.46 |
| Week 14 change from baseline | 6539.1 ± 4836.21 |
| Week 16 change from baseline | 5316.6 ± 4941.13 |
| Week 20 change from baseline | 3903.3 ± 4092.26 |
| Week 24 change from baseline | 3190.2 ± 3172.22 |
| Week 26 change from baseline | 3084.3 ± 2964.75 |
Collected over Day 1 up to final onsite visit (Week 26). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-06480605 500 mg IV | 0/50 (0%) | 3/50 (6%) | 20/50 (40%) |
| Event | PF-06480605 500 mg IV |
|---|---|
| Colitis ulcerativeGastrointestinal disorders | 2/50 |
| PeritonitisInfections and infestations | 1/50 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/50 |
| Event | PF-06480605 500 mg IV |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/50 |
| Colitis ulcerativeGastrointestinal disorders | 5/50 |
| Abdominal painGastrointestinal disorders | 3/50 |
| NauseaGastrointestinal disorders | 3/50 |
| NasopharyngitisInfections and infestations | 3/50 |
| PharyngitisInfections and infestations | 3/50 |
| Back painMusculoskeletal and connective tissue disorders | 3/50 |
The baseline analysis population included all participants enrolled in the study.
| Age, Continuous(years) | PF-06480605 500 mg IV |
|---|---|
| Mean | 40.0 ± 14.52 |
| Sex: Female, Male(Participants) | PF-06480605 500 mg IV |
|---|---|
| Female | 22 |
| Male | 28 |
| Race/Ethnicity, Customized(Participants) | PF-06480605 500 mg IV |
|---|---|
| White | 48 |
| Asian | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Telavant, Inc.