A Phase 2 interventional study of PF-06687234 and Placebo in Ulcerative Colitis, sponsored by Pfizer. Terminated at 34 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-12-28.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
Among 42 studies in Colitis, Ulcerative by Pfizer — 3 open to participants now, 7 under way, 2 of them phase 3. Colitis, Ulcerative · Pfizer.
Among the 42 studies in Colitis, Ulcerative by Pfizer, this one is the 23rd largest by enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2017, is one of 12 in phase 2, and was the 15th registered.
1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.
Browse Colitis, Ulcerative studies →3 of the 42 studies in Colitis, Ulcerative by Pfizer are open now, in 12 countries. Recruiting first, the newest first:
Pfizer · Sites in United States, Australia, Canada and 7 more countries
Ages 2–11
Pfizer · Sites in United States
Ages 18–64
Pfizer · Sites in United States, Japan, Poland and 2 more countries
Ages 12–17
By country, each count listing its studies:
Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 70 across 1,237 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 129 across the 24 interventional studies, 276 across the 16 observational. Of the 32 that completed or were terminated, 26 (81%) have results posted.
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Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
3 of the studies in Colitis, Ulcerative by Pfizer that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04624230Phase 3PfizerEvaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | 2027-03-17 |
| NCT06294925PfizerA Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis | 2027-05-13 |
| NCT06398626PfizerAn Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis | 2027-10-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 42 studies in Colitis, Ulcerative by Pfizer, from their registry updates:
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The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.
This is a Phase 2a, double-blind, placebo-controlled, parallel group study in subjects with active ulcerative colitis and a non-remission (partial) response to infliximab. All enrolled subjects must have been on infliximab for a minimum of 14 weeks with last dose 8 weeks prior to the date of randomization. Subjects will be randomly assigned to 1 of 2 treatment arms (PF-06687234 or placebo) administered subcutaneously every week for a total of 12 doses. Blood, stool and tissue samples will be collected at various time points throughout the study to evaluate efficacy, safety, tolerability, pharmacokinetics and immunogenicity. Duration of participation for subjects will be approximately 6 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects receiving the following therapies within the designated time period:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PF-06687234 subcutaneous (SC) weekly (QW) x 12 doses
Drug: PF-06687234
PF-06687234 matched Placebo SC QW x 12 doses
Drug: Placebo
SC QW
Also known as: Investigational product
SC QW
Also known as: PF-06687234 matched placebo
Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Endoscopic Subscore <=1, Observed Cases)
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) \<=2, no individual subscore \>1, traditional endoscopic subscore \<=1 (where mild friability was scored as of 1; moderate or severe friability was scored as 2) and rectal bleeding subscore=0. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving modified clinical remission was calculated based on the number of participants with observed data.
Time frame: Week 12
Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Mayo Endoscopic Subscore <=1, Treatment Failure Approach)
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) \<=2, no individual subscore \>1, traditional endoscopic subscore \<=1 (where mild friability was scored as of 1; moderate or severe friability was scored as 2) and rectal bleeding subscore=0. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
Time frame: Week 12
Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Observed Cases)
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) with endoscopic subscore = 0 or 1 (where any friability was scored as a mayo endoscopic subscore of 2), stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving modified clinical remission was calculated based on the number of participants with observed data.
Time frame: Week 12
Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Treatment Failure Approach)
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) with endoscopic subscore = 0 or 1 (where any friability was scored as a mayo endoscopic subscore of 2), stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
Time frame: Week 12
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment.
Time frame: Baseline (Day 1) through and including a minimum of 28 calendar days after the last administration of the investigational products (22 weeks in total)
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment. Treatment-related AEs were also determined by the investigator.
Time frame: Baseline (Day 1) through and including a minimum of 28 calendar days after the last administration of the investigational products (22 weeks in total)
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
The laboratory tests as defined in the protocol, including hematology, chemistry, urinalysis and other, were performed. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time frame: From baseline through Week 16
Number of Participants With Categorical Vital Signs
Single sitting blood pressure (BP), pulse rate, and temperature were measured. At Day 1 and Week 1, BP and pulse were collected approximately 30 minutes prior to dosing, approximately 30 minutes post dosing and approximately 1 hour post dosing. For participants with no safety issues (eg, severe injection site reactions, severe elevations BP and/or pulse), BP and pulse were collected approximately 30 minutes prior to dosing and approximately 30 minutes post dosing from Weeks 2-16. Vital signs were analyzed as per pre-specified categories.
Time frame: From baseline through Week 16
Number of Participants With Categorical Electrocardiogram (ECG) Data
Twelve (12) lead ECGs were collected. All scheduled ECGs were performed after the participants had rested quietly for at least 10 minutes in a supine position. When the timing of these measurements coincided with a blood collection, the ECG was obtained prior to the nominal time of the blood collection, blood pressure, and pulse rate. ECG data were analyzed as per pre-specified categories. PR=pulse rate; QTc=QT interval corrected for heart rate; QTcF=QTc corrected using Fridericia's formula.
Time frame: From baseline through Week 16
Percentage of Participants With Endoscopic Improvement at Week 12 ( Observed Cases)
Endoscopic improvement is defined as a decrease of \>=1 point in a modified endoscopic subscore (any friability is scored as 2) or an absolute endoscopy score of \<=1 without friability. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving endoscopic improvement was calculated based on the number of participants with observed data.
Time frame: Week 12
Percentage of Participants With Endoscopic Improvement at Week 12 ( Treatment Failure Approach)
Endoscopic improvement is defined as a decrease of \>=1 point in a modified endoscopic subscore (any friability is scored as 2) or an absolute endoscopy score of \<=1 without friability. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
Time frame: Week 12
Percentage of Participants Achieving Geboes Index Remission at Week 12 (Observed Cases)
Geboes index is a structured six-grade classification system ordered as follows: 0, structural changes (sub-grade: 0-0.3); 1, chronic inflammatory infiltrate (sub-grade: 1-1.3); 2, lamina propria neutrophils and eosinophils (sub-grade: 2A-2B.3); 3, neutrophils in epithelium (sub-grade: 3-3.3); 4, crypt destruction (sub-grade: 4-4.3); and 5, erosion and ulceration (sub-grade: 5-5.4). The final index ranges from 0 to 5.4, with low score associated with no inflammation or less inflammation and high score associated with severe inflammation or ulceration. Geboes index remission was defined as Geboes index \< 3 and Grade 3 \< 3.1 at week 12. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving Geboes index remission was calculated based on the number of participants with observed data.
Time frame: Week 12
Change From Baseline in Robart's Histology Index at Week 12 (Observed Cases)
Robart's histology index is based on the Geboes scores, and the final score is obtained by the summation of four main items (chronic inflammatory infiltrate level, lamina propria neutrophils, neutrophils in the epithelium, and erosion or ulceration), which are classified from 0 (no inflammation) to 3 (severe inflammation or ulceration), yielding a final score that ranges between 0 (no inflammation) and 33 (severe inflammation or ulceration). Participants with missing values were handled by observed case approach (the missing data were used as is).
Time frame: Week 12
Percentage of Participants With a Clinical Response at Week 12 (Observed Cases)
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response is defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one-point decrease or absolute score of 0 or 1 in rectal bleeding subscore. Participants with missing values were handled by observed case approach (the missing data were used as is).
Time frame: Week 12
Percentage of Participants With a Clinical Response at Week 12 (Treatment Failure Approach)
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response is defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one-point decrease or absolute score of 0 or 1 in rectal bleeding subscore. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
Time frame: Week 12
Percentage of Participants With Change From Baseline in Derived Partial Mayo Score of <=2 With no Individual Subscore >1 at Weeks 2, 4, 8 and 12 (Observed Cases)
The Mayo score is determined by the summation of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 (normal) to 3 (worst). Derived partial mayo score is defined as total Mayo score excluding the endoscopic subscore (stool frequency, rectal bleeding and PGA only), ranging from 0 (normal) to 9 (the most severe). The percentages of participants with change from baseline in derived partial Mayo score of \<=2 with no individual subscore \>1 at Weeks 2, 4, 8 and 12 were calculated for this endpoint. Participants with missing values were handled by observed case approach (the missing data were used as is). Generalized Linear Mixed Model (GLMM) was used with fixed effects of treatment, visit and treatment by visit interaction.
Time frame: Baseline, Weeks 2, 4, 8 and 12
Serum Concentrations of PF-06687234 20 mg
Samples for serum PF-06687234 concentration were collected approximately 30 minutes prior to dosing. Concentration values below the lower limit of quantification were excluded when calculating the geometric mean (geometric coefficient of variation).
Time frame: Prior to dosing on Day 1 and at Weeks 1, 3, 7, 11, 12 (168 hours post dose) and 16
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Plasma samples were analyzed for anti PF-06687234, anti PF-06687234 IL-10 neutralizing antibody (AB) and anti PF-06687234 single chain variable fragment (scFv) neutralizing AB. Samples inadvertently analyzed were excluded.
Time frame: At screening, Day 1, Weeks 3, 7, 11, 12 and 16 (prior to dosing)
A total of 46 participants were screened , of whom 20 were randomized and treated (10 participants each in the Placebo + Infliximab and PF-06687234 20 mg + Infliximab treatment groups). Fifteen participants completed the treatment.
| Milestone | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Started | 10 | 10 |
| Treated | 10 | 10 |
| Completed | 8 | 7 |
| Not completed | 2 | 3 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) \<=2, no individual subscore \>1, traditional endoscopic subscore \<=1 (where mild friability was scored as of 1; moderate or severe friability was scored as 2) and rectal bleeding subscore=0. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving modified clinical remission was calculated based on the number of participants with observed data.
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with missing data | NA (NA to NA) | NA (NA to NA) |
| Participants with observed data | 12.5 (0.6 to 50.0) | 14.3 (0.7 to 55.0) |
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) \<=2, no individual subscore \>1, traditional endoscopic subscore \<=1 (where mild friability was scored as of 1; moderate or severe friability was scored as 2) and rectal bleeding subscore=0. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Mayo Endoscopic Subscore <=1, Treatment Failure Approach) | 10 (0.5 to 44.4) | 10 (0.5 to 44.4) |
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) with endoscopic subscore = 0 or 1 (where any friability was scored as a mayo endoscopic subscore of 2), stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving modified clinical remission was calculated based on the number of participants with observed data.
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with missing data | NA (NA to NA) | NA (NA to NA) |
| Participants with observed data | 0 (0.0 to 34.9) | 14.3 (0.7 to 55.4) |
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Modified clinical remission is defined as a modified total Mayo Score (total Mayo score excluding the PGA subscore) with endoscopic subscore = 0 or 1 (where any friability was scored as a mayo endoscopic subscore of 2), stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Treatment Failure Approach) | 0 (0.0 to 26.7) | 10 (0.5 to 44.4) |
Endoscopic improvement is defined as a decrease of \>=1 point in a modified endoscopic subscore (any friability is scored as 2) or an absolute endoscopy score of \<=1 without friability. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving endoscopic improvement was calculated based on the number of participants with observed data.
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with missing data | NA (NA to NA) | NA (NA to NA) |
| Participants with observed data | 25.0 (4.6 to 65.1) | 57.1 (22.5 to 87.1) |
Endoscopic improvement is defined as a decrease of \>=1 point in a modified endoscopic subscore (any friability is scored as 2) or an absolute endoscopy score of \<=1 without friability. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Percentage of Participants With Endoscopic Improvement at Week 12 ( Treatment Failure Approach) | 20.0 (3.7 to 55.6) | 40.0 (15.0 to 73.3) |
Geboes index is a structured six-grade classification system ordered as follows: 0, structural changes (sub-grade: 0-0.3); 1, chronic inflammatory infiltrate (sub-grade: 1-1.3); 2, lamina propria neutrophils and eosinophils (sub-grade: 2A-2B.3); 3, neutrophils in epithelium (sub-grade: 3-3.3); 4, crypt destruction (sub-grade: 4-4.3); and 5, erosion and ulceration (sub-grade: 5-5.4). The final index ranges from 0 to 5.4, with low score associated with no inflammation or less inflammation and high score associated with severe inflammation or ulceration. Geboes index remission was defined as Geboes index \< 3 and Grade 3 \< 3.1 at week 12. Participants with missing values were handled by observed case approach (the missing data were used as is). The percentage of participants achieving Geboes index remission was calculated based on the number of participants with observed data.
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with missing data | NA (NA to NA) | NA (NA to NA) |
| Participant with observed data | 62.5 (28.9 to 88.9) | 37.5 (11.1 to 71.1) |
Robart's histology index is based on the Geboes scores, and the final score is obtained by the summation of four main items (chronic inflammatory infiltrate level, lamina propria neutrophils, neutrophils in the epithelium, and erosion or ulceration), which are classified from 0 (no inflammation) to 3 (severe inflammation or ulceration), yielding a final score that ranges between 0 (no inflammation) and 33 (severe inflammation or ulceration). Participants with missing values were handled by observed case approach (the missing data were used as is).
| Scores on a scale | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with missing data | NA (NA to NA) | NA (NA to NA) |
| Participants with observed data | -12.96 (-20.60 to -5.32) | -7.16 (-14.81 to 0.48) |
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response is defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one-point decrease or absolute score of 0 or 1 in rectal bleeding subscore. Participants with missing values were handled by observed case approach (the missing data were used as is).
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with missing data | NA (NA to NA) | NA (NA to NA) |
| Participants with observed data | 37.5 (11.1 to 71.1) | 85.7 (44.6 to 99.3) |
The Mayo score consists of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response is defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one-point decrease or absolute score of 0 or 1 in rectal bleeding subscore. Participants with missing values were handled by treatment failure approach (participants who had missing value for any reasons were considered as treatment failures).
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Percentage of Participants With a Clinical Response at Week 12 (Treatment Failure Approach) | 30.0 (8.7 to 61.9) | 60.0 (26.7 to 85.0) |
The Mayo score is determined by the summation of 4 subscores (Endoscopic, stool frequency, rectal bleeding and Physician's global assessment \[PGA\]), each graded 0 (normal) to 3 (worst). Derived partial mayo score is defined as total Mayo score excluding the endoscopic subscore (stool frequency, rectal bleeding and PGA only), ranging from 0 (normal) to 9 (the most severe). The percentages of participants with change from baseline in derived partial Mayo score of \<=2 with no individual subscore \>1 at Weeks 2, 4, 8 and 12 were calculated for this endpoint. Participants with missing values were handled by observed case approach (the missing data were used as is). Generalized Linear Mixed Model (GLMM) was used with fixed effects of treatment, visit and treatment by visit interaction.
| Percentage of participants (%) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Week 2 | 50.0 (21.0 to 79.0) | 50.0 (21.0 to 79.0) |
| Week 4 | 50.0 (21.0 to 79.0) | 60.0 (27.9 to 85.3) |
| Week 8 | 62.5 (28.9 to 87.2) | 50.8 (20.9 to 80.1) |
| Week 12 | 64.9 (29.8 to 89.0) | 64.8 (28.6 to 89.4) |
Samples for serum PF-06687234 concentration were collected approximately 30 minutes prior to dosing. Concentration values below the lower limit of quantification were excluded when calculating the geometric mean (geometric coefficient of variation).
| ng/mL | PF-06687234 20 mg + Infliximab |
|---|---|
| Week 3 | 0.4537 ± 42 |
| Week 7 | 0.4494 ± 27 |
| Week 11 | 0.4713 ± 2 |
| Week 12 | 0.5140 ± 40 |
Plasma samples were analyzed for anti PF-06687234, anti PF-06687234 IL-10 neutralizing antibody (AB) and anti PF-06687234 single chain variable fragment (scFv) neutralizing AB. Samples inadvertently analyzed were excluded.
| Percentage of participants (%) | PF-06687234 20 mg + Infliximab |
|---|---|
| Anti PF-06687234 (Screening) | 0 |
| Anti PF-06687234 (Day 1) | 10.0 |
| Anti PF-06687234 (Week 3) | 30.0 |
| Anti PF-06687234 (Week 7) | 50.0 |
| Anti PF-06687234 (Week 11) | 28.6 |
| Anti PF-06687234 (Week 12) | 28.6 |
| Anti PF-06687234 (Week 16) | 12.5 |
| Anti PF-06687234 IL-10 neutralizing AB (Day 1) | 0 |
| Anti PF-06687234 IL-10 neutralizing AB (Week 3) | 0 |
| Anti PF-06687234 IL-10 neutralizing AB (Week 7) | 0 |
| Anti PF-06687234 IL-10 neutralizing AB (Week 11) | 0 |
| Anti PF-06687234 IL-10 neutralizing AB (Week 12) | 0 |
| Anti PF-06687234 IL-10 neutralizing AB (Week 16) | 0 |
| Anti PF-06687234 scFv neutralizing AB (Dany 1) | 0 |
| Anti PF-06687234 scFv neutralizing AB (Week 3) | 0 |
| Anti PF-06687234 scFv neutralizing AB (Week 7) | 50.0 |
| Anti PF-06687234 scFv neutralizing AB (Week 11) | 0 |
| Anti PF-06687234 scFv neutralizing AB (Week 12) | 0 |
| Anti PF-06687234 scFv neutralizing AB (Week 16) | 0 |
Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment.
| Participants | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with AEs | 8 | 9 |
| Participants with SAEs | 1 | 0 |
| Participants with severe AEs | 2 | 0 |
| Participants discontinued from study due to AEs | 0 | 0 |
| Participants discontinued study drug due to AEs and continued study | 2 | 1 |
| Participants with temporary discontinuation due to AEs | 1 | 1 |
Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment. Treatment-related AEs were also determined by the investigator.
| Participants | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Participants with AEs | 1 | 7 |
| Participants with SAEs | 0 | 0 |
| Participants with severe AEs | 0 | 0 |
| Participants discontinued from study due to AEs | 0 | 0 |
| Participants discontinued study drug due to AEs and continued study | 1 | 0 |
| Participants with temporary discontinuation due to AEs | 0 | 0 |
The laboratory tests as defined in the protocol, including hematology, chemistry, urinalysis and other, were performed. Baseline was defined as the last measurement prior to first dosing (Day 1).
| Participants | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 0 | 2 |
| Hematocrit (%) < 0.8 x LLN | 0 | 2 |
| Erythrocytes (10^6/mm^3) < 0.8 x LLN | 0 | 2 |
| Reticulocytes (10^3/mm^3) > 1.5 x upper limit of normal (ULN) | 0 | 1 |
| Reticulocytes/Erythrocytes (%) > 1.5 x ULN | 0 | 1 |
| Leukocytes (10^3/mm^3) > 1.5 x ULN | 0 | 1 |
| Lymphocytes (10^3/mm^3) < 0.8 x LLN | 2 | 2 |
| Lymphocytes/Leukocytes (%) < 0.8 x LLN | 1 | 4 |
| Neutrophils (10^3/mm^3) < 0.8 x LLN | 1 | 0 |
| Neutrophils (10^3/mm^3) > 1.2 x ULN | 0 | 2 |
| Neutrophils/Leukocytes (%) < 0.8 x LLN | 0 | 1 |
| Neutrophils/Leukocytes (%) > 1.2 x ULN | 0 | 2 |
| Basophils/Leukocytes (%) > 1.2 x ULN | 1 | 0 |
| Eosinophils (10^3/mm^3) > 1.2 x ULN | 0 | 1 |
| Eosinophils/Leukocytes (%) > 1.2 x ULN | 1 | 0 |
| Monocytes/Leukocytes (%) > 1.2 x ULN | 2 | 2 |
| Protein (g/dL) < 0.8 x LLN | 0 | 1 |
| Albumin (g/dL) < 0.8 x LLN | 1 | 1 |
| Creatinine (mg/dL) > 1.3 x ULN | 0 | 1 |
| Glucose (mg/dL) > 1.5 x ULN | 0 | 1 |
| Ketones (Scalar) >= 1 | 1 | 1 |
| Urine Protein (mg/dL) >= 1 | 1 | 1 |
| Urine Hemoglobin (Scalar) >= 1 | 3 | 3 |
| Leukocyte Esterase (Scalar) >= 1 | 4 | 3 |
| Hyaline Casts (/low-power field [LPF]) > 1 | 0 | 2 |
Single sitting blood pressure (BP), pulse rate, and temperature were measured. At Day 1 and Week 1, BP and pulse were collected approximately 30 minutes prior to dosing, approximately 30 minutes post dosing and approximately 1 hour post dosing. For participants with no safety issues (eg, severe injection site reactions, severe elevations BP and/or pulse), BP and pulse were collected approximately 30 minutes prior to dosing and approximately 30 minutes post dosing from Weeks 2-16. Vital signs were analyzed as per pre-specified categories.
| Participants | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Sitting systolic blood pressure (SBP) < 90 mmHg | 0 | 0 |
| Increase in Sitting SBP >=30 mmHg | 2 | 0 |
| Decrease in Sitting SBP >=30 mmHg | 0 | 0 |
| Sitting diastolic blood pressure (DBP) < 50 mmHg | 0 | 0 |
| Increase in Sitting DBP >=20 mmHg | 2 | 2 |
| Decrease in Sitting DBP >=20 mmHg | 3 | 2 |
| Sitting Pulse Rate < 40 beats/minute | 0 | 0 |
| Sitting Pulse Rate > 120 beats/minute | 0 | 0 |
Twelve (12) lead ECGs were collected. All scheduled ECGs were performed after the participants had rested quietly for at least 10 minutes in a supine position. When the timing of these measurements coincided with a blood collection, the ECG was obtained prior to the nominal time of the blood collection, blood pressure, and pulse rate. ECG data were analyzed as per pre-specified categories. PR=pulse rate; QTc=QT interval corrected for heart rate; QTcF=QTc corrected using Fridericia's formula.
| Participants | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| PR Interval >=300 millisecond (msec) | 0 | 0 |
| Change in PR Interval (%) >=25/50% | 0 | 0 |
| QRS Complex >=140 msec | 0 | 0 |
| Change in QRS Complex (%) >=50% | 0 | 0 |
| QT Interval >=500 msec | 0 | 0 |
| 450 msec ≤ QTcF < 480 msec | 0 | 0 |
| 480 msec <= QTcF < 500 msec | 0 | 0 |
| QTcF >=500 msec | 0 | 0 |
| 30 msec <= change in QTcF < 60 msec | 0 | 1 |
| Change in QTcF >=60 msec | 0 | 0 |
Collected over From the time the participant provided informed consent through Week 22.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Infliximab | 0/10 (0%) | 1/10 (10%) | 7/10 (70%) |
| PF-06687234 20 mg + Infliximab | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Event | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Colitis ulcerativeGastrointestinal disorders | 1/10 | 0/10 |
| Event | Placebo + Infliximab | PF-06687234 20 mg + Infliximab |
|---|---|---|
| Injection site reactionGeneral disorders | 0/10 | 3/10 |
| Colitis ulcerativeGastrointestinal disorders | 2/10 | 0/10 |
| Chest painGeneral disorders | 0/10 | 2/10 |
| Upper respiratory tract infectionInfections and infestations | 1/10 | 2/10 |
| HeadacheNervous system disorders | 2/10 | 2/10 |
| AnaemiaBlood and lymphatic system disorders | 0/10 | 1/10 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/10 | 1/10 |
| Abdominal distensionGastrointestinal disorders | 0/10 | 1/10 |
| Abdominal pain lowerGastrointestinal disorders | 1/10 | 0/10 |
| DyspepsiaGastrointestinal disorders | 0/10 | 1/10 |
All participants who received at least one dose of randomized treatment were included in the baseline analysis population.
| Age, Continuous(Years) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab | Total |
|---|---|---|---|
| Mean | 44.6 ± 21.11 | 44.5 ± 12.44 | 44.6 ± 16.86 |
| Age, Continuous(Years) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab | Total |
|---|---|---|---|
| Median | 44.5 (20 to 73) | 43.5 (20 to 64) | 43.5 (20 to 73) |
| Age, Customized(Participants) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab | Total |
|---|---|---|---|
| 18-44 Years | 5 | 6 | 11 |
| 45-64 Years | 2 | 4 | 6 |
| ≥ 65 Years | 3 | 0 | 3 |
| Sex: Female, Male(Participants) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 7 | 6 | 13 |
| Race/Ethnicity, Customized(Participants) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab | Total |
|---|---|---|---|
| White | 8 | 8 | 16 |
| Asian | 2 | 2 | 4 |
| Race/Ethnicity, Customized(Participants) | Placebo + Infliximab | PF-06687234 20 mg + Infliximab | Total |
|---|---|---|---|
| Not Hispanic or Latino | 10 | 10 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
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.
Data sharing details ↗ · www.pfizer.com
Ran from Dec 2017 to primary completion in Jan 2021, 36 months.
Results were first posted in Dec 2021, 11 months after primary completion.
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Studies of the drug tested here: PF-06687234