Trial Outcomes & Findings for Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. (NCT NCT03269695)
NCT ID: NCT03269695
Last Updated: 2021-12-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Week 12
Results posted on
2021-12-28
Participant Flow
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.
Participants with active histologic Ulcerative Colitis (as defined by a total Mayo Score \>= 4 but \<=9 and an endoscopic subscore \>=2) for \>=4 months, and on a stable dose 5 to 10 mg/kg of Remicade, or protocol specified infliximab biosimilars for a minimum of 14 weeks prior to study entry with no anticipation of need for change in infliximab treatment regimen throughout the study were enrolled.
Participant milestones
| Measure |
Placebo + Infliximab
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Treated
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Placebo + Infliximab
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.
Baseline characteristics by cohort
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 Years
n=5 Participants
|
43.5 Years
n=7 Participants
|
43.5 Years
n=5 Participants
|
|
Age, Customized
18-44 Years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
45-64 Years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 Years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Endoscopic Subscore <=1, Observed Cases)
Participants with missing data
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for the composite primary endpoint.
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for the composite primary endpoint.
|
|
Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Endoscopic Subscore <=1, Observed Cases)
Participants with observed data
|
12.5 Percentage of participants (%)
Interval 0.6 to 50.0
|
14.3 Percentage of participants (%)
Interval 0.7 to 55.0
|
PRIMARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Mayo Endoscopic Subscore <=1, Treatment Failure Approach)
|
10 Percentage of participants (%)
Interval 0.5 to 44.4
|
10 Percentage of participants (%)
Interval 0.5 to 44.4
|
PRIMARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Observed Cases)
Participants with missing data
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for the composite primary endpoint.
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for the composite primary endpoint.
|
|
Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Observed Cases)
Participants with observed data
|
0 Percentage of participants (%)
Interval 0.0 to 34.9
|
14.3 Percentage of participants (%)
Interval 0.7 to 55.4
|
PRIMARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Treatment Failure Approach)
|
0 Percentage of participants (%)
Interval 0.0 to 26.7
|
10 Percentage of participants (%)
Interval 0.5 to 44.4
|
PRIMARY outcome
Timeframe: Baseline (Day 1) through and including a minimum of 28 calendar days after the last administration of the investigational products (22 weeks in total)Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Participants with AEs
|
8 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Participants with SAEs
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Participants with severe AEs
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Participants discontinued from study due to AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Participants discontinued study drug due to AEs and continued study
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Participants with temporary discontinuation due to AEs
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) through and including a minimum of 28 calendar days after the last administration of the investigational products (22 weeks in total)Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Participants with AEs
|
1 Participants
|
7 Participants
|
|
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Participants with SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Participants with severe AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Participants discontinued from study due to AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Participants discontinued study drug due to AEs and continued study
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Participants with temporary discontinuation due to AEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline through Week 16Population: All participants with at least one observation of the given laboratory test while on study treatment or during lag time (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Hematocrit (%) < 0.8 x LLN
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Erythrocytes (10^6/mm^3) < 0.8 x LLN
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Reticulocytes (10^3/mm^3) > 1.5 x upper limit of normal (ULN)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Reticulocytes/Erythrocytes (%) > 1.5 x ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Leukocytes (10^3/mm^3) > 1.5 x ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Lymphocytes (10^3/mm^3) < 0.8 x LLN
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Lymphocytes/Leukocytes (%) < 0.8 x LLN
|
1 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Neutrophils (10^3/mm^3) < 0.8 x LLN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Neutrophils (10^3/mm^3) > 1.2 x ULN
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Neutrophils/Leukocytes (%) < 0.8 x LLN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Neutrophils/Leukocytes (%) > 1.2 x ULN
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Basophils/Leukocytes (%) > 1.2 x ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Eosinophils (10^3/mm^3) > 1.2 x ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Eosinophils/Leukocytes (%) > 1.2 x ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Monocytes/Leukocytes (%) > 1.2 x ULN
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Protein (g/dL) < 0.8 x LLN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Albumin (g/dL) < 0.8 x LLN
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Creatinine (mg/dL) > 1.3 x ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Glucose (mg/dL) > 1.5 x ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Ketones (Scalar) >= 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Urine Protein (mg/dL) >= 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Urine Hemoglobin (Scalar) >= 1
|
3 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Leukocyte Esterase (Scalar) >= 1
|
4 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Hyaline Casts (/low-power field [LPF]) > 1
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From baseline through Week 16Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Number of Participants With Categorical Vital Signs
Sitting systolic blood pressure (SBP) < 90 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs
Increase in Sitting SBP >=30 mmHg
|
2 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs
Decrease in Sitting SBP >=30 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs
Sitting diastolic blood pressure (DBP) < 50 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs
Increase in Sitting DBP >=20 mmHg
|
2 Participants
|
2 Participants
|
|
Number of Participants With Categorical Vital Signs
Decrease in Sitting DBP >=20 mmHg
|
3 Participants
|
2 Participants
|
|
Number of Participants With Categorical Vital Signs
Sitting Pulse Rate < 40 beats/minute
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs
Sitting Pulse Rate > 120 beats/minute
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline through Week 16Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
PR Interval >=300 millisecond (msec)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
Change in PR Interval (%) >=25/50%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
QRS Complex >=140 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
Change in QRS Complex (%) >=50%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
QT Interval >=500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
450 msec ≤ QTcF < 480 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
480 msec <= QTcF < 500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
QTcF >=500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
30 msec <= change in QTcF < 60 msec
|
0 Participants
|
1 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG) Data
Change in QTcF >=60 msec
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Improvement at Week 12 ( Observed Cases)
Participants with missing data
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for this secondary endpoint.
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for this secondary endpoint.
|
|
Percentage of Participants With Endoscopic Improvement at Week 12 ( Observed Cases)
Participants with observed data
|
25.0 Percentage of participants (%)
Interval 4.6 to 65.1
|
57.1 Percentage of participants (%)
Interval 22.5 to 87.1
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Improvement at Week 12 ( Treatment Failure Approach)
|
20.0 Percentage of participants (%)
Interval 3.7 to 55.6
|
40.0 Percentage of participants (%)
Interval 15.0 to 73.3
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Geboes Index Remission at Week 12 (Observed Cases)
Participants with missing data
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for this secondary endpoint.
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for this secondary endpoint.
|
|
Percentage of Participants Achieving Geboes Index Remission at Week 12 (Observed Cases)
Participant with observed data
|
62.5 Percentage of participants (%)
Interval 28.9 to 88.9
|
37.5 Percentage of participants (%)
Interval 11.1 to 71.1
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who had received at least one dose of the randomized treatment (10 each for the Placebo + Infliximab arm and the PF-06687234 20mg + Infliximab arm).
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Change From Baseline in Robart's Histology Index at Week 12 (Observed Cases)
Participants with missing data
|
NA Scores on a scale
These participants did not have observed endoscopic data for this secondary endpoint.
|
NA Scores on a scale
These participants did not have observed endoscopic data for this secondary endpoint.
|
|
Change From Baseline in Robart's Histology Index at Week 12 (Observed Cases)
Participants with observed data
|
-12.96 Scores on a scale
Interval -20.6 to -5.32
|
-7.16 Scores on a scale
Interval -14.81 to 0.48
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have received at least one dose of the randomized treatment. The number of participants with observed data were 8 for the Placebo + Infliximab arm and 7 for PF-06687234 20mg + Infliximab arm. The percentage of participants achieving clinical response was calculated based on the number of participants with observed data.
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants With a Clinical Response at Week 12 (Observed Cases)
Participants with missing data
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for this secondary endpoint.
|
NA Percentage of participants (%)
These participants did not have observed endoscopic data for this secondary endpoint.
|
|
Percentage of Participants With a Clinical Response at Week 12 (Observed Cases)
Participants with observed data
|
37.5 Percentage of participants (%)
Interval 11.1 to 71.1
|
85.7 Percentage of participants (%)
Interval 44.6 to 99.3
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have received at least one dose of the randomized treatment.
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants With a Clinical Response at Week 12 (Treatment Failure Approach)
|
30.0 Percentage of participants (%)
Interval 8.7 to 61.9
|
60.0 Percentage of participants (%)
Interval 26.7 to 85.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: All participants who have received at least one dose of the randomized treatment.
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 Participants
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
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)
Week 2
|
50.0 Percentage of participants (%)
Interval 21.0 to 79.0
|
50.0 Percentage of participants (%)
Interval 21.0 to 79.0
|
|
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)
Week 4
|
50.0 Percentage of participants (%)
Interval 21.0 to 79.0
|
60.0 Percentage of participants (%)
Interval 27.9 to 85.3
|
|
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)
Week 8
|
62.5 Percentage of participants (%)
Interval 28.9 to 87.2
|
50.8 Percentage of participants (%)
Interval 20.9 to 80.1
|
|
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)
Week 12
|
64.9 Percentage of participants (%)
Interval 29.8 to 89.0
|
64.8 Percentage of participants (%)
Interval 28.6 to 89.4
|
SECONDARY outcome
Timeframe: Prior to dosing on Day 1 and at Weeks 1, 3, 7, 11, 12 (168 hours post dose) and 16Population: All participants who received at least one dose of PF-06687234, had data on at least one PK concentration (above or equal to lower limit of quantification) and did not participate in PK substudy.
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).
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Serum Concentrations of PF-06687234 20 mg
Week 3
|
0.4537 ng/mL
Geometric Coefficient of Variation 42
|
—
|
|
Serum Concentrations of PF-06687234 20 mg
Week 7
|
0.4494 ng/mL
Geometric Coefficient of Variation 27
|
—
|
|
Serum Concentrations of PF-06687234 20 mg
Week 11
|
0.4713 ng/mL
Geometric Coefficient of Variation 2
|
—
|
|
Serum Concentrations of PF-06687234 20 mg
Week 12
|
0.5140 ng/mL
Geometric Coefficient of Variation 40
|
—
|
SECONDARY outcome
Timeframe: At screening, Day 1, Weeks 3, 7, 11, 12 and 16 (prior to dosing)Population: HAFA and NAb analyses were performed to characterize immunogenicity against PF-06687234, hence only participants who received at least one dose of PF-06687234 and with at least one post treatment HAFA determination were included.
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.
Outcome measures
| Measure |
Placebo + Infliximab
n=10 Participants
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 (Screening)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 (Day 1)
|
10.0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 (Week 3)
|
30.0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 (Week 7)
|
50.0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 (Week 11)
|
28.6 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 (Week 12)
|
28.6 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 (Week 16)
|
12.5 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 IL-10 neutralizing AB (Day 1)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 IL-10 neutralizing AB (Week 3)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 IL-10 neutralizing AB (Week 7)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 IL-10 neutralizing AB (Week 11)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 IL-10 neutralizing AB (Week 12)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 IL-10 neutralizing AB (Week 16)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 scFv neutralizing AB (Dany 1)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 scFv neutralizing AB (Week 3)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 scFv neutralizing AB (Week 7)
|
50.0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 scFv neutralizing AB (Week 11)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 scFv neutralizing AB (Week 12)
|
0 Percentage of participants (%)
|
—
|
|
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Anti PF-06687234 scFv neutralizing AB (Week 16)
|
0 Percentage of participants (%)
|
—
|
Adverse Events
Placebo + Infliximab
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06687234 20 mg + Infliximab
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Infliximab
n=10 participants at risk
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 participants at risk
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
Other adverse events
| Measure |
Placebo + Infliximab
n=10 participants at risk
Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
PF-06687234 20 mg + Infliximab
n=10 participants at risk
PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
20.0%
2/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Gastrointestinal disorders
Glossitis
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
General disorders
Chest pain
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
20.0%
2/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
General disorders
Fatigue
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
30.0%
3/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
General disorders
Oedema
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
General disorders
Xerosis
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
General disorders
Injection site rash
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Infections and infestations
Onychomycosis
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
20.0%
2/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Investigations
Cardiac murmur
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
20.0%
2/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Psychiatric disorders
Stress
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
10.0%
1/10 • From the time the participant provided informed consent through Week 22.
All participants who received at least one dose of randomized treatment were included in the analysis for AEs and SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER