Phase 2
Completed N=317
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
Source: ClinicalTrials.gov NCT02958865 ↗Enrolled (actual)
317
Serious AEs
4.0%
Results posted
Jul 2022
Primary outcomePrimary: Total Mayo Score at Week 8 (Induction Period) — 7.88; 5.85; 4.00; 3.27 Units on a scale — p=0.0017
Summary
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Mayo Score at Week 8 (Induction Period) |
7.88; 5.85; 4.00; 3.27; 6.08; 5.60 | 0.0017 sig |
| SECONDARY Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) |
18; 27; 18; 8; 21; 23 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities (Chronic Period) |
27; 31; 33; 8; 29; 27 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) |
2; 2; 1; 1; 3; 3 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Data (Chronic Period) |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal ECG Findings (Chronic Period) |
3; 6; 2; 1; 1; 2 | — |
| SECONDARY Number of Participants With Serious Infections (Chronic Period) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) |
13; 23; 21; 21; 19; 26 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities (Induction Period) |
17; 29; 28; 34; 32; 31 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) |
3; 2; 5; 9; 4; 4 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) |
0; 1; 0; 1; 2; 2 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Data (Induction Period) |
0; 1; 1; 0; 3; 0 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) |
2; 8; 6; 4; 9; 10 | — |
| SECONDARY Number of Participants With Serious Infections (Induction Period) |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) |
0; 9.8; 28.6; 34.0; 8.3; 23.4 | 0.0626 |
| SECONDARY Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) |
0; 21.6; 34.7; 42.0; 20.8; 31.9 | 0.0111 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) |
24.0; 41.2; 69.4; 68.0; 41.7; 53.2 | 0.0788 |
| SECONDARY Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) |
0; 3.9; 8.2; 12.0; 2.1; 17.0 | 0.2259 |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) |
0; 7.8; 16.3; 26.0; 6.3; 14.9 | 0.0872 |
| SECONDARY Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) |
0; 3.9; 8.2; 12.0; 0; 14.9 | 0.2259 |
| SECONDARY Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) |
-0.66; -1.65; -2.56; -3.19; -1.6; -1.64 | — |
| SECONDARY Change From Baseline in Total Mayo Score at Week 8 (Induction Period) |
-1.14; -3.17; -5.02; -5.74; -2.93; -3.42 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) |
35.80; 34.29; 33.71; 34.84; 34.17; 32.38 | — |
| SECONDARY Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) |
30.30; 33.71; 51.12; 57.01; 28.45; 37.94 | — |
| SECONDARY Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) |
24.0; 21.6; 40.8; 46.0; 27.1; 27.7 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) |
48.0; 60.8; 83.7; 80.0; 64.6; 78.7 | — |
| SECONDARY Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) |
20.0; 51.0; 65.3; 64.0; 37.5; 53.2 | — |
| SECONDARY Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) |
4.69; 5.90; 6.36; 9.21; 5.67; 5.85 | — |
| SECONDARY Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) |
0.11; 0.07; 0.12; 0.13; 0.07; 0.11 | — |
| SECONDARY Total Mayo Score at Week 32 (Chronic Period) |
4.13; 3.47; 3.46; 2.89; 4.62; 3.81 | — |
| SECONDARY Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) |
16.7; 23.9; 28.6; 34.1; 18.2; 21.4 | — |
| SECONDARY Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) |
33.3; 26.1; 40.5; 34.1; 18.2; 31.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ulcerative colitis for greater than/equal to 3 months.
- Moderate to severe active ulcerative colitis
- Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
Exclusion Criteria
- Pregnant or breastfeeding
- Clinical findings suggestive of Crohn's Disease
- History of bowel surgery within 6 months
Data sourced from ClinicalTrials.gov (NCT02958865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.