Phase 2
N=357
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT01620255 ↗Enrolled (actual)
357
Serious AEs
6.7%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants in Clinical Remission at Week 12 — 2.7; 11.3; 16.7; 15.5 percentage of participants — p=0.0213
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); PF-00547659 SC Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Clinical Remission at Week 12 |
2.7; 11.3; 16.7; 15.5; 5.7; 5.5 | 0.0213 sig |
| SECONDARY Percentage of Participants With Clinical Response at Week 12 |
28.8; 38.0; 54.2; 45.1; 50.0; 32.9 | 0.1379 |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 12 |
8.2; 15.5; 27.8; 25.4; 14.3; 21.9 | 0.0618 |
| SECONDARY Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12 |
— | — |
| SECONDARY Change From Baseline in Total Mayo Score at Week 12 |
8.4; 8.7; 8.1; 8.4; 8.7; -1.5 | 0.0494 sig |
| SECONDARY Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 |
26.87; 46.88; 36.62; 30.43; 43.08; 59.70 | 0.1016 |
| SECONDARY Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 |
25.37; 28.57; 47.83; 47.76; 39.68; 61.19 | 0.5406 |
| SECONDARY Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 |
-25.62; -40.21; -23.50; -46.22; -39.27; -21.68 | 0.9744 |
| SECONDARY Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 |
-11.60; -19.17; -26.90; -35.21; -17.70; -2.42 | 0.9328 |
| SECONDARY Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 |
128.0; 122.1; 133.4; 128.0; 132.3; 19.8 | 0.8302 |
| SECONDARY Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 |
38.9; 37.0; 41.7; 38.5; 41.0; 7.4 | 0.6862 |
| SECONDARY Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12 |
36.9; 36.8; 55.6; 46.9; 48.1 | 0.5201 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) |
39; 41; 36; 43; 43; 4 | — |
| SECONDARY Maximum Serum PF-00547659 Concentration Achieved |
929.4; 2062; 6576; 21470 | — |
Summary
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
Eligibility Criteria
Inclusion Criteria
- Subjects with diagnosis of Ulcerative Colitis for 3 or more months.
- Ulcerative colitis must be active beyond the rectum.
- Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points
Exclusion Criteria
- Pregnant or breast feeding.
- Diagnosis of indeterminate colitis or Crohn's Disease
- Subjects with history of colonic or small bowel obstruction or resection.
Data sourced from ClinicalTrials.gov (NCT01620255). 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.