Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
Purpose
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.
Condition
- Ulcerative Colitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PF-06651600 Drug Dose Level 1 |
Delivered orally for 8 weeks |
|
|
Experimental PF-06651600 Drug Dose Level 2 |
Delivered orally for 8 weeks |
|
|
Experimental PF-06651600 Drug Dose Level 3 |
Delivered orally for 8 weeks. |
|
|
Placebo Comparator PF-06651600 Placebo |
Delivered orally for 8 weeks. |
|
|
Experimental PF-06700841 Drug Dose Level 1 |
Delivered orally for 8 weeks |
|
|
Experimental PF-06700841 Drug Dose Level 2 |
Delivered orally for 8 weeks. |
|
|
Experimental PF-06700841 Drug Dose Level 3 |
Delivered orally for 8 weeks. |
|
|
Placebo Comparator PF-06700841 Placebo |
Delivered orally for 8 weeks. |
|
|
Experimental PF-06651600 Drug Dose Level 4 |
Delivered orally for 24 weeks. |
|
|
Experimental PF-06700841 Drug Dose Level 4 |
Delivered orally for 24 weeks. |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer