A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
Purpose
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
Condition
- Moderate to Severe Ulcerative Colitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- - A diagnosis of UC for ≥3 months. - Participants with moderate to severe active UC as defined by a Total Mayo Score of ≥6, and an endoscopic subscore of ≥2. - Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy). - Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.
Exclusion Criteria
- Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.). - Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study - Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available. - 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results - Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection. - Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
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 Cohort 1 |
Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W |
|
|
Experimental Cohort 2 |
Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W |
|
|
Experimental Cohort 3 |
Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W |
|
|
Placebo Comparator Cohort 4 |
Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W |
|
|
Experimental Cohort 5 |
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W |
|
|
Experimental Cohort 6 |
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W |
|
|
Experimental Cohort 7 |
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W |
|
|
Experimental Cohort 8 |
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W |
|
|
Experimental Cohort 9 |
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W |
|
More Details
- Status
- Completed
- Sponsor
- Hoffmann-La Roche