Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Pfizer
Conditions:
Moderate to Severe Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04090411
Start Date
December 19 2019
End Date
October 25 2022
Last Update
December 16 2025
Active Locations (166)
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1
Digestive Health Specialists
Dothan, Alabama, United States, 36301
2
Dothan Surgery Center
Dothan, Alabama, United States, 36301
3
Flowers Hospital
Dothan, Alabama, United States, 36305
4
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72204