A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

• Status: Active, not recruiting
• Trial end date: 2022-10-26
• Target enrollment: 0
• Participant gender: All

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 active therapy for 40 weeks, followed by a 12 week follow up period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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