Overview

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