A Study of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

Phase 2

• Conditions: Health Condition 1: K515- Left sided colitisHealth Condition 2: K510- Ulcerative (chronic) pancolitisHealth Condition 3: K512- Ulcerative (chronic) proctitisHealth Condition 4: K513- Ulcerative (chronic) rectosigmoiditis

• Registration Number: CTRI/2020/07/026827
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

(1) A diagnosis of UC for >=3 months.

(2)Participants with moderate to severe active UC as defined by a Total Mayo Score of >=6, and an endoscopic subscore of >=2.

(3)Active disease beyond the rectum ( >15 cm of active disease from the anal verge at the screening endoscopy).

(4)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

(1)Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohns disease (eg, skip lesions, fistulae or perianal disease, non necrotizing granulomas, etc.).

(2)Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study

(3) Chest Radiograph showing abnormalities i.e. 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.

(4)12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results

(5)Infected with tuberculosis i.e. any evidence of untreated latent or active TB infection.

(6)Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

Study & Design

• Study Type: Interventional
• Study Design: Not specified