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

Completed · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT04090411

Run by

Hoffmann-La Roche

People needed

246

Starts

2019-12-19

Expected to finish

2022-10-25

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dothan Surgery Center — Dothan, Alabama, United States
• Flowers Hospital — Dothan, Alabama, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Surinder Saini, M.D., Inc. — Newport Beach, California, United States
• Endoscopy Center of Connecticut, LLC — Guilford, Connecticut, United States
• Endoscopy Center of Connecticut, LLC — Hamden, Connecticut, United States
• Medical Research Center Of Connecticut, LLC — Hamden, Connecticut, United States
• PACT Gastroenterology Center — Hamden, Connecticut, United States
• Whitney Imaging — Hamden, Connecticut, United States
• Medycal Research Inc. — Brooksville, Florida, United States
• Safety Harbor Surgery — Clearwater, Florida, United States
• Trident Care — Clearwater, Florida, United States
• Tower Radiology Center — Oldsmar, Florida, United States
• Akumin — Tampa, Florida, United States
• Tampa Bay Endoscopy Center — Tampa, Florida, United States
• Alliance Clinical Research of Tampa — Tampa, Florida, United States
• Gastroenterology Consultants P.C. — Roswell, Georgia, United States
• The University of Chicago Medical Center (clinic address) — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital - Office — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Michigan Endoscopy Center — Farmington Hills, Michigan, United States
• Digestive Health Specialists — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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