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

NCT04090411

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Moderate to Severe Ulcerative Colitis

Interventions: Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W, Induction- PF-06480605 450 mg SC Q4W, Induction- Placebo SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

Countries: United States, Australia, Belgium, Bulgaria, Colombia, France, Germany, Hungary

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (166)
  • Dothan, Alabama, United States
  • Dothan, Alabama, United States
  • Dothan, Alabama, United States
  • Little Rock, Arkansas, United States
  • Newport Beach, California, United States
  • Guilford, Connecticut, United States
  • Hamden, Connecticut, United States
  • Hamden, Connecticut, United States
  • Hamden, Connecticut, United States
  • Hamden, Connecticut, United States
  • Brooksville, Florida, United States
  • Clearwater, Florida, United States
  • Clearwater, Florida, United States
  • Oldsmar, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Roswell, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Farmington Hills, Michigan, United States
  • Las Vegas, Nevada, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • + 136 more on CT.gov