NCT04090411

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

A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate To Severe Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to Severe Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Induction- PF-06480605 50 mg SC Q4W	PF-06480605
DRUG	Induction- PF-06480605 150 mg SC Q4W	PF-06480605
DRUG	Induction- PF-06480605 450 mg SC Q4W	PF-06480605
OTHER	Induction- Placebo SC Q4W	0 mg Placebo
DRUG	Chronic- PF-06480605 50 mg SC Q4W	PF-06480605
DRUG	Chronic- PF-06480605 150 mg SC Q4W	PF-06480605
DRUG	Chronic- PF-06480605 450 mg SC Q4W	PF-06480605

Timeline

• Start date: 2019-12-19
• Primary completion: 2022-10-25
• Completion: 2022-10-25
• First posted: 2019-09-16
• Last updated: 2025-12-16
• Results posted: 2025-12-16

Locations

166 sites across 23 countries: United States, Australia, Belgium, Bulgaria, Colombia, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study