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

NCT04090411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-12-16

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2022-10-25
Completion
2022-10-25
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090411 on ClinicalTrials.gov