At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 246 enrolled
Drug / intervention
Induction- PF-06480605 50 mg SC Q4W +6 moredrug
Likely dose
Induction- PF-06480605 50 mg SC Q4Wfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W, and 5 other interventions for Moderate to Severe Ulcerative Colitis. Completed, enrolled 246 participants across 166 sites in 23 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate to Severe Ulcerative Colitis
CountriesAustralia, Belgium, Bulgaria, Colombia, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsPfizer
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartDec 2019
Primary CompletionOct 2022
TodayJul 2026
First PostedSep 16, 2019
Enrollment StartDec 19, 2019
Primary CompletionOct 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.8 years ago
Interventions
Induction- PF-06480605 50 mg SC Q4Wdrug
PF-06480605
Induction- PF-06480605 150 mg SC Q4Wdrug
PF-06480605
Induction- PF-06480605 450 mg SC Q4Wdrug
PF-06480605
Induction- Placebo SC Q4Wother
0 mg Placebo
Chronic- PF-06480605 50 mg SC Q4Wdrug
PF-06480605
Chronic- PF-06480605 150 mg SC Q4Wdrug
PF-06480605
Chronic- PF-06480605 450 mg SC Q4Wdrug
PF-06480605