At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE
In Brief
A Phase 2 clinical trial evaluating PF-06651600 Placebo, PF-06651600, and 2 other interventions for Crohn's Disease. Completed, enrolled 244 participants across 195 sites in 26 countries.
Detailed Summary
The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.
Study Details
Timeline
Interventions
12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks
200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks
12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks
60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks