NCT03395184

Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	PF-06651600 Placebo	12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks
DRUG	PF-06651600	200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks
DRUG	Placebo PF-06700841	12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks
DRUG	PF-06700841	60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks

Timeline

• Start date: 2018-02-02
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2018-01-10
• Last updated: 2024-10-30
• Results posted: 2024-10-30

Locations

195 sites across 26 countries: United States, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czechia, Georgia, Germany, Hungary, Italy, Lebanon, Poland, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey (Türkiye), Ukraine, United Arab Emirates

Regulatory

• FDA-regulated drug study