Clinical Trial

Treatment Efficacy for Mod-Severe Crohn's Disease

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Placebo PF-06651600

12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks

Drug - Placebo PF-06700841

12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.

Drug - PF-06651600

200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks

Drug - PF-06700841

60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03395184

ParticipAid ID

Pe908d