Purpose of this study?
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.
Key Inclusion Criteria ( - Prescreening):
- Diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months from baseline
- Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD (steroids, immunomodulators, biologics)
- Whashout period for different medications – IFX, ADA etc. anti-TNF = 8 weeks; AZA, 6MP, MTX = 2 weeks; topical steroids = 2 weeks; other biologics, immunosuppressants, JAKI = 3 months; other investigational drugs = 30 Days of 5 half lives (longer of the 2)
- Stable dose of steroids (≤ 25 mg prednisone) 2 weeks; 5 ASA 4 weeks.
Key Exclusion Criteria ( - Prescreening):
- Any other colitis (not CD) – indeterminate, UC, infectious etc.
- Draining fistula, short bowel, stricture, stoma, surgery within 6 months, perforation within 12 months
- Prohibited concomitant meds
- Colonic adenomas, dysplasia or neoplasia. Those with prior history of adenomatous polyps or any adenomatous polyps identified on screening will be eligible if the polyps have been completely removed
- Cancer, lymphoproliferative disorders (5 years); transplant recipient
- Active infection; serious infections (6 months); disseminated herpes zoster or disseminated herpes simpley; Hep B/C, HIV, TB
- Major organ system illness/unstable condition
- History of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability
Protocol Amendment 5 Changes
Protocol updated to eliminate the PF-06700841 (brepocitinib) active and corresponding (brepocitinib) placebo arms. This is a strategic decision on the part of the sponsor to prioritize future development of PF-06651600 (ritlecitinib)
- The decision to eliminate the PF‑06700841 (brepocitinib) cohort from this study B7981007 is not due to any specific safety, efficacy or quality concerns that would negatively affect the overall benefit/risk for patients in this trial or in other trials.
- Protocol updated to change the primary endpoint during induction from CMEI to SES‑CD 50, to enable efficient comparison with contemporary and emerging trials in Crohn’s disease.
Study Locations in Europe:
Austria, Belgium, Bosnia-Herzegovina, Croatia, Czech Republic, Georgia, Germany, Hungary, Italy, Poland, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Ukraine
Estimated Study Completion Date:
March 28, 2024
Further information on clinicaltrials.gov - trial number
NCT03395184