A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL CHRONIC TREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE CROHN'S DISEASE

B7541009

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity

2023-07-30

2026-08-15

2026-08-15

Withdrawn

Early phase I

Inclusion Criteria: * Confirmed diagnosis of ileocolonic or colonic CD with at least 3 months or longer prior to the baseline; * Central read total SES-CD score of ≥7. For isolated ileal disease, SES-CD total score should be ≥4; * An average daily liquid/very soft SF ≥4 or daily AP score ≥2.0; * CDAI between 220 and 450 inclusive; * Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, UC, or clinical findings suggestive of UC; * Presence of active (draining) fistulae or intra-abdominal or perineal abscesses; * Strictures or stenosis with obstructive symptoms; * Short bowel syndrome; * History of bowel perforation requiring surgical intervention within the past 12 months prior to baseline; * Previous bowel surgery resulting in an existing stoma. Participants who have a j-pouch are excluded, as a j-pouch can result in a stoma; * History of bowel surgery within 6 months prior to baseline.

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2023-10-19