Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease

• Status: Not yet recruiting
• Trial end date: 2025-08-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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.