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

Telavant

Status and phase

Withdrawn

Phase 2

Conditions

Crohn Disease

Treatments

Drug: Placebo

Drug: Investigational Product

Study type

Interventional

Funder types

Industry

Identifiers

NCT05471492

B7541009

2022-001259-18 (EudraCT Number)

Details and patient eligibility

About

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.