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

WithdrawnPhase 2

Sponsor: Telavant, Inc.

Conditions: Crohn Disease

Interventions: Investigational Product, Placebo

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.