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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2026-08-15

Brief Summary

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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

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Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of two groups in parallel for the duration of the study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group 1

PF-06480605 150 mg

Group Type EXPERIMENTAL

Investigational Product

Intervention Type DRUG

PF-06480605 150 mg

Treatment Group 2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Investigational Product

PF-06480605 150 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No