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

Telavant, Inc.

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Crohn Disease

Interventions

Investigational ProductDRUG

PF-06480605 150 mg

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of participants with endoscopic response 50

Endoscopy response 50 (SES-CD50) is defined as a reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at least 50% or more. SES-CD score assesses the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing using scales ranging from 0 to 3 in each following bowel segment: Ileum, right colon, transverse colon, left colon, rectum. The score ranges from 0 to 60 with higher score indicating more severe disease.

Time frame: Week 14

Secondary Outcomes

Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission

Clinical remission is defined as CDAI \< 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Time frame: Week 14

Proportion of participants achieving endoscopic remission

Endoscopic remission is defined as SES-CD \< 4 and at least 2-point reduction versus Baseline and no individual subscore \> 1

Time frame: Week 14

Proportion of participants achieving endoscopic mucosal healing

Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD

Time frame: Week 14

The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170

Inflammatory Bowel Disease Questionnaire (IBDQ) score ranges from 32 to 224. A higher score indicates better quality of life. A score of at least 170 corresponds to clinical remission.

Data from ClinicalTrials.gov

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