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

Phase 2

Withdrawn

• Conditions: Crohn Disease
• Interventions: Drug: Investigational Product; Drug: Placebo

• Registration Number: NCT05471492
• Lead Sponsor: Telavant, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Study Start: 2023-07-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19
• Primary Completion: 2026-08-15
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Investigational Product	PF-06480605 150 mg
Treatment Group 2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Proportion of participants with endoscopic response 50	Week 14	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission	Week 14	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.
Proportion of participants achieving endoscopic remission	Week 52	Endoscopic remission is defined as SES-CD \< 4 and at least 2-point reduction versus Baseline and no individual subscore \> 1
Proportion of participants achieving endoscopic mucosal healing	Week 52	Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD
The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170	Week 14	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.
Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.	up to week 52
Incidence of development of severe and serious infections	Up to week 52
Proportion of participants achieving endoscopic response	Week 52	Endoscopic response defined as improvement of SES-CD score at least 50% from baseline
Proportion of participants with a CDAI clinical remission	up to week 52	CDAI \< 150 overtime during induction treatment period
Proportion of participants with a CDAI clinical response	Up to week 52	As defined by a decrease from baseline in CDAI score of at least 100 points or more
Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response	Up to week 52	PRO2 clinical response is define by improvement in number of liquid/soft stool frequency and abdominal pain score at least 30% from baseline
Proportion of participants achieving PRO2 clinical remission	Up to week 52	PRO2 clinical remission is defined as SF≤2.5 and AP≤1