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

Crohn Disease Clinical Trial

Official title:

A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL CHRONIC TREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE CROHN'S DISEASE

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05471492
• Other study ID #: B7541009
• Secondary ID: 2022-001259-18
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 30, 2023
• Est. completion date: August 15, 2026

Study information

• Verified date: October 2023
• Source: Telavant, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Investigational Product
PF-06480605 150 mg
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Telavant, Inc.	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 14
Secondary	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.	Week 14
Secondary	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	Week 14
Secondary	Proportion of participants achieving endoscopic mucosal healing	Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD	Week 14
Secondary	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.	Week 14
Secondary	Proportion of participants achieving endoscopic response	Endoscopic response defined as improvement of SES-CD score at least 50% from baseline	Week 52
Secondary	Proportion of participants with a 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.	Week 52
Secondary	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	Week 52
Secondary	Proportion of participants achieving endoscopic mucosal healing	Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD	Week 52
Secondary	Proportion of participants with a CDAI clinical remission	CDAI < 150 overtime during induction treatment period	up to week 52
Secondary	Proportion of participants with a CDAI clinical response	As defined by a decrease from baseline in CDAI score of at least 100 points or more	Up to week 52
Secondary	Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response	PRO2 clinical response is define by improvement in number of liquid/soft stool frequency and abdominal pain score at least 30% from baseline	Up to week 52
Secondary	Proportion of participants achieving PRO2 clinical remission	PRO2 clinical remission is defined as SF=2.5 and AP=1	Up to week 52
Secondary	Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.		up to week 52
Secondary	Incidence of development of severe and serious infections		Up to week 52

External Links

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