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

NCT05471492 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: B75410092022-001259-18
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Crohn Disease

Keywords

Crohn Disease, PF-06480605, SES-CD, CDAI,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

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

  Week 14

• Proportion of participants achieving endoscopic remission

  Week 14

• Proportion of participants achieving endoscopic mucosal healing

  Week 14

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

  Week 14

• Proportion of participants achieving endoscopic response

  Week 52

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

PF-06480605 150 mg

Drug: Investigational Product

Treatment Group 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Investigational Product DRUG

PF-06480605 150 mg

Treatment Group 1

Placebo DRUG

Placebo

Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Telavant, Inc.: lead
• Pfizer: collaborator

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Crohn Disease; Anemia, Dyserythropoietic, Congenital

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 22, 2022
• Study Start: July 30, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share