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

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

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 Overview

• Status: Withdrawn
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Placebo; Drug: Investigational Product

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group 1; PF-06480605 150 mg	Drug: Investigational Product; PF-06480605 150 mg
Placebo Comparator: Treatment Group 2; Placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Proportion of participants achieving endoscopic mucosal healing	Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD	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.	Week 14
Proportion of participants achieving endoscopic response	Endoscopic response defined as improvement of SES-CD score at least 50% from baseline	Week 52
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
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
Proportion of participants achieving endoscopic mucosal healing	Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD	Week 52
Proportion of participants with a CDAI clinical remission	CDAI < 150 overtime during induction treatment period	up to week 52
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
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
Proportion of participants achieving PRO2 clinical remission	PRO2 clinical remission is defined as SF≤2.5 and AP≤1	Up to week 52
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

Collaborators and Investigators

• Sponsor: Telavant, Inc.
• Collaborators: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Crohn Disease, PF-06480605, SES-CD, CDAI,
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: B7541009; 2022-001259-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No