Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
Primary Purpose
Crohn Disease
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Investigational Product
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn Disease, PF-06480605, SES-CD, CDAI,
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group 1
Treatment Group 2
Arm Description
PF-06480605 150 mg
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Proportion of participants achieving endoscopic mucosal healing
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
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.
Proportion of participants achieving endoscopic response
Endoscopic response defined as improvement of SES-CD score at least 50% from baseline
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.
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
Proportion of participants achieving endoscopic mucosal healing
Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD
Proportion of participants with a CDAI clinical remission
CDAI < 150 overtime during induction treatment period
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
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
Proportion of participants achieving PRO2 clinical remission
PRO2 clinical remission is defined as SF≤2.5 and AP≤1
Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.
Incidence of development of severe and serious infections
Full Information
NCT ID
NCT05471492
First Posted
July 18, 2022
Last Updated
October 17, 2023
Sponsor
Telavant, Inc.
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT05471492
Brief Title
Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Trial not started; change in Sponsor, a new trial to be registered by the new Sponsor
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
August 15, 2026 (Anticipated)
Study Completion Date
August 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telavant, Inc.
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn Disease, PF-06480605, SES-CD, CDAI,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups in parallel for the duration of the study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
PF-06480605 150 mg
Arm Title
Treatment Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Investigational Product
Intervention Description
PF-06480605 150 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Proportion of participants with endoscopic response 50
Description
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 Outcome Measure Information:
Title
Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission
Description
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
Title
Proportion of participants achieving endoscopic remission
Description
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
Title
Proportion of participants achieving endoscopic mucosal healing
Description
Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD
Time Frame
Week 14
Title
The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170
Description
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.
Time Frame
Week 14
Title
Proportion of participants achieving endoscopic response
Description
Endoscopic response defined as improvement of SES-CD score at least 50% from baseline
Time Frame
Week 52
Title
Proportion of participants with a CDAI clinical remission
Description
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 52
Title
Proportion of participants achieving endoscopic remission
Description
Endoscopic remission is defined as SES-CD < 4 and at least 2-point reduction versus Baseline and no individual subscore > 1
Time Frame
Week 52
Title
Proportion of participants achieving endoscopic mucosal healing
Description
Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD
Time Frame
Week 52
Title
Proportion of participants with a CDAI clinical remission
Description
CDAI < 150 overtime during induction treatment period
Time Frame
up to week 52
Title
Proportion of participants with a CDAI clinical response
Description
As defined by a decrease from baseline in CDAI score of at least 100 points or more
Time Frame
Up to week 52
Title
Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response
Description
PRO2 clinical response is define by improvement in number of liquid/soft stool frequency and abdominal pain score at least 30% from baseline
Time Frame
Up to week 52
Title
Proportion of participants achieving PRO2 clinical remission
Description
PRO2 clinical remission is defined as SF≤2.5 and AP≤1
Time Frame
Up to week 52
Title
Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.
Time Frame
up to week 52
Title
Incidence of development of severe and serious infections
Time Frame
Up to week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7541009
Description
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Learn more about this trial
Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
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