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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Withdrawn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
Telavant, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn Disease, PF-06480605, SES-CD, CDAI,

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 18, 2022
    Last Updated
    October 17, 2023
    Sponsor
    Telavant, Inc.
    Collaborators
    Pfizer
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    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
    To obtain contact information for a study center near you, click here.

    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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