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VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease (Harmony-CD)

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ClinicalTrials.gov Identifier: NCT05688852
Recruitment Status : Active, not recruiting
First Posted : January 18, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Ventyx Biosciences, Inc

Tracking Information
First Submitted Date  ICMJE January 5, 2023
First Posted Date  ICMJE January 18, 2023
Last Update Posted Date April 18, 2024
Actual Study Start Date  ICMJE December 22, 2022
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2023)
  • Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12 [ Time Frame: During screening to week 12 ]
    Change in Mean CDAI (Crohn's disease Activity Index). CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
  • The proportion of participants achieving endoscopic response at Week 12 [ Time Frame: During screening to week 12 ]
    SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2023)
  • Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12 [ Time Frame: During screening to week 12 ]
    Change from baseline in mean simple endoscopic score in Crohn's disease SED-CD at 12 weeks. The SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
  • Proportion of participants achieving clinical remission at Week 12 [ Time Frame: During screening to week 12 ]
    Clinical remission is defined as a CDAI score < 150. CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
  • Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12 [ Time Frame: During screening to week 12 ]
    The proportion of participants achieving PRO2 remission at week 12. PRO2 remission is defined is an unweighted CDAI component of daily AP score ≤ 1 and unweighted CDAI component of daily average stool frequency (SF) score ≤ 3
  • Proportion of participants achieving clinical response at Week 12 [ Time Frame: During screening to week 12 ]
    Proportion of participants achieving clinical response at Week 12. A clinical response is defined as ≥ 100 points reduction from baseline in CDAI score or CDAI score < 150. CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
  • Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12 [ Time Frame: During screening to week 12 ]
    Proportion of participants achieving both endoscopic response (as described in outcome measure 2) and clinical remission (as described in outcome measure 4) at Week 12.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
Official Title  ICMJE A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderately to Severely Active Crohn's Disease
Brief Summary This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease.
Detailed Description

This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease. Approximately 132 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of CD (yes/no).

The study consists of a 30-day Screening Period, a 12-week double-blind Induction Treatment Period, a 40-week double-blind Maintenance Treatment Period, an Open-Label Extension (OLE) of up to 144 weeks, and a 30-day safety Follow-Up Period. The maximum duration of treatment will be 36 months, including the Induction, Maintenance, and OLE Periods. For all participants, a Follow-Up visit will be performed at 30 days after the last dose of study drug.

Objectives Primary Objectives

* Evaluate the efficacy of VTX958 in achieving reduction in Crohn's Disease Activity Index (CDAI) score and endoscopic response at the end of the Induction Period

Secondary Objectives

  • Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response and remission at the end of the Induction Period
  • Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remission at the end of the Induction Period
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The study will employ a double-blind design. Participants, Investigators, study center staff, persons performing the assessments, and the Sponsor are to remain blinded to the identity of the Induction and Maintenance Period treatment from the time of randomization until the interim database lock for the study
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Drug: VTX958
    Dose A VTX958
  • Drug: VTX958
    Dose B VTX958
  • Drug: VTX958 Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: VTX958 Dose A
    Intervention: Drug: VTX958
  • Experimental: VTX958 Dose B
    Intervention: Drug: VTX958
  • Placebo Comparator: VTX958 Placebo
    Intervention: Drug: VTX958 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 17, 2023)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2027
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men or women, 18 to 75 years of age, inclusive, at the time of consent
  2. Capable of giving signed informed consent
  3. Documented diagnosis of CD ≥ 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.
  4. Moderately to severely active CD

Exclusion Criteria:

  1. Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
  2. Presence of a stoma or ileoanal pouch
  3. Presence of currently known complications of CD such as symptomatic bowel stricture(s) and >2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization
  4. Known diagnosis of short gut or bowel syndrome
  5. Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Bulgaria,   Canada,   Czechia,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Lithuania,   Moldova, Republic of,   Poland,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05688852
Other Study ID Numbers  ICMJE VTX958-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Ventyx Biosciences, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ventyx Biosciences, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ventyx Biosciences, Inc
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP