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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 : Recruiting
First Posted : January 18, 2023
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
Ventyx Biosciences, Inc

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: VTX958 Drug: VTX958 Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
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
Official Title: 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
Actual Study Start Date : December 22, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: VTX958 Dose A Drug: VTX958
Dose A VTX958

Experimental: VTX958 Dose B Drug: VTX958
Dose B VTX958

Placebo Comparator: VTX958 Placebo Drug: VTX958 Placebo
Placebo




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05688852


Contacts
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Contact: Ventyx Clinical Trial Contact 888-411-5176 ext 108 ClinicalTrials@ventyxbio.com

Locations
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Sponsors and Collaborators
Ventyx Biosciences, Inc
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Responsible Party: Ventyx Biosciences, Inc
ClinicalTrials.gov Identifier: NCT05688852    
Other Study ID Numbers: VTX958-202
First Posted: January 18, 2023    Key Record Dates
Last Update Posted: February 23, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ventyx Biosciences, Inc:
VTX958
Harmony
Crohn's disease
TYK2
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases