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

Ventyx Biosciences

Status and phase: Terminated; Phase 2

Conditions: Crohn Disease

Treatments: Drug: VTX958; Drug: VTX958 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05688852

VTX958-202

Details and patient eligibility

About

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.

Full 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 93 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 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

Enrollment: 107 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 3 patient groups, including a placebo group

VTX958 Dose A

Experimental group

Treatment:

Drug: VTX958

Drug: VTX958

VTX958 Dose B

Experimental group

Treatment:

Drug: VTX958

Drug: VTX958

VTX958 Placebo

Placebo Comparator group

Treatment:

Drug: VTX958 Placebo