VTX958 for Crohn's Disease

(Harmony-CD Trial)

Recruiting at 106 trial locations

Overseen By Ventyx Clinical Trial Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ventyx Biosciences, Inc

Must not be taking: TYK2 inhibitors

Disqualifiers: Ulcerative colitis, Stoma, Short gut, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new medication called VTX958 to help people with moderate to severe Crohn's Disease. The goal is to see if it can reduce inflammation in the intestines and improve symptoms. The study will involve several phases over a period of up to three years.

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-75 with a confirmed diagnosis of Crohn's Disease (CD) that's moderately to severely active. They must have known they had CD for at least 3 months and be able to consent. People can't join if they've tried VTX958 or similar drugs, have other types of colitis, complications from CD requiring surgery, or have a stoma or ileoanal pouch.

Inclusion Criteria

I am able to understand and sign the consent form.

I was diagnosed with Crohn's disease over 3 months ago, confirmed by tests and biopsy.

Moderately to severely active CD

Exclusion Criteria

I have a stoma or an ileoanal pouch.

I have severe complications from Crohn's disease that might need surgery.

I have been diagnosed with a form of colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Induction Treatment

Participants receive double-blind treatment to evaluate the efficacy and safety of VTX958

12 weeks

Maintenance Treatment

Participants continue double-blind treatment to maintain response

40 weeks

Open-Label Extension

Participants may opt into continuation of treatment long-term

144 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VTX958
• VTX958 Placebo

Trial Overview The study tests the effectiveness and safety of VTX958 compared to a placebo in treating Crohn's Disease. Participants are randomly assigned to receive either VTX958 or an inactive substance without knowing which one they're getting, ensuring the results are unbiased.

How Is the Trial Designed?

Group I: VTX958 Dose B Experimental Treatment 1 Intervention

Group II: VTX958 Dose A Experimental Treatment 1 Intervention

Group III: VTX958 Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Ventyx Biosciences, Inc

Lead Sponsor

Trials

3

Recruited

560+