VTX958 for Crohn's Disease

(Harmony-CD Trial)

No longer recruiting at 120 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, VTX958, for individuals with moderately to severely active Crohn's Disease, a condition that inflames the digestive tract. The goal is to evaluate the effectiveness and safety of VTX958 compared to a placebo (a harmless pill with no active ingredient). Participants will receive either one of two doses of VTX958 or the placebo. The trial seeks individuals who have had Crohn's Disease for at least three months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VTX958 is generally well-tolerated by people with Crohn's Disease. Studies found that using VTX958 for 12 weeks did not cause any serious side effects, suggesting it is relatively safe for humans. Although the study did not achieve its main goal of improving symptoms, the safety results remain positive. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's Disease?

Unlike the standard treatments for Crohn's Disease, which often include anti-inflammatory drugs and immune system suppressors like corticosteroids and biologics, VTX958 represents a novel approach by targeting a different pathway. Researchers are excited about VTX958 because it acts on the TYK2 enzyme, which plays a critical role in immune system regulation. This new mechanism of action has the potential to provide relief with possibly fewer side effects and more precise targeting of the disease process. Additionally, with different dosing options being tested, VTX958 may offer flexibility in treatment plans to better suit individual patient needs.

What evidence suggests that VTX958 might be an effective treatment for Crohn's Disease?

Research has shown that VTX958 has been tested for treating Crohn's disease. One study found that it did not achieve its main goal of improving the Crohn's Disease Activity Index (CDAI), which measures disease severity. Despite this, some evidence suggests that VTX958 might still help by potentially altering the disease's progression. The treatment was well-tolerated, causing few serious side effects. While these findings are encouraging, more research is needed to fully understand its potential in treating Crohn's disease. Participants in this trial will receive either VTX958 at different dosages or a placebo to further evaluate its effectiveness and safety. ^{1 2 3 4 5}

Who Is on the Research Team?

Snehal Naik, PhD

Principal Investigator

Ventyx Biosciences, Inc

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05688852

NCT05688852 | VTX958 for the Treatment of Moderately to ... This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with ...

2. ir.ventyxbio.com ir.ventyxbio.com/news-releases/news-release-details/ventyx-biosciences-announces-results-phase-2-trial-vtx958-0

Release Details The Phase 2 trial of VTX958 in Crohn's disease did not meet its primary endpoint of change from baseline in mean CDAI score in either VTX958 dose group.

3. stanfordbiotechgroup.com stanfordbiotechgroup.com/insights/ventyx-rise-and-fall

Analyzing the Rise and Fall of Ventyx's Primary Candidate Remicade, which has shown promising results in Crohn's disease, also exhibits strong performance in UC at both 30 and 54 weeks, achieving a ...

4. ir.ventyxbio.com ir.ventyxbio.com/news-releases/news-release-details/ventyx-biosciences-announces-presentation-data-phase-2-trial

Release Details “These Phase 2 data suggest that VTX958 has the potential for disease-modifying benefit in Crohn's disease, including strong effects on ...

5. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i1853/7968106

P1001 Efficacy and safety of an oral tyrosine kinase 2 inhibitor ... Twelve weeks treatment with VTX958 was well-tolerated in patients with CD. Although the primary endpoint of CDAI change from baseline was not ...