What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include NSAIDs, corticosteroids, immunosuppressants, and biologics. NSAIDs can cause gastrointestinal side effects, including worsening of bowel inflammation. Corticosteroids may lead to weight gain, osteoporosis, hypertension, and increased risk of infections. Immunosuppressants, such as azathioprine and methotrexate, can cause liver toxicity, bone marrow suppression, and increased susceptibility to infections. Biologics, like anti-TNF agents (e.g., infliximab), may result in infusion reactions, increased risk of infections, and potential development of antibodies against the medication.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Crohn's Disease, focusing on anti-inflammatory and immunomodulatory effects. Notable approvals include TNF-alpha inhibitors like infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia), which target and neutralize tumor necrosis factor-alpha, a key inflammatory cytokine. Additionally, integrin inhibitors such as vedolizumab (Entyvio) have been approved, which specifically target gut-selective integrins to reduce inflammation. Ustekinumab (Stelara), an interleukin-12 and interleukin-23 antagonist, is another approved biologic that modulates the immune response. These treatments aim to reduce inflammation and manage symptoms in patients with moderate to severe Crohn's Disease.

What other types of research exist?

Promising novel alternatives to VTX958 for Crohn's Disease patients include: 1) Anti-IL-23 agents such as risankizumab and guselkumab, which target the IL-23 pathway involved in inflammation. 2) JAK inhibitors like upadacitinib and filgotinib, which modulate immune response by inhibiting Janus kinase pathways. 3) S1P receptor modulators such as ozanimod, which reduce lymphocyte migration to inflamed tissues. These therapies are in various stages of clinical development and have shown potential in managing Crohn's Disease.

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VTX958 for Crohn's Disease (Harmony-CD Trial)

Phase 2

Waitlist Available

Research Sponsored by Ventyx Biosciences, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women, 18 to 75 years of age, inclusive, at the time of consent

Be older than 18 years old

Must not have

Presence of a stoma or ileoanal pouch

Presence of currently known complications of CD such as fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during screening to week 12

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical ones may include reactions at the injection site, gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue, and potential immune system impacts since it targets inflammation pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a stoma or an ileoanal pouch.

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

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I have been diagnosed with a form of colitis.

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I have been diagnosed with short bowel syndrome.

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I have never taken VTX958 or any TYK2 inhibitor drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during screening to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during screening to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and during screening to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12

The proportion of participants achieving endoscopic response at Week 12

Secondary study objectives

Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12

Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12

Proportion of participants achieving clinical remission at Week 12

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: VTX958 Dose BExperimental Treatment1 Intervention

Group II: VTX958 Dose AExperimental Treatment1 Intervention

Group III: VTX958 PlaceboPlacebo Group1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include anti-TNF agents (e.g., infliximab, adalimumab), which block tumor necrosis factor, a cytokine involved in systemic inflammation. Immunomodulators (e.g., azathioprine, methotrexate) suppress the immune system to reduce inflammatory responses. Newer biologics (e.g., ustekinumab, vedolizumab) target specific pathways in the immune system, such as interleukins or integrins, to prevent inflammation. These mechanisms are vital for managing Crohn's Disease as they help control the chronic inflammation that leads to symptoms and complications, improving patients' quality of life.

Treat to target: a proposed new paradigm for the management of Crohn's disease.Investigational agents for Crohn's disease.Review article: biological agents in the treatment of Crohn's disease.