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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during screening to week 12
Awards & highlights

Harmony-CD Trial Summary

This trial tests a new medicine to treat Crohn's Disease, with participants monitored for safety and effectiveness.

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.Check my eligibility
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.See study design
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.

Harmony-CD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.

Harmony-CD Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Harmony-CD 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

Find a Location

Who is running the clinical trial?

Ventyx Biosciences, IncLead Sponsor
2 Previous Clinical Trials
427 Total Patients Enrolled

Media Library

VTX958 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05688852 — Phase 2
Crohn's Disease Research Study Groups: VTX958 Dose A, VTX958 Dose B, VTX958 Placebo
Crohn's Disease Clinical Trial 2023: VTX958 Highlights & Side Effects. Trial Name: NCT05688852 — Phase 2
VTX958 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05688852 — Phase 2
~55 spots leftby Jun 2025
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