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

Phase 2
Recruiting
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants younger than 40 years of age being considered for this research initiative?

"The study is only open to participants aged 18 through 75. For those younger or older, 67 trials are available for under-18's and 197 exist for seniors over 65 years old."

Answered by AI

Are recruitment efforts ongoing for this clinical experiment?

"An examination of clinicaltrials.gov demonstrates that this research initiative is currently looking for participants to join the trial, which was originally made public on December 22nd 2022 and updated most recently on January 17th 2023."

Answered by AI

Does VTX958 Dose A pose a risk to participants receiving the treatment?

"Though the efficacy of VTX958 Dose A has yet to be established, there is some data confirming its safety. Thus, our team at Power has assigned it a score of 2 out of 3 on their scale."

Answered by AI

How many individuals are involved in this research endeavor?

"Affirmative. Clinicaltrials.gov's records denote that this experiment, which was initially posted on December 22nd 2022, is still actively recruiting participants. This research venture requires the enrolment of 132 volunteers at one medical site."

Answered by AI

Am I eligible to participate in this trial?

"This research project is enrolling 132 persons with Crohn's disease in the age range of 18-75 years. Qualified candidates must meet certain standards: gender, consent procurement capacity, medical documentation confirming diagnosis for at least 3 months before Day 1, and exhibit moderately to severely active symptoms."

Answered by AI

What are the overarching aims of this research endeavor?

"This trial's primary objective, which will be evaluated between screening and Week 12, is the proportion of patients achieving endoscopic response by this time. Secondary outcomes for evaluation include: Proportion of participants achieving clinical remission at Week 12 (as defined by a CDAI score < 150), Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12 (defined as an unweighted CDAI component with daily AP score ≤ 1 and average stool frequency score ≤ 3), and Proportion of participants attaining clinical response at Week 12 (defined as ≥ 100 points reduction from baseline in their CDAI"

Answered by AI

Who else is applying?

What site did they apply to?
Local Site # 840111
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I was diagnosed in 2005 with Severe Crohn's Disease. I have been taking Humira Injections for 13 years. I am currently looking for a new treatment to help my internal organs.
PatientReceived no prior treatments
~8 spots leftby Jun 2024