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VTX958 for Crohn's Disease (Harmony-CD Trial)
Harmony-CD Trial Summary
This trial tests a new medicine to treat Crohn's Disease, with participants monitored for safety and effectiveness.
Harmony-CD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHarmony-CD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Harmony-CD Trial Design
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Who is running the clinical trial?
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- I have a stoma or an ileoanal pouch.I have severe complications from Crohn's disease that might need surgery.I am between 18 and 75 years old.I am able to understand and sign the consent form.I have been diagnosed with a form of colitis.I was diagnosed with Crohn's disease over 3 months ago, confirmed by tests and biopsy.I have been diagnosed with short bowel syndrome.I have never taken VTX958 or any TYK2 inhibitor drugs.
- Group 1: VTX958 Dose A
- Group 2: VTX958 Dose B
- Group 3: VTX958 Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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demonstrates that this research initiative is currently looking for participants to join the trial, which was originally made public on December 22nd 2022 and updated most recently on January 17th 2023."
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."
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."
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."
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"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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