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Not a traditional drug phase: Epigenome-Guided Treatment Arm for Crohn Disease (CD)

This is a multicentre, prospective, randomly assigned, controlled, open-label study to assess the how well it works, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).

Official registry: https://clinicaltrials.gov/study/NCT07363044 · Alimentiv Inc. · enrollment listed as 378

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Epigenome-Guided Treatment Arm, or Investigator-Guided Treatment Arm. The registry lists allocation as randomized. This is a multicentre, prospective, randomly assigned, controlled, open-label study to assess the how well it works, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).

They plan to enroll about 378 people at 51 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease

Interventions: Epigenome-Guided Treatment Arm, Investigator-Guided Treatment Arm

Primary outcome (registry wording): To compare the efficacy of epigenome-guided treatment selection to usual SOC treatment selection for inducing clinical remission and endoscopic response at Week 26 in participants with active CD.

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Participants must meet all of the following criteria for enrolment into the study:
  • Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy)
  • Active CD, as defined by HBI \> 4 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only
  • Eligible to receive either VDZ and/or UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician
  • If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3 months prior to screening and must be on a stable dose for at least 2 weeks prior to screening
  • If receiving oral corticosteroids, the participant is eligible if they meet all the following criteria:
  • The dose is up to a maximum of prednisone ≤ 40 mg/day or budesonide ≤ 9 mg/day or equivalent

Public study contact (from the registry)

Jennifer Earle

jennifer.earle@alimentiv.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

51 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07363044 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07363044?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07363044?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary