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NCT07363044: OMICROHN
A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease
NA trial testing Epigenome-Guided Treatment Arm in Crohn Disease (CD) in 378 participants. Currently enrolling.
1 June 2027
Quick facts
| Lead sponsor | Alimentiv Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 378 |
| Start date | 1 February 2025 |
| Primary completion | 1 June 2027 |
| Estimated completion | 1 January 2029 |
| Sites | 39 locations across Belgium, Italy, Netherlands, Slovenia, United Kingdom |
Drugs / interventions tested
- Epigenome-Guided Treatment Arm
- Investigator-Guided Treatment Arm
Conditions studied
- Crohn Disease (CD) — all drugs for Crohn Disease (CD) →
Sponsor
Alimentiv Inc. — full company profile →
Who can join
18 and older, any sex, with Crohn Disease (CD). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Time frame: Baseline to Week 26
Corticosteroid-free clinical remission (Harvey-Bradshaw Index \[HBI\] score ≤ 4) and endoscopic response (≥ 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease \[SES-CD\])
Sponsor's own description
This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, 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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07363044
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Crohn Disease (CD)
Currently open trials in the same condition.
- NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
- NCT07245394 — Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD) · recruiting
- NCT07224113 — Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07195123 — Evaluation of the SMART IBD App in Pediatric IBD · NA · recruiting
Other Alimentiv Inc. trials
Trials by the same sponsor.
- NCT06997965 — Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD · Phase 4 · not yet recruiting
- NCT06257706 — VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease · Phase 4 · recruiting
- NCT06670638 — Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Pe · recruiting
- NCT05252273 — Assessment of Patients With Acute Pouchitis Treated With Antibiotics · suspended
- NCT04576000 — Identification of Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07363044 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alimentiv Inc.
- Last refreshed: 28 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07363044.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing