Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
Sponsor type
Laboratory/Research/Testing facility
Therapeutic area
Digestive System Diseases
Decision date
05/02/2026
Enrollment target
110
Sites
France
Condition studied
Crohn's Disease
Investigational medicinal product(s)
Omvoh 100 mg solution for injection in pre-filled penOmvoh 300 mg concentrate for solution for infusionOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 300 mg concentrate for solution for infusionOmvoh 100 mg solution for injection in pre-filled penOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 100 mg solution for injection in pre-filled penOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 100 mg solution for injection in pre-filled penOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 300 mg concentrate for solution for infusionOmvoh 300 mg concentrate for solution for infusionOmvoh 100 mg solution for injection in pre-filled penOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 300 mg concentrate for solution for infusionOmvoh 100 mg solution for injection in pre-filled penOmvoh 300 mg concentrate for solution for infusionOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 100 mg solution for injection in pre-filled penOmvoh 100 mg solution for injection in pre-filled penOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 100 mg solution for injection in pre-filled penOmvoh 100 mg solution for injection in pre-filled penOmvoh 300 mg concentrate for solution for infusionOmvoh 100 mg solution for injection in pre-filled penOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 100 mg + 200 mg solution for injection in pre-filled penOmvoh 200 mg solution for injection in pre-filled syringeOmvoh 300 mg concentrate for solution for infusionOmvoh 100 mg solution for injection in pre-filled pen
Eligibility
Age group
65+ years, 18-64 years
Sex
Female, Male
Primary endpoint
Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24
Endpoint detail
Composite endpoint combining clinical remission and transmural response (TR25) at 6 months, Clinical remission will be defined according to PRO-2, Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline, Improvement or normalization of bowel urgency according to UNRS and Urgent score BU clinical meaningful improvement was defined as decrease of >=3 points, BU Remission was defined as UNRS =<2, Transmural response (TR50): decrease of at least 50% of C-score in each active segment at baseline, Transmural healing: C-score < 0.5 in each active segment at baseline/TRENCH definition, Complete transmural healing: C-score = 0 in each active segment at baseline, MaRIA at 6 months, IUS transmural response/healing at week 4,8, 12 and 24, Bowel damage (Lemann Index) at 6 and 18 months, Clinical response and remission at week 4,8, 12 and 24, Biochemical remission at week 4,8, 12 and 24, Drug retention, IBD-disability index, IBDQ, 10 points-Acceptability numerical scale (ANS), Adverse events and severe adverse events
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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