A Phase 4 interventional study of Mirikizumab - IV and Mirikizumab - SC in Crohn Disease (CD), sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Recruiting at 8 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Phase 4, Interventional, and Supportive care
Among 10 studies testing mirikizumab in Crohn Disease — 7 open to participants now, 8 under way, 3 of them phase 3. mirikizumab · Crohn Disease.
Among the 10 studies testing mirikizumab in Crohn Disease, this one is the 8th largest by planned enrollment, is one of 4 that started in 2026, is one of 5 in phase 4, and was the 8th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 75 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →7 of the 10 studies testing mirikizumab in Crohn Disease are open now, in 12 countries. Each count lists the studies.
mirikizumab: first FDA approval 2023 (OMVOH), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 4 started in 2026.
Median enrollment 150 across the 10 interventional studies. Of the 2 that completed or were terminated, 2 (100%) have results posted.
6 of 10 have an industry lead sponsor. The 6 most frequent:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: 5 open now, 6 under way, none of them phase 3. Of 15 finished, 0 (0%) have results posted.
Among the 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, this one is the 12th largest by planned enrollment of the 16 interventional ones, is one of 3 that started in 2026, is one of 9 in phase 4, and was the 20th registered.
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives’s Crohn Disease studies by the year they started, since 2002.
2 of the studies testing mirikizumab in Crohn Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06997965Alimentiv Inc.Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD | 2027-09-01 |
| NCT07292012Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesEfficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease | 2027-11 |
Among the 10 studies testing mirikizumab in Crohn Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives’s 22 in Crohn Disease:
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mirikizumab will be used as scheduled in the drug label: induction with IV infusions (900 mg) at week 0, week 4 and week 8. For clinical responders: SC injections (300 mg) at W12 and every 4 weeks For clinical non-responders: SC injections (300 mg) at W12 and every 4 weeks
Drug: Mirikizumab - IV · Drug: Mirikizumab - SC
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders
Transmural response (TR25)
Transmural response (TR25) define as the decrease of at least (\>=) 25% of C-score in each and all active segment from baseline to week 24
Time frame: From week 0 to week 24
Clinical remission
Clinical remission will be defined according to PRO-2 (Patient Report Outcome)
Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Improvement or normalization of bowel urgency
Improvement or normalization of bowel urgency according to UNRS (Urgency Numerical Rating Scale)
Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
BU clinical meaningful improvement
BU clinical meaningful improvement was defined as decrease of \>=3 points; BU Remission was defined as UNRS =\<2
Time frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Transmural response (TR50)
Transmural response (TR50) is defined as a decrease of at least 50% of C-score in each active segment at baseline
Time frame: Week 0, Week 24, Week 76
Transmural healing
Transmural healing is defined as a C-score \< 0.5 in each active segment at baseline
Time frame: at Week 0, Week 24, Week 76
Disease activity
Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity)
Time frame: Week 0, Week 24, Week 76
IUS transmural response/healing
IUS transmural response/healing
Time frame: Week 4, Week 8, Week 12, Week 24
Bowel damage
Bowel damage is measured with the Lemann Index
Time frame: Week 24, Week 76
Transmural response (TR25)
Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline
Time frame: Week 0, Week 4, Week 24, Week 76
Not enrolling at this site.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Mirikizumab
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives