Efficacy of MIrikizumab to achieve traNsmural healing in patiENTs with Crohn’s Disease : EMINENT CD

Start 4 May 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 12 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 110

Countries 1

Sites 12

Crohn's Disease

To describe the efficacy of mirikizumab therapy to achieve transmural response in patients with CD.

Key facts

Sponsor: Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trial duration: 4 May 2026 → ongoing
Decision date (initial): 2026-02-05
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No
Funding sources: Lilly France SAS, an Affiliate of Eli Lilly and Company Corporation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To describe the efficacy of mirikizumab therapy to achieve transmural response in patients with CD.

Secondary objectives 14

To describe the efficacy of mirikizumab therapy to achieve the combination of clinical remission and transmural response in patients with CD.
To describe the efficacy of mirikizumab therapy to achieve transmural healing in patients with CD.
To assess the efficacy of mirikizumab on bowel urgency.
To assess the kinetics of transmural response or healing in patients with CD treated with mirikizumab.
To search for predictors of transmural healing/response in patients treated with mirikizumab.
To assess clinical and biochemical efficacy of mirikizumab therapy.
To assess the clinical and biochemical efficacy time of mirikizumab therapy.
To assess drug retention over time.
To evaluate the impact of mirikizumab therapy to prevent bowel damage progression.
To evaluate the impact of mirikizumab therapy on disability.
To evaluate the impact of mirikizumab therapy on quality of life.
To evaluate the acceptability of mirikizumab therapy.
To assess the safety of mirikizumab.
To assess the correlation between PRO-2, bowel urgency, faecal calprotectin level, CRP, and transmural activity.

Conditions and MedDRA coding

Crohn's Disease

Version	Level	Code	Term	System organ class
28.0	PT	10011401	Crohn´s disease	100000004856

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Experimental arm - mirikizumab 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 responder: SQ injections (300 mg) at week 12 and every 4 weeks - For clinical non-responders: SQ injections (300 mg) at week 12 and every 4 weeks	Not Applicable	None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Patients with CD
≥ 18 years-old ≤ 75 years old
Symptomatic CD according to PRO-2 (stool > 3 or abdominal pain score > 1)
Transmural inflammation on baseline MRI (C-score > 0.5 in at least one segment)

Exclusion criteria 15

Prior exposure to anti-p19 biological therapy
Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase [JAK] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents
Contra-indication to mirikizumab
Definitive ostomy
Colectomy with IPAA
Isolated or uncontrolled perianal lesions
Severe obstructive symptoms
Intra-abdominal abscess
Contra-indication to MRI
No health insurance
Pregnant or lactating women
Patients already included in biomedical research other than an observational study (e.g., registry, cohort)
Concomitant Clostridioides difficile infection
HIV infection
Patient under guardianship, curatorship or safeguard of justice

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24

Secondary endpoints 18

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 36

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12833191 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/015
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12833071 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/015
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12832962 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/015
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12832699 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/015
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD12047280 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/011
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD11951961 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/011
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD12046989 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/011
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD12047150 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/011
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456009 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/006
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10448238 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/006
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456069 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/006
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456059 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/006
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD10456064 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD10456054 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD10448233 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 300 mg concentrate for solution for infusion

PRD10456004 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 900 mg milligram(s)
Max total dose: 2700 mg milligram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100416 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/009
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100412 · Product

Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/009
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100414 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/009
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100410 · Product

Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/009
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10448236 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/004
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456057 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 30 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/004
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456067 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/004
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456007 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/004
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12833070 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/014
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12832698 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/014
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12832961 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/014
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 200 mg solution for injection in pre-filled syringe

PRD12833190 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/014
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456068 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/005
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456008 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/005
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10448237 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/005
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg solution for injection in pre-filled pen

PRD10456058 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/005
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100413 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/010
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100417 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/010
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100415 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/010
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Omvoh 100 mg + 200 mg solution for injection in pre-filled pen

PRD12100411 · Product

Active substance: Mirikizumab
Substance synonyms: LY-3074828
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 300 mg milligram(s)
Max total dose: 4500 mg milligram(s)
Max treatment duration: 15 Month(s)
Authorisation status: Authorised
ATC code: L04AC — -
Marketing authorisation: EU/1/23/1736/010
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Sponsor organisation: Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
Address: 50 Rue Richer
City: Paris
Postcode: 75009
Country: France

Scientific contact point

Organisation: Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
Contact name: Anthony BUISSON

Public contact point

Organisation: Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
Contact name: Anthony BUISSON

Locations

1 EU/EEA country · 12 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	110	12
Rest of world	—	0	—

Investigational sites

France

12 sites · Ongoing, recruiting

Institut Mutualiste Montsouris

gastroenterology, 42 Boulevard Jourdan, 75014, Paris

CH Valence

gastroenterology, 179 Boulevard Maréchal Juin, 26000, Valence

CHU Brest – Hôpital de la Cavale Blanche

gastroenterology, Boulevard Tanguy Prigent, 29200, Brest

CHU Toulouse - Hôpital Rangueil

gastroenterology, 1 Avenue du Professeur Jean Poulhès, 31059, Toulouse cedex 9

CHU Clermont-Ferrand - Hôpital d'Estaing

gastroenterology, 58 rue de Montalembert, 63003, Clermont-Ferrand cedex

CHU Nîmes Carémeau

gastroenterology, 4 rue du Professeur Robert Debré, 30029, Nîmes

CHU de Nice - Hôpital de l'Archet 2

gastroenterology, 151 route Saint-Antoine de Ginestière, 06200, Nice

CHU Amiens Picardie

gastroenterology, Rond point du Pr Cabrol, 80054, Amiens

CHRU de Besançon

gastroenterology, 3 boulevard Fleming, 25030, Besançon Cedex

Hopital Saint Louis

gastroenterology, 1 Avenue Claude Vellefaux, 75010, Paris

APHP - Hôpitaux universitaire Henri Mondor

gastroenterology, 1 ru Gustave Eiffel, 94000, Créteil

Centre Hospitalier Universitaire De Lille

gastroenterology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
France	2026-05-04		2026-05-11

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2025-521889-95-00	2
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K2_Recruitment material patient leaflet FR	2
Subject information and informed consent form (for publication)	L1_SIS and ICF adults FR - Clean	1
Subject information and informed consent form (for publication)	L2_Recruitment material patient diary FR	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC mirikizumab	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis EN 2025-521889-95-00	2
Synopsis of the protocol (for publication)	D1_Protocol synospis FR 2025-521889-95-00	2

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-11-10	France	Acceptable 2026-01-30	2026-02-05
2	SUBSTANTIAL MODIFICATION	SM-1	2026-03-16	France	Acceptable 2026-04-24	2026-05-18

Efficacy of MIrikizumab to achieve traNsmural healing in patiENTs with Crohn’s Disease : EMINENT CD

Overview

Key facts

Trial design

Main objective

Secondary objectives 14

Conditions and MedDRA coding

Study design 1 period

Eligibility criteria

Inclusion criteria 4

Exclusion criteria 15

Endpoints

Primary endpoints 1

Secondary endpoints 18

Investigational products

Test 36

Sponsors and contacts

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 16 files

Application history

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