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Omvoh ^® (mirikizumab-mrkz) injection

300 mg/15 mL, 100 mg/mL

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What are the phase 2 and 3 clinical studies for Omvoh™ (mirikizumab-mrkz) in inflammatory bowel disease?

Details on phase 2 and phase 3 clinical trials evaluating the use of mirikizumab in patients with inflammatory bowel disease are provided below.

US_cFAQ_MIR106_CLINICAL_STUDIES_IBD

en-US

Content Overview

Overview of Mirikizumab Clinical Trials in Ulcerative Colitis and Crohn's Disease
Detailed Study Design and Methodology for Mirikizumab Clinical Trials
Phase 2 Study of Mirikizumab and Eltrekibart Monotherapy or Combination Therapy in Patients With Ulcerative Colitis

Overview of Mirikizumab Clinical Trials in Ulcerative Colitis and Crohn's Disease

Phase 2 and Phase 3 Mirikizumab Clinical Studies in Patients With Ulcerative Colitis or Crohn's Disease shows the phase 2 and phase 3 mirikizumab clinical studies in patients with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).1

Phase 2 and Phase 3 Mirikizumab Clinical Studies in Patients With Ulcerative Colitis or Crohn's Disease
CT.gov Trial Identifier	Study Title	Disease State	Status
Phase 2 Studies
NCT02891226 SERENITY, AMAG	A study of mirikizumab (LY3074828) in participants with active Crohn's disease (SERENITY)	Active CD	Completed
NCT02589665 AMAC	A study of mirikizumab (LY3074828) in participants with moderately to severely active ulcerative colitis	Moderately to severely active UC	Completed
NCT04004611 SHINE 1, AMBU	A study of mirikizumab (LY3074828) in children and teenagers with ulcerative colitis (SHINE 1)	Moderately to severely active UC	Completed
Phase 3 Studies
NCT03926130 VIVID-1, AMAM	A study of mirikizumab (LY3074828) in participants with Crohn's disease (VIVID-1)	Moderately to severely active CD	Completed
NCT04232553 VIVID-2, AMAX	A long-term extension study of mirikizumab (LY3074828) in participants with Crohn's disease (VIVID-2)	Moderately to severely active CD	Recruiting
NCT03518086 LUCENT 1, AMAN	An induction study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT 1)	Moderately to severely active UC	Active, not recruiting
NCT03524092 LUCENT 2, AMBG	A maintenance study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT 2)	Moderately to severely active UC	Completed
NCT03519945 LUCENT 3, AMAP	A study to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT 3)	Moderately to severely active UC	Recruiting
NCT05767021 LUCENT-URGE, AMBZ	A study of mirikizumab (LY3074828) in participants with moderately to severely active ulcerative colitis (LUCENT-URGE)	Moderately to severely active UC	Active, not recruiting
NCT05784246 SHINE 2, AMBA	A study of mirikizumab (LY3074828) in pediatric participants with moderately to severely or active ulcerative colitis (SHINE 2)	Moderately to severely active UC	Recruiting
NCT04844606 SHINE-ON, AMAZ	A master protocol (AMAZ): a study of mirikizumab (LY3074828) in pediatric participants with ulcerative colitis or Crohn's disease (SHINE-ON)	Moderately to severely active UC or CD	Recruiting
NCT05509777 MACARONI-23, AMAY	A study of mirikizumab (LY3074828) in pediatric participants with Crohn's disease (AMAY)	Moderately to severely active CD	Recruiting

Abbreviations: CD = Crohn’s disease; CT.gov = clinicaltrials.gov; UC = ulcerative colitis.

Detailed Study Design and Methodology for Mirikizumab Clinical Trials

Phase 2 Mirikizumab Clinical Studies in Patients With Ulcerative Colitis or Crohn's Disease provides a brief overview of phase 2 mirikizumab clinical studies, investigating use in patients with

moderately to severely active UC, and
active CD.1

Additional information regarding the endpoints is available on the respective clinicaltrials.gov postings.

Phase 2 Mirikizumab Clinical Studies in Patients With Ulcerative Colitis or Crohn's Disease
	NCT02891226 SERENITY, AMAG	NCT02589665 AMAC	NCT04004611 SHINE 1, AMBU
Disease state	Active CD	Moderately to severely active UC	Moderately to severely active UC
Study design	Randomized, parallel-arm, PBO-controlled	Randomized, double-blind, parallel, PBO-controlled	Nonrandomized, parallel-arm
Enrollment	191 adult patientsa	249 adult patientsa	26 pediatric patientsa
Treatments	MIRI, PBO	MIRI, PBO	MIRI
Ages eligible	18-75 years	18-75 years	2-17 years
Primary outcome	Endoscopic response at week 12	Induction period: Clinical remission at week 12	Clearance through week 52
Secondary outcomes	Endoscopic remission at week 12 PRO remission at week 12 Change from baseline on PGRS CD score at week 12 Mean PGRC CD score at week 12 Change from baseline on IBDQ at week 12 Change from baseline on FACIT-F at week 12 Change from baseline on SF-36 PCS and MCS at week 12 Clearance and volume of distribution at predose weeks 0, 4, and 8, and at defined time frames from end of infusion week 2 through 208 weeks postinfusion	Induction period: Clinical response at week 12 Endoscopic remission at week 12 Change from baseline in IBDQ at week 12 Change from baseline in SF-36 at week 12 Change from baseline in PGI-S at week 12 PGI-I at week 12 Symptomatic remission at week 12 Endoscopic improvement at week 12 Maintenance period: Endoscopic remission at week 52 Symptomatic remission at week 52 Endoscopic improvement at week 52 AUC at defined time frames from induction period day 1 through day 840	Clinical remission at week 52 Clinical response at week 52 MMS clinical remission without CS at week 52 Clinical remission by PUCAI at week 52 Clinical response by PUCAI at week 52 Endoscopic remission at week 52 Symptomatic remission at week 52 Height velocity at week 52 Change from baseline in body weight at week 52 HEMR at week 52 Change from baseline in 7-day average of Abdominal Pain NRS score at week 12 Change from baseline in 7-day average of Abdominal Pain NRS score at week 52

Abbreviations: AUC = area under curve; CD = Crohn’s disease; CS = corticosteroid; FACIT-F = Functional Assessment of Chronic Illness Therapy-Fatigue; HEMR = histologic-endoscopic mucosal remission; IBDQ = Inflammatory Bowel Disease Questionnaire score; MCS = Mental Component Summary; MIRI = mirikizumab; MMS = Modified Mayo score; NRS = Numeric Rating Scale; PBO = placebo; PCS = Physical Component Summary; PGI-I = Patient Global Impression of Improvement; PGI-S = Patient Global Impression of Severity; PGRC = Patient Global Rating of Change; PGRS = Patient Global Rating of Severity; PRO = patient reported outcome; PUCAI = Pediatric Ulcerative Colitis Activity Index; SF-36 = Medical Outcomes Study 36-Item Short Form Health Survey; UC = ulcerative colitis.

aActual enrollment.

Phase 3 Mirikizumab Clinical Studies in Patients With Moderately to Severely Active Ulcerative Colitis and Phase 3 Mirikizumab Clinical Studies in Patients With Moderately to Severely Active Crohn's Disease provide a brief overview of phase 3 mirikizumab clinical studies in patients with

moderately to severely active UC (Phase 3 Mirikizumab Clinical Studies in Patients With Moderately to Severely Active Ulcerative Colitis), and
moderately to severely active CD (Phase 3 Mirikizumab Clinical Studies in Patients With Moderately to Severely Active Crohn's Disease).1

Additional information regarding the endpoints is available on the respective clinicaltrials.gov postings.

Phase 3 Mirikizumab Clinical Studies in Patients With Moderately to Severely Active Ulcerative Colitis
	NCT03518086 LUCENT 1, AMAN	NCT03524092 LUCENT 2, AMBG	NCT03519945 LUCENT 3, AMAP	NCT05767021 LUCENT-URGE, AMBZ	NCT05784246 SHINE 2, AMBA
Disease state	Moderately to severely active UC	Moderately to severely active UC	Moderately to severely active UC	Moderately to severely active UC	Moderately to severely active UC
Study design	Randomized, double-blind, parallel, PBO-controlled induction	Randomized, double-blind, parallel-arm, PBO-controlled maintenance	Open-label extension	Phase 3b, single-arm, open-label	Nonrandomized, parallel-arm, open-label
Enrollment	1281 adult patientsa	1177 adult patientsa	1063 adult patientsb	160 adult patientsb	60 pediatric patientsb
Treatments	MIRI, PBO	MIRI, PBO	MIRI	MIRI	MIRI
Ages eligible	18-80 years	18-80 years	18-80 years	≥18 years	2-17 years
Primary outcome	Clinical remission at week 12	Clinical remission at week 40c	Clinical remission at week 52d	Change from baseline in Urgency NRS score at week 12	MMS clinical remission at week 52 among week 12 clinical responders
Secondary outcomes	Clinical response at week 12 Endoscopic remission at week 12 Symptomatic remission at week 12 Symptomatic response at week 12 Histologic remission at week 12 Endoscopic response at week 12 Change from baseline in Urgency NRS score at week 12 Change from baseline in HRQoL (IBDQ) at week 12 Change from baseline in fecal calprotectin at week 12 Clearance on predose weeks 0, 4, and 8 and postdose on weeks 0, 4, and 12	Endoscopic remission at week 40c Histologic remission at week 40c Symptomatic remission at week 40c Endoscopic response at week 40c Clinical response at week 40c Change from baseline in HRQoL at week 40c Change from baseline in fecal calprotectin at week 40c Change from baseline in bowel urgency based on the Urgency NRS score at week 40c Hospitalizations through week 40c Clearance on weeks 0, 4, 12, 24, and 40c	Endoscopic remission at week 52d CS-free remission at week 52d HEMR at week 52d HRQoL (IBDQ) at week 52d UC symptoms using the NRS score at week 160 Hospitalizations through week 160 UC surgeries including colectomy through week 160	Change from baseline in bowel urgency frequency at week 12 Clinically meaningful improvement in bowel urgency frequency from baseline to week 12 Change from baseline in stool deferral time at week 12 Clinically meaningful improvement in stool deferral time at week 12 Clinical remission at week 12 based on MMS and an Urgency NRS score ≤1 Clinical response at week 12 based on MMS and an Urgency NRS score ≥3 points of improvement from baseline Pairwise correlations between Urgency NRS score, bowel urgency frequency, stool deferral time, and absorbent product use measures from baseline to week 12 Pairwise correlations between change in Urgency NRS score, bowel urgency frequency, stool deferral time, and absorbent product use measures from baseline to week 12 Correlation between the Urgency NRS score, bowel urgency frequency, stool deferral time, and absorbent product use measures with QoL/functional outcome measures and UC symptom measures from baseline to week 12 Correlation between change in Urgency NRS score, bowel urgency frequency, stool deferral time, and absorbent product use measures with change in QoL/functional outcome measures and UC symptom measures from baseline to week 12	MMS clinical remission at week 12 MMS clinical response at week 12 Endoscopic remission at week 12 Endoscopic improvement at week 12 Clinical response by PUCAI at week 12 Clinical remission PUCAI at week 12 HEMR at week 12 MMS clinical response at week 52 MMS clinical remission at week 52 Clinical response PUCAI at week 52 Clinical remission PUCAI at week 52 Endoscopic remission at week 52 Endoscopic improvement at week 52 MMS clinical remission without surgery at week 52 among clinical responders at week 12 and without CS HEMR at week 52 AUC from baseline to week 52 C_maxfrom baseline to week 52

Abbreviations: AUC = area under the curve; C_max = maximum concentration; CS = corticosteroid; HEMR = histologic-endoscopic mucosal remission; HRQoL = Health-Related Quality of Life; IBDQ = Inflammatory Bowel Disease Questionnaire score; MIRI = mirikizumab; MMS = Modified Mayo score; NRS = Numeric Rating Scale; PBO = placebo; PUCAI = Pediatric Ulcerative Colitis Activity Index; QoL = Quality of Life; UC = ulcerative colitis.

aActual enrollment.

bEstimated enrollment.

cRepresenting 52 weeks of continuous treatment.

dRepresenting 104 weeks of continuous treatment.

Phase 3 Mirikizumab Clinical Studies in Patients With Moderately to Severely Active Crohn's Disease
	NCT03926130 VIVID-1, AMAM	NCT04232553 VIVID-2, AMAX	NCT05509777 MACARONI-23, AMAY
Disease state	Moderately to severely active CD	CD	Moderately to severely active CD
Study design	Randomized, double-blind, PBO- and active-controlled treat-through with open-label adolescent addendum	Open-label, long-term extension (patients must have completed SERENITY [AMAG] or VIVID-1 [AMAM])	Randomized- parallel-arm; open-label
Enrollment	1158 adolescent and adult patientsa	778 adult patientsb	90 pediatric patientsb
Treatments	MIRI, UST, PBO	MIRI	MIRI
Ages eligible	18-80 years2	18 years and older	2-17 years
Primary outcome	Clinical response at week 12 and endoscopic response at week 52 Clinical response at week 12 and clinical remission at week 52	Endoscopic response at week 52c Clinical remission at week 52c	PCDAI clinical response at week 12 and endoscopic response based on the SES-CD at week 52 PCDAI clinical response at week 12 and PCDAI clinical remission at week 52
Secondary outcomes	Endoscopic response at week 52 Clinical remission at week 52 Endoscopic response at week 12 Endoscopic remission at week 12 Clinical remission at week 12 Change from baseline in Urgency NRS score at week 12 Change from baseline in Urgency NRS score at week 52 Clinical response at week 12 and clinical remission by PRO at week 52 Clinical response at week 12 and endoscopic remission at week 52 Clinical response at week 12 and CS-free and either clinical remission or endoscopic remission at week 52 Change from baseline in CRP at week 52 Change from baseline in fecal calprotectin at week 52 EIMs of CD at week 52 Fistulae response at week 52 AUC from baseline through week 52 Change from baseline in HRQoL at week 52	Endoscopic remission at week 52c Clinical response at week 52c Change from baseline in CRP at week 12d Change from baseline in fecal calprotectin at week 12d Change from baseline in IBDQ at week 52c	PCDAI clinical response at week 12 CDAI clinical response week 12e PCDAI clinical remission at week 12 CDAI clinical remission at week 12e Endoscopic response based on the SES-CD at week 12 PCDAI clinical response at week 12 and Endoscopic remission based on the SES-CD at week 52 Change from baseline in CRP at week 12 Change from baseline in CRP at week 52 Change from baseline in fecal calprotectin at week 12 Change from baseline in fecal calprotectin at week 52 PCDAI clinical response at week 12 and CDAI clinical remission at week 52f Endoscopic response based on the SES-CD at week 52 PCDAI clinical remission at week 52 PCDAI clinical response at week 12 and PCDAI clinical remission without the use of CS and who did not have Crohn's disease-related surgery at week 52 Clearance of mirikizumab Volume of distribution of mirikizumab

Abbreviations: AUC = area under curve; CD = Crohn's disease; CDAI = Clinical Disease Activity Index; CRP = C-reactive protein; CS = corticosteroid; EIM = extraintestinal manifestation; HRQoL = Health-Related Quality of Life; IBDQ = Inflammatory Bowel Disease Questionnaire score; MIRI = mirikizumab; NRS = Numeric Rating Scale; PBO = placebo; PCDAI = Pediatric Crohn's Disease Activity Index; PRO = patient-reported outcomes; SES-CD = Simple Endoscopic Score for Crohn's Disease; UST = ustekinumab.

aActual enrollment.

bEstimated enrollment.

cRepresenting 104 weeks of continuous treatment.

dRepresenting 64 weeks of continuous treatment.

eCDAI for patients ≥12 years of age.

fClinical response by PCDAI, CDAI for participants ≥12 years of age.

Phase 3 Mirikizumab Clinical Study in Pediatric Patients With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis provides a brief overview of a phase 3 mirikizumab clinical study in pediatric patients with moderately to severely active UC or CD.1

Additional information regarding the endpoints is available on the clinicaltrials.gov posting.

Phase 3 Mirikizumab Clinical Study in Pediatric Patients With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
	NCT04844606 SHINE-ON, AMAZ
Disease state	Moderately to severely active UC or CD
Study design	Open-label, long-term extension
Enrollment	150 children and adolescent patientsa
Treatments	MIRI
Ages eligible	2-19 years
Primary outcomes	UC: MMS clinical remission at week 52b CD: PCDAI clinical remission at week 52b
Secondary outcomes	UC: MMS clinical response at week 52b PUCAI clinical response at week 52b PUCAI clinical remission at week 52b Endoscopic remission at week 52b Endoscopic response at week 52b ES = 0 at week 52b HEMR at week 52b CS-free remission without surgery at week 52b CD: PCDAI clinical response at week 52b Endoscopic remission at week 52b Endoscopic response at week 52b based on the SES-CD Histologic response at week 52b CS-free remission without surgery at week 52b

Abbreviations: CD = Crohn's Disease; CS = corticosteroid; ES = endoscopic subscore; HEMR = Histologic-Endoscopic Mucosal Remission; MIRI = mirikizumab; MMS = Modified Mayo score; PCDAI = Pediatric Crohn's Disease Activity Index; PUCAI = Pediatric Ulcerative Colitis Activity Index; SES-CD = Simple Endoscopic Score for Crohn's Disease; UC = ulcerative colitis.

aEstimated enrollment.

bRepresenting 104 weeks of continuous treatment.

Phase 2 Study of Mirikizumab and Eltrekibart Monotherapy or Combination Therapy in Patients With Ulcerative Colitis

A phase 2, double-blind, interventional, randomized, parallel assignment, placebo-controlled study is investigating the safety and efficacy of mirikizumab and eltrekibart in adult patients with moderately to severely active ulcerative colitis. To participate in the study, patients must have had an inadequate response, loss of response, or intolerance to at least one conventional medication, including corticosteroids, or one advanced therapy, such as biologics, Janus kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators.3

Phase 2 Clinical Study of Mirikizumab and Eltrekibart in Patients With Ulcerative Colitis shows additional details regarding this study.

Phase 2 Clinical Study of Mirikizumab and Eltrekibart in Patients With Ulcerative Colitis3
Study Feature	Description
Disease state	Moderately to severely active ulcerative colitis
Study design	Double-blind, randomized, parallel-assignment, placebo-controlled
Enrollment	140 adult patientsa
Study duration	Approximately 69 weeks for each participant including screening period
Treatments	Mirikizumab, eltrekibart, combination of both mirikizumab and eltrekibart, or placebo
Ages eligible	18-75 years
Primary outcome	Clinical remission at week 12
Secondary outcomes	Clinical response at week 12 Endoscopic improvement at week 12 Endoscopic remission at week 12 Clinical remission at week 52 HEMI at week 12 Change from baseline in IBDQ total score at week 12 C_{trough ss} of mirikizumab at week 12

Abbreviations: C_{trough ss}= trough concentration at steady state; HEMI = histologic-endoscopic mucosal improvement; IBDQ = Inflammatory Bowel Disease Questionnaire score.

aEstimated enrollment.

Enclosed Prescribing Information

OMVOH™ (mirikizumab-mrkz) injection, for intravenous or subcutaneous use, Lilly

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1US National Library of Medicine. ClinicalTrials.gov. February 29, 2000. Accessed June 7, 2024. https://clinicaltrials.gov/

2Ferrante M, D'Haens G, Jairath V, et al; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. Published online November 21, 2024. https://doi.org/10.1016/S0140-6736(24)01762-8

3A study of eltrekibart and mirikizumab in adult patients with moderately to severely active ulcerative colitis. ClinicalTrials.gov identifier: NCT06598943. Updated September 19, 2024. Accessed September 19, 2024. https://clinicaltrials.gov/show/NCT06598943

Date of Last Review: November 25, 2024

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Omvoh ® (mirikizumab-mrkz) injection

300 mg/15 mL, 100 mg/mL

What are the phase 2 and 3 clinical studies for Omvoh™ (mirikizumab-mrkz) in inflammatory bowel disease?

Details on phase 2 and phase 3 clinical trials evaluating the use of mirikizumab in patients with inflammatory bowel disease are provided below.

Content Overview

Overview of Mirikizumab Clinical Trials in Ulcerative Colitis and Crohn's Disease

Detailed Study Design and Methodology for Mirikizumab Clinical Trials

Phase 2 Study of Mirikizumab and Eltrekibart Monotherapy or Combination Therapy in Patients With Ulcerative Colitis

Enclosed Prescribing Information

References

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Omvoh ^® (mirikizumab-mrkz) injection