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Omvoh ™ (mirikizumab-mrkz) injection
300 mg/15 mL, 100 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What are the phase 2 and 3 clinical studies for Omvoh™ (mirikizumab-mrkz) in inflammatory bowel disease?
Phase 2 and 3 clinical studies are investigating the use of mirikizumab in patients with ulcerative colitis and Crohn's disease. Details on these studies are provided.
Clinical Studies
shows the phase 2 and phase 3 mirikizumab clinical studies in patients with moderately to severely active ulcerative colitis and Crohn's disease.1
CT.gov |
Study Title |
Disease State |
Status |
Phase 2 Studies |
|||
SERENITY, AMAG |
A study of mirikizumab (LY3074828) in participants with active Crohn's disease (SERENITY) |
Active CD |
Completed |
AMAC |
A study of mirikizumab (LY3074828) in participants with moderately to severely active ulcerative colitis |
Moderately to severely active UC |
Completed |
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 |
|||
VIVID-1, AMAM |
A study of mirikizumab (LY3074828) in participants with Crohn's disease (VIVID-1) |
Moderately to severely active CD |
Active, not recruiting |
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 |
LUCENT 1, AMAN |
An induction study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT 1) |
Moderately to severely active UC |
Recruiting |
LUCENT 2, AMBG |
A maintenance study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT 2) |
Moderately to severely active UC |
Recruiting |
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 |
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 |
Not yet recruiting |
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 |
MACARONI-23, AMAY |
A study of mirikizumab (LY3074828) in pediatric participants with Crohn's disease (AMAY) |
Moderately to severely active CD |
Not yet recruiting |
Abbreviations: CD = Crohn’s disease; CT.gov = clinicaltrials.gov; UC = ulcerative colitis.
Study Design Overview
provides a brief overview of phase 2 mirikizumab clinical studies, investigating use in patients with
- moderately to severely active ulcerative colitis, and
- active Crohn's disease.
Additional information regarding the endpoints are available on the respective clinicaltrials.gov postings.
|
SERENITY, AMAG |
AMAC |
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: |
Clearance through week 52 |
Secondary outcomes |
Endoscopic remission at week 12 |
Induction period: Maintenance period: AUC at defined time frames from induction period day 1 through day 840 |
Clinical remission at week 52 |
Abbreviations: AP = abdominal pain; 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 score; 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.
and provide a brief overview of phase 3 mirikizumab clinical studies in patients with
Additional information regarding the endpoints are available on the respective clinicaltrials.gov postings.
|
LUCENT 1, AMAN |
LUCENT 2, AMBG |
LUCENT 3, AMAP |
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 |
Study design |
Randomized, double-blind, parallel, PBO-controlled induction |
Randomized, double-blind, parallel-arm, PBO-controlled maintenance |
Open-label extension |
Nonrandomized, parallel-arm, open-label |
Enrollment |
1281 adult patientsa |
1177 adult patientsa |
960 adult patientsb |
60 pediatric patientsb |
Treatments |
MIRI, PBO |
MIRI, PBO |
MIRI |
MIRI |
Ages eligible |
18-80 years |
18-80 years |
18-80 years |
2-17 years |
Primary outcome |
Clinical remission at week 12 |
Clinical remission at week 40c |
Clinical remission at week 52d |
MMS clinical remission at week 52 among week 12 clinical responders |
Secondary outcomes |
Clinical response at week 12 |
Endoscopic remission at week 40c |
Endoscopic remission at week 52d |
MMS clinical remission at week 12 |
Abbreviations: AUC = area under the curve; Cmax = 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 score; PBO = placebo; PUCAI = Pediatric Ulcerative Colitis Activity Index; UC = ulcerative colitis; UNRS = Urgency Numeric Rating Score.
aActual enrollment.
bEstimated enrollment.
cRepresenting 52 weeks of continuous treatment.
dRepresenting 104 weeks of continuous treatment.
|
VIVID-1, AMAM |
VIVID-2, AMAX |
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 |
1100 adolescent and adult patientsa |
778 adult patientsa |
90 pediatric patientsa |
Treatments |
MIRI, UST, PBO |
MIRI |
MIRI |
Ages eligible |
15-80 years |
18 years and older |
2-17 years |
Primary outcome |
Clinical response at week 12 and endoscopic response at week 52 |
Endoscopic response at week 52b |
PCDAI clinical response at week 12 and endoscopic response based on the SES-CD at week 52 |
Secondary outcomes |
Endoscopic response at week 52 |
Endoscopic remission at week 52b |
PCDAI clinical response at week 12 |
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; PBO = placebo; PCDAI = Pediatric Crohn's Disease Activity Index; PRO = patient-reported outcomes; SES-CD = Simple Endoscopic Score for Crohn's Disease; UNRS = Urgency Numeric Rating Score; UST = ustekinumab.
aEstimated enrollment.
bRepresenting 104 weeks of continuous treatment.
cRepresenting 64 weeks of continuous treatment.
dCDAI for patients ≥12 years of age.
eClinical response by PCDAI, CDAI for participants ≥12 years of age.
provides a brief overview of a phase 3 mirikizumab clinical study in pediatric patients with moderately to severely active UC or CD.
Additional information regarding the endpoints are available on the clinicaltrials.gov posting.
|
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: CD: |
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.
Enclosed Prescribing Information
Reference
1US National Library of Medicine. ClinicalTrials.gov. February 29, 2000. Accessed May 25, 2023. https://clinicaltrials.gov/
Date of Last Review: May 25, 2023