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Mirikizumab

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What are the phase 2 and 3 clinical studies for mirikizumab 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.

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Clinical Studies

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 and Crohn's disease.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 moderate to severe 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	Active, not recruiting
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	Active, not recruiting
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	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	Active, not recruiting
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
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

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

Study Design Overview

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 ulcerative colitis, and
active Crohn's disease.

Additional information regarding the endpoints are 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	30 pediatric patientsb
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 AP NRS at week 12

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.

bEstimated 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).

Additional information regarding the endpoints are 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
Disease state	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
Enrollment	1281 adult patientsa	1177 adult patientsa	960 adult patientsb
Treatments	MIRI, PBO	MIRI, PBO	MIRI
Ages eligible	18-80 years	18-80 years	18-80 years
Primary outcome	Clinical remission at week 12	Clinical remission at week 40	Clinical remission at week 52
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 UNRS 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 40 Histologic remission at week 40 Symptomatic remission at week 40 Endoscopic response at week 40 Clinical response at week 40 Change from baseline in HRQoL at week 40 Change from baseline in fecal calprotectin at week 40 Change from baseline in UC symptoms using the NRS at week 40 Hospitalizations through week 40 Clearance on weeks 0, 4, 12, 24, and 40	Endoscopic remission at week 52 CS-free remission at week 52 HEMR at week 52 HRQoL (IBDQ) at week 52 UC symptoms using the NRS at week 160 Hospitalizations through week 160 UC surgeries including colectomy through week 160

Abbreviations: CS = corticosteroid; HEMR = Histologic-Endoscopic Mucosal Remission; HRQoL = Health-Related Quality of Life; IBDQ = Inflammatory Bowel Disease Questionnaire score; MIRI = mirikizumab; NRS = numeric rating score; PBO = placebo; UC = ulcerative colitis; UNRS = Urgency Numeric Rating Score.

aActual enrollment.

bEstimated enrollment.

Phase 3 Mirikizumab Clinical Studies in Patients With Moderately-to-Severely Active Crohn's Disease
	NCT03926130 VIVID-1, AMAM	NCT04232553 VIVID-2, AMAX
Disease state	Moderately to severely active CD	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])
Enrollment	1100 adolescent and adult patientsa	778 adult patientsa
Treatments	MIRI, UST, PBO	MIRI
Ages eligible	15-80 years	18 years and older
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 52 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 UNRS at week 12 Change from baseline in UNRS 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 52 Clinical response at week 52 Change from baseline in CRP at week 12 Change from baseline in fecal calprotectin at week 12 Change from baseline in IBDQ at week 52

Abbreviations: AUC = area under curve; CD = Crohn's disease; 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; PRO = patient-reported outcomes; UNRS = Urgency Numeric Rating Score; UST = ustekinumab.

aEstimated enrollment.

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.

Additional information regarding the endpoints are 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	Moderate to severe 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 52 CD: PCDAI clinical remission at week 52
Secondary outcomes	UC: MMS clinical response at week 52 PUCAI clinical response at week 52 PUCAI clinical remission at week 52 Endoscopic remission at week 52 Endoscopic response at week 52 ES = 0 at week 52 HEMR at week 52 CS-free remission without surgery at week 52 CD: PCDAI clinical response at week 52 Endoscopic remission at week 52 Endoscopic response at week 52 based on the SES-CD Histologic response at week 52 CS-free remission without surgery at week 52

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.

Reference

1US National Library of Medicine. ClinicalTrials.gov. February 29, 2000. Accessed December 8, 2022. https://clinicaltrials.gov/

Date of Last Review: December 08, 2022

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