29 completed, 11 recruiting, 4 active not recruiting, 3 not yet recruiting. 18 Phase 1, 15 Phase 3, 8 Phase 2, 8 Phase 4.
Follow mirikizumab: new trials by email Literature Review of mirikizumab trials Research Report on mirikizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease Mirikizumab, Fistula Tract Curettage and Closure - Crohn's Disease, Perianal Fistula | Phase 4 | Not yet recruiting | Icahn School of Medicine at Mount Sinai | 50 | 2026-12-01 | 2026-08-24 |
| INSIGHT-IBD Pragmatic Study Mirikizumab, Anti-TNF agents, anti-integrin antibodies - Ulcerative Colitis (UC), Crohn Disease (CD) | Phase 4 | Enrolling by invitation | Specialty Networks Research. | 400 | 2026-08-12 | 2026-10-02 |
| A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication Mirikizumab - Lactation, Inflammatory Bowel Disease | Phase 4 | Recruiting | Eli Lilly and Company | 14 | 2026-08-05 | 2026-09-08 |
| Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease Mirikizumab, Azathioprine (AZA) - Chrohn's Disease | Phase 4 | Not yet recruiting | University Hospital Schleswig-Holstein | 320 | 2026-08-01 | 2026-06-22 |
| A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease LY4395089, Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC) - Crohn Disease | Phase 2 | Recruiting | Eli Lilly and Company | 60 | 2026-05-04 | 2026-10-08 |
| A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC), LY4395089 - Colitis, Ulcerative, Crohn Disease | Phase 2 | Recruiting | Eli Lilly and Company | 60 | 2026-05-04 | 2026-10-22 |
| Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD Mirikizumab - Crohn Disease | Phase 4 | Recruiting | Alimentiv Inc. | 60 | 2026-04-20 | 2026-07-16 |
| A Study of Mirikizumab Solution (LY3074828) in Healthy Participants Mirikizumab - Healthy | Phase 1 | Recruiting | Eli Lilly and Company | 450 | 2026-03-24 | 2026-05-14 |
| Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis Mirikizumab, Azathioprine (AZA) - Ulcerative Colitis (UC) | Phase 4 | Recruiting | University Hospital Schleswig-Holstein | 300 | 2025-12-05 | 2025-12-16 |
| LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: LY4268989, Mirikizumab, LY4268989 Placebo - Ulcerative Colitis | Phase 2 | Recruiting | Eli Lilly and Company | 252 | 2025-11-10 | 2026-10-08 |
| Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis Mirikizumab - Crohn Disease (CD), Crohns Disease | Phase 4 | Not yet recruiting | Rubix LS | 150 | 2025-07-16 | 2025-07-10 |
| Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight Mirikizumab, Tirzepatide, Placebo - Crohn's Disease, Obesity or Overweight | Phase 3 | Recruiting | Eli Lilly and Company | 290 | 2025-06-26 | 2026-10-07 |
| Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study Mirikizumab, Tirzepatide, Placebo - Ulcerative Colitis, Obesity or Overweight | Phase 3 | Recruiting | Eli Lilly and Company | 350 | 2025-06-26 | 2026-10-07 |
| A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis Eltrekibart, Mirikizumab, Placebo - Ulcerative Colitis, Ulcerative Colitis Chronic | Phase 2 | Active not recruiting | Eli Lilly and Company | 143 | 2024-10-10 | 2026-10-07 |
| Association Between Effectiveness of Mirikizumab and UC Patients With High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa Mirikizumab, Vedolizumab - Ulcerative Colitis | Phase 4 | Completed | Showa Inan General Hospital | 100 | 2024-07-20 | 2025-10-20 |
| A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants Citrate-Free Mirikizumab - Healthy | Phase 1 | Completed | Eli Lilly and Company | 498 | 2024-06-24 | 2025-12-30 |
| VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study Vedolizumab (VDZ), Ustekinumab (UST), Risankizumab (RISA) - Crohn's Disease | Active not recruiting | Alimentiv Inc. | 300 | 2024-03-20 | 2026-08-21 | |
| A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease Mirikizumab - Crohn's Disease | Phase 3 | Recruiting | Eli Lilly and Company | 90 | 2024-03-13 | 2026-10-07 |
| A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis Mirikizumab IV, Mirikizumab SC - Ulcerative Colitis | Phase 3 | Completed | Eli Lilly and Company | 63 | 2023-11-22 | 2026-06-03 |
| A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis Mirikizumab - Ulcerative Colitis, Ulcerative Colitis Chronic | Phase 3 | Completed | Eli Lilly and Company | 172 | 2023-05-17 | 2026-06-10 |
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Colitis, Ulcerative (17) · Crohn Disease (13) · Inflammatory Bowel Diseases (7) · Psoriasis (5) · Obesity (2) · Overweight (2) · Breast Feeding (1) · Colitis (1) · Colonic Diseases (1) · Digestive System Diseases (1) · Gastrointestinal Diseases (1) · Intestinal Diseases (1) · Pediatric Crohn's disease (1) · Pediatric ulcerative colitis (1)
Eli Lilly and Company (42) · Alimentiv Inc. (2) · University Hospital Schleswig-Holstein (2) · Icahn School of Medicine at Mount Sinai (1) · Rubix LS (1) · Showa Inan General Hospital (1) · Specialty Networks Research. (1)
United States (41) · Canada (24) · Poland (22) · Germany (21) · Italy (18) · Japan (18) · United Kingdom (17) · Belgium (16) · Hungary (16) · Israel (16) · France (14) · Czechia (13) · Netherlands (12) · South Korea (12) · Spain (12)
Casey Chapman, MD (1) · Nicholas Lazarou, MPH, MBA (1) · Parakkal Deepak, MBBS, MS (1) · Serre-Yu Wong, MD, PhD (1)
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