Recruiting
Phase 2

Ulcerative Colitis

Sponsor:

Eli Lilly and Company

Code:

NCT07483073

Conditions

Colitis, Ulcerative

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mirikizumab - Intravenous (IV)

Mirikizumab - Subcutaneous (SC)

LY4395089

Study Details

Brief summary:

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

Conditions

Colitis, Ulcerative

Crohn Disease

Study ID

NCT07483073

Start date

May 4, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.
  • For UC:

  • Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.
  • For CD:

  • Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization
  • Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD
  • Have screening laboratory test results within the protocol specified parameters.

Exclusion Criteria:

  • Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis

  • For UC - must not have a current diagnosis of CD
  • For CD - must not have a current diagnosis of UC
  • Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
  • Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome
  • Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data
  • Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action
  • Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment
  • Must not have received or will need any prohibited medications for UC or CD as specified in the protocol

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mirikizumab

Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.

experimental: LY4395089 and Mirikizumab Co-Administration

Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.

Interventions

Mirikizumab - Intravenous (IV)

Administered IV

Mirikizumab - Subcutaneous (SC)

Administered SC

LY4395089

Administered orally

Primary outcome measure

  • Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA) [ Time Frame: Baseline, Up to Day 42 ]

Central Contacts and Locations

Central contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559clinical_inquiry_hub@lilly.com

Locations

Biopharma Informatic, LLC

Recruiting

Los Angeles, California, United States, 90035

Contacts

281-944-3610

Principal Investigator:

Morris Silver, MD

Om Research LLC

Recruiting

Oxnard, California, United States, 93030

Contacts

661-388-2239

Principal Investigator:

Karen Simon

South Denver Gastroenterology

Recruiting

Englewood, Colorado, United States, 80113

Principal Investigator:

Marcelo Kugelmas

Gastro Health Research - Miami

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Lukasz Kwapisz

Ezy Medical Research

Recruiting

Miami Lakes, Florida, United States, 33015

Contacts

786-483-8162

Principal Investigator:

Hendry Perez-Pascual

Atlanta Gastroenterology Associates - Peachtree Dunwoody

Recruiting

Atlanta, Georgia, United States, 30342

Principal Investigator:

Nitin Gupta

Cotton O'Neil Digestive Health Center

Recruiting

Topeka, Kansas, United States, 66606

Contacts

785-368-0477

Principal Investigator:

Curtis Baum

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

Recruiting

Wyoming, Michigan, United States, 49519

Principal Investigator:

Allan Coates

KAD Clinical Research

Recruiting

St Louis, Missouri, United States, 63123

Contacts

314-254-3168

Principal Investigator:

Adrian Di Bisceglie

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-750-0000

Principal Investigator:

Christian Stone

Southern Star Research Institute

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-581-2812

Principal Investigator:

Jeff Bullock

Tdda Inc.

Recruiting

Vaughan, Canada, L4L 4Y7

Contacts

14166500017

Principal Investigator:

David Ford

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.