A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease

Lilly

Status and phase: Begins enrollment this month; Phase 2

Conditions: Colitis, Ulcerative; Crohn Disease

Treatments: Drug: Mirikizumab - Subcutaneous (SC); Drug: LY4395089; Drug: Mirikizumab - Intravenous (IV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07483073

2025-524112-11-00 (EU Trial (CTIS) Number)

27807

J6Z-MC-CD01 (Other Identifier)

J6Z-MC-IIBD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mirikizumab

Active Comparator group

Description:

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

Treatment:

Drug: Mirikizumab - Intravenous (IV)

Drug: Mirikizumab - Subcutaneous (SC)

LY4395089 and Mirikizumab Co-Administration

Experimental group

Description:

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

Treatment:

Drug: Mirikizumab - Intravenous (IV)

Drug: LY4395089

Drug: Mirikizumab - Subcutaneous (SC)