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

NCT07483073 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

DRUG

Mirikizumab - Intravenous (IV)

Administered IV

DRUG

Mirikizumab - Subcutaneous (SC)

Administered SC

DRUG

LY4395089

Administered orally

Sponsors & Collaborators

Principal Investigators

  • Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-04
Primary Completion
2027-06-30
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • China
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07483073 on ClinicalTrials.gov