New treatments for adults with ulcerative colitis or Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

A master protocol will support multiple sub-studies that share core design elements. Eligible participants will be assigned to the appropriate sub-study before randomization to a treatment group. The sub-studies aim to test the efficacy and safety of new therapies in adults with moderately to severely active ulcerative colitis or Crohn's disease over at least 62 weeks. Treatments include Mirikizumab given by IV or SC and LY4395089. Eligibility requires confirmed UC or CD with specific activity scores and prior inadequate response or intolerance to standard therapies.

Why it matters

Who can join: the full rules

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.
* 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.
* 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

Where it's running

• Biopharma Informatic, LLC
  Los Angeles, California, United States Recruiting
• Om Research LLC
  Oxnard, California, United States Recruiting
• South Denver Gastroenterology
  Englewood, Colorado, United States Recruiting
• Gastro Health Research - Miami
  Miami, Florida, United States Recruiting
• Ezy Medical Research
  Miami Lakes, Florida, United States Recruiting
• Atlanta Gastroenterology Associates - Peachtree Dunwoody
  Atlanta, Georgia, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
• Email: clinical_inquiry_hub@lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intestinal ultrasound-guided management for inflammatory bowel disease

  This study tests if adding point-of-care intestinal ultrasound at every visit changes treatment decisions for adults with Crohn’s disease or ulcerative colitis undergoing disease assessment.

  Recruiting Mahidol University · Bangkok · NCT07775352

• Guselkumab in Breast Milk for Lactating Women on Guselkumab

  This study tests how much guselkumab is present in the breast milk of lactating women who are already receiving guselkumab for their approved conditions.

  Recruiting Phase 4 Janssen Research & Development, LLC · Chapel Hill, North Carolina · NCT07654751

• Guselkumab use in Crohn's disease and ulcerative colitis

  This study looks at how long people with moderate-to-severe Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen-Cilag Pharma GmbH · Vienna · NCT07606339

• Real-world use of guselkumab in Crohn’s disease and ulcerative colitis

  This study tests how long guselkumab stays in the bodies of adults with moderate-to-severe Crohn’s disease or ulcerative colitis treated in real-world clinical settings.

  Recruiting Janssen-Cilag A.G., Switzerland · Bern · NCT07532213

• Examining the link between polyamine levels and inflammatory bowel disease progression

  This study is trying to see if measuring certain substances in the body can help predict how inflammatory bowel diseases like Ulcerative Colitis and Crohn's Disease will progress in patients.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT06995170

• Using advanced imaging to assess inflammation in bowel diseases

  This study is testing if a new imaging technique can help doctors better see inflammation in patients with Inflammatory Bowel Disease compared to the standard method.

  Recruiting University of Ulm · Ulm, Baden-Wurttemberg · NCT06892990

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.