Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis

NCT07059130 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: REX201233
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This research study looks at how safe and effective a medicine called Mirikizumab is for treating older adults (aged 60 and above) who have moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). These two conditions, known as inflammatory bowel diseases (IBD), cause inflammation (swelling and irritation) in the digestive tract. Older adults with these conditions often have other health issues and face increased risks and complications, making it challenging for them to use certain treatments. Mirikizumab is already approved by the FDA for adults with IBD, but there's limited information about how well it works specifically for older adults. This study aims to fill that gap by seeing if Mirikizumab can help these patients safely manage their condition. The study plans to enroll around 150 people from various locations across the United States. Everyone participating will receive Mirikizumab according to the standard, FDA-approved guidelines. The main goal is to see how many participants achieve clinical remission, meaning their symptoms significantly improve or disappear, after 24 weeks of treatment. Researchers will also look at whether this remission lasts up to 48 weeks, how well symptoms are controlled without steroids, how treatment affects indicators of inflammation (such as blood tests), and how the participants feel overall based on their own reports. The safety of Mirikizumab will also be closely monitored throughout the study by regularly checking for any side effects. This study hopes to provide clearer information to help older adults with IBD and their doctors make better treatment decisions, ultimately improving health outcomes and quality of life.

Conditions

Crohn Disease (CD); Crohns Disease; Ulcerative Colitis (UC)

Keywords

Mirikizumab; Crohn's Disease; Ulcerative Colitis; Clinical remission; Elderly; Biomarkers; IBD

Outcome Measures

Primary Outcomes (1)

• Clinical Remission at Week 24

  Clinical remission is defined as achieving either: Crohn's Disease Activity Index (CDAI) score less than 150 (for participants with Crohn's Disease), or Mayo Score of 2 or less (for participants with Ulcerative Colitis).

  24 weeks

Study Arms (1)

Mirikizumab Treatment Group

EXPERIMENTAL

Participants aged 60 years and older with moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) will receive Mirikizumab administered according to FDA-approved dosing guidelines. All enrolled participants will be assigned to this single intervention group for the entire study duration.

Biological: Mirikizumab

Interventions

Mirikizumab BIOLOGICAL

Mirikizumab will be administered to participants according to FDA-approved dosing guidelines for moderate-to-severe Crohn's Disease and Ulcerative Colitis. Participants will receive scheduled doses throughout the study period at predefined intervals. Clinical assessments, patient-reported outcomes, biomarker analyses, and safety monitoring will occur at baseline and at Weeks 12, 24, and 48.

Also known as: Mirikizumab Treatment Group

Mirikizumab Treatment Group

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 60 years or older at the time of enrollment.
• Diagnosed with moderate-to-severe Crohn's Disease (CDAI score ≥220) or moderate-to-severe Ulcerative Colitis (Mayo Score ≥6).
• Capable of providing informed consent for participation in the study.

You may not qualify if:

• History of recent major gastrointestinal surgery within 3 months prior to enrollment.
• Active infection requiring antibiotic or antiviral treatment at the time of enrollment.
• Active malignancy or a history of malignancy within the past 5 years. (Exception: Participants with fully resected basal cell carcinoma or squamous cell carcinoma of the skin, with no metastatic disease for at least 3 years, are eligible.)
• Current use or recent participation (within 30 days) in another clinical trial involving investigational therapies.
• Contraindication or known hypersensitivity to biologic medications, specifically Mirikizumab.
• Active cardiovascular disease, including:
• Unstable angina, myocardial infarction, or cardiovascular procedures within the past 6 months.
• Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg despite treatment).
• Congestive heart failure (NYHA Class III or IV).
• Clinically significant arrhythmias or other unstable cardiovascular conditions.

Sponsors & Collaborators

• Rubix LS: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Rubix LS

Lawrence, Massachusetts, 01840, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: July 16, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 28, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (1)