Not Yet RecruitingPhase 4

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

United States150 participantsStarted 2025-07-16

Plain-language 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.

Who can participate

Age range60 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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. Exclusion Criteria: 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.

What they're measuring

Clinical Remission at Week 24

Timeframe: 24 weeks

Trial details

NCT IDNCT07059130

SponsorRubix LS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-01