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

Launched by RUBIX LS · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called Mirikizumab to see how well it works and how safe it is for adults aged 60 and older who have moderate to severe Crohn’s disease or ulcerative colitis. These are conditions that cause inflammation and irritation in the digestive system, leading to symptoms like stomach pain, diarrhea, and tiredness. Since older adults often have other health problems, it’s important to understand if Mirikizumab can help them manage their symptoms safely. Although this medicine is already approved for adults with these conditions, this study focuses specifically on how it affects older adults.

People who are 60 or older and have a confirmed diagnosis of moderate to severe Crohn’s disease or ulcerative colitis may be eligible to join. Participants will receive Mirikizumab following the usual treatment plan approved by the FDA. The main goal is to see how many people experience significant improvement or complete relief of their symptoms after 24 weeks, and whether these benefits last up to 48 weeks. The study will also check how well participants do without needing steroids, look at blood tests for inflammation, and ask participants about how they feel overall. Safety is a top priority, so researchers will watch closely for any side effects during the study. This trial hopes to provide useful information to help older adults and their doctors make better choices about treating these conditions.

Gender

ALL

Eligibility criteria

• 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.