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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

Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis: A Phase IV Multicenter Interventional Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Additionally, validated biomarkers indicative of disease activity (e.g., CRP, fecal calprotectin) and standardized patient-reported outcome measures (Inflammatory Bowel Disease Questionnaire \[IBDQ\]) will be evaluated at specified intervals."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

MA