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

Part of paid clinical trials in Lawrence, Massachusetts.

Sponsor
Rubix LS
Study ID
NCT07059130
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 99 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 16, 2025
Status verified
Jul 2025
Primary completion
Jan 1, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mirikizumab Treatment Group
    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.

Primary Outcome Measure

Clinical Remission at Week 24 [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rubix LSLawrenceMassachusetts01840
Tara C Mitchell, PhD
[email protected]
978-552-3183

Find similar trials in Lawrence, MA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Rubix LS· Lawrence, MA

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