Crohn'sUCNot yet recruiting
Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis
Phase 4 · Testing Mirikizumab · 1 site · Rubix LS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Mirikizumab (a biologic) as a possible treatment. Condition(s) listed: Crohn Disease (CD), Crohns Disease and Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 60 to 99
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2025-07-16 (planned).
- Main results expected around 2026-01-01 (estimate from the record).
- 1 study site listed in United States.
Main thing being measured
- Clinical Remission at Week 24 (24 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Crohns Disease; Ulcerative Colitis (UC) |
| Lead sponsor | Rubix LS |
| Collaborators | Eli Lilly and Company |
| Enrollment | 150 (estimated) |
| Start date | 2025-07-16 |
| Primary completion (est.) | 2026-01-01 |
| First posted | 2025-07-10 |
| Last updated | 2025-07-10 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07059130 |
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Rubix LS | Lawrence, Massachusetts | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.