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NCT07059130 · ClinicalTrials.gov registry record · Phase 4
Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis
A Phase 4 study, sponsored by Rubix LS.
- Not yet
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT07059130: Clinical Trial Phase 4 study, sponsored by Rubix LS.
NCT07059130 is a Phase 4 study that has not yet begun recruiting, run by Rubix LS. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07059130, a Phase 4 study, has not yet begun recruiting, sponsored by Rubix LS.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical remission is defined as achieving either: Crohn's Disease Activity Index (CDAI) score less than 150 (for participants with Crohn's Disease), or Mayo Score of 2 or less (for participants with Ulcerative Colitis).
Interventions
- BIOLOGICAL Mirikizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 4 |
What is known before NCT07059130 opens enrollment
NCT07059130 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Mirikizumab is the first listed.
NCT07059130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07059130 about?
NCT07059130 is a clinical study titled "Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis". 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 (swelli...
What is the current status of trial NCT07059130?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2025-07-16. Estimated completion is 2026-02-28.
What interventions are being tested in trial NCT07059130?
The interventions under investigation include: Mirikizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07059130?
This trial is sponsored by Rubix LS, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07059130's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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