Crohn Disease (CD)Phase 4NCT07059130
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 testing Mirikizumab in people with Crohn Disease (CD) and Crohns Disease, run by Rubix LS at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Crohn Disease (CD), Crohns Disease, Ulcerative Colitis (UC)
- What is being tested?
- Mirikizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rubix LS
Lawrence, Massachusetts, 01840
Tara C Mitchell, PhD, 978-552-3183, tcassineau@rubixls.com
About this study
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
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.
Read more
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.
Read the detailed description
This study is a Phase IV clinical trial designed specifically to examine how older adults (aged 60 years and above) respond to Mirikizumab, a biologic treatment approved by the FDA for inflammatory bowel disease (IBD). Recognizing the limited clinical trial representation of older patients, this study aims to provide essential evidence on treatment effectiveness, safety, and patient experience within this specific age group, addressing an existing knowledge gap in clinical practice.
The trial will enroll approximately 150 adult participants diagnosed with moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) across multiple academic and community healthcare settings within the United States. Enrolled participants will undergo treatment with Mirikizumab administered strictly in accordance with FDA-approved dosing guidelines, without comparator or placebo groups.
Key measures of clinical improvement include standardized, validated scoring systems: the Crohn's Disease Activity Index (CDAI) for CD participants and the Mayo Score for UC participants. 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.
Participants will attend scheduled visits at baseline (Week 0), and subsequently at Weeks 12, 24, and 48. At each visit, researchers will assess clinical status, collect biological samples for biomarker analysis, review patient-reported outcomes, and systematically document any side effects or adverse events associated with treatment.
Safety will be carefully monitored by an independent Data Monitoring Committee (DMC), which will review collected safety data semi-annually. Procedures for adverse event reporting are rigorous, following strict regulatory guidelines to ensure participant safety.
Comprehensive strategies to retain and support study participants include regular follow-up contacts, adherence monitoring, patient education initiatives, and flexible scheduling for convenience.
Data collected throughout the trial will be securely managed using electronic data capture systems with strict confidentiality and quality control protocols in place. Statistical analyses will involve standard intention-to-treat (ITT) methods and mixed-model statistical approaches to accurately determine treatment effectiveness and safety outcomes.
Ultimately, the findings from this trial aim to inform clinical care guidelines for older adults with IBD and enhance clinical decision-making by providing robust, real-world evidence specific to the aging population.
- Conditions
- Crohn Disease (CD), Crohns Disease, Ulcerative Colitis (UC)
- Being tested
- Mirikizumab
- Keywords
- Mirikizumab, Crohn's Disease, Ulcerative Colitis, Clinical remission, Elderly, Biomarkers, IBD
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabBiological
Also called Mirikizumab Treatment Group
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 group | Role | What they receive |
|---|---|---|
| Mirikizumab Treatment Group | Experimental | 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. Receives: Biological: Mirikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission at Week 24
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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start16 Jul 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rubix LS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059130
- Sponsor's protocol ID
- REX201233
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing is currently undecided. Any future requests for data sharing will be carefully considered and reviewed by the sponsor (Rubix LS) on a case-by-case basis, taking into account the nature of the request, ethical considerations, privacy of study participants, and potential scientific value of data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- REX201233
- Conditions
- Crohn Disease (CD), Crohns Disease, Ulcerative Colitis (UC)
- Keywords
- Mirikizumab, Crohn's Disease, Ulcerative Colitis, Clinical remission, Elderly, Biomarkers, IBD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rubix LSIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 16 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Phase IV clinical trial designed specifically to examine how older adults (aged 60 years and above) respond to Mirikizumab, a biologic treatment approved by the FDA for inflammatory bowel disease (IBD). Recognizing the limited clinical trial representation of older patients, this study aims to provide essential evidence on treatment effectiveness, safety, and patient experience within this specific age group, addressing an existing knowledge gap in clinical practice.
The trial will enroll approximately 150 adult participants diagnosed with moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) across multiple academic and community healthcare settings within the United States. Enrolled participants will undergo treatment with Mirikizumab administered strictly in accordance with FDA-approved dosing guidelines, without comparator or placebo groups.
Key measures of clinical improvement include standardized, validated scoring systems: the Crohn's Disease Activity Index (CDAI) for CD participants and the Mayo Score for UC participants. 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.
Participants will attend scheduled visits at baseline (Week 0), and subsequently at Weeks 12, 24, and 48. At each visit, researchers will assess clinical status, collect biological samples for biomarker analysis, review patient-reported outcomes, and systematically document any side effects or adverse events associated with treatment.
Safety will be carefully monitored by an independent Data Monitoring Committee (DMC), which will review collected safety data semi-annually. Procedures for adverse event reporting are rigorous, following strict regulatory guidelines to ensure participant safety.
Comprehensive strategies to retain and support study participants include regular follow-up contacts, adherence monitoring, patient education initiatives, and flexible scheduling for convenience.
Data collected throughout the trial will be securely managed using electronic data capture systems with strict confidentiality and quality control protocols in place. Statistical analyses will involve standard intention-to-treat (ITT) methods and mixed-model statistical approaches to accurately determine treatment effectiveness and safety outcomes.
Ultimately, the findings from this trial aim to inform clinical care guidelines for older adults with IBD and enhance clinical decision-making by providing robust, real-world evidence specific to the aging population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab Treatment Group | Experimental | Biological: MirikizumabParticipants 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. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirikizumabAlso: Mirikizumab Treatment GroupMirikizumab 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. | Biological | Mirikizumab Treatment Group |
Primary outcome
Clinical Remission at Week 24
Time frame: 24 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing is currently undecided. Any future requests for data sharing will be carefully considered and reviewed by the sponsor (Rubix LS) on a case-by-case basis, taking into account the nature of the request, ethical considerations, privacy of study participants, and potential scientific value of data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirikizumab in people with Crohn Disease (CD) and Crohns Disease, run by Rubix LS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission at Week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.