Ulcerative Colitis study: Mirikizumab vs Azathioprine
Official title Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT07235904
What this study is testing
What is Mirikizumab?
Mirikizumab is an investigational medicine being studied as a potential treatment for ulcerative colitis. It is designed to block a specific protein in the body that causes inflammation in the intestines.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if starting treatment with mirikizumab right away is more effective than the usual first step of using azathioprine.
- Who it's for
- People newly diagnosed with moderate to severe ulcerative colitis in the last year who did not get enough relief from mesalazine and prednisolone.
- What's involved
- Participants are randomly assigned to receive either mirikizumab injections or daily azathioprine tablets with steroids. Mirikizumab starts with IV infusions at the clinic, then moves to home injections.
- Time commitment
- The study lasts 52 weeks, involving an initial 12-week treatment period followed by 40 weeks of maintenance therapy.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Have given written informed consent prior to any study-specific procedures being completed.
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- Are willing to comply with contraception requirements (as specified in section 7.7)
- Age between 18 and 75 years.
- Naïve to azathioprine and its metabolite 6-MP
You likely can't join if
- Fulminant ulcerative colitis patients who do not respond to steroid treatment or requiring \>20 mg of prednisolone (or equivalent) at baseline and/or...
- Patients with complex UC who have required cyclosporine and tacrolimus for previous treatment
- Treatment with MTX within 8 weeks before baseline
- Rectal 5-ASA or rectal steroids treatment within 2 weeks prior to baseline
- History of malignancy, except for non-melanoma skin cancer.
- Planned or foreseeable surgery at the time of inclusion.
See the full eligibility criteria
- Have given written informed consent prior to any study-specific procedures being completed.
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- Are willing to comply with contraception requirements (as specified in section 7.7)
- Age between 18 and 75 years.
- Naïve to azathioprine and its metabolite 6-MP
- Naïve to advanced therapies.
- Early disease (duration \< 12 months since first diagnosis).
- Patients with active ulcerative colitis (UC) for whom a previous therapy with 5-aminosalicylic acid (5-ASA) or steroids have not worked well enough, have stopped working, or have caused unacceptable side effects.
- The steroid oral therapy must have been stable for at least two weeks before baseline and may consist of prednisone ≤20 mg/day (or equivalent) per os.
- The oral 5-ASA therapy must have been ongoing for at least 8 weeks and dose must be stable for at least 2 weeks before baseline.
- Modified Mayo score (mMS) 5-9.
- Endoscopic Mayo (eMayo) score ≥2 (local).
- Robarts Histopathology Index (RHI) \>4 (central)
- Elevated CRP (above the upper limit of normal) or Fcal (above 250 ug/g stool).
- Disease localization involving at least the rectum and sigmoid colon (\>15 cm).
- Fulminant ulcerative colitis patients who do not respond to steroid treatment or requiring \>20 mg of prednisolone (or equivalent) at baseline and/or fulfilling the criteria for severe UC (requirement of...
- Patients with complex UC who have required cyclosporine and tacrolimus for previous treatment
- Treatment with MTX within 8 weeks before baseline
- Rectal 5-ASA or rectal steroids treatment within 2 weeks prior to baseline
- History of malignancy, except for non-melanoma skin cancer.
- Planned or foreseeable surgery at the time of inclusion.
- Known thiopurine methyltransferase deficiency.
- Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- Diagnosis of Crohn's disease.
- Have been diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB).
- Have detectable hepatitis B virus (HBV) DNA. or hepatitis C virus (HCV) RNA
- Have been diagnosed with latent TB and are not willing to comply with completing TB treatment as appropriate.
- Intend to receive a Bacillus Calmette-Guerin (BCG) vaccination or live attenuated vaccine(s) during the study.
- Have been diagnosed with systemic mycoses and parasitosis
- Have an unstable or uncontrolled illness, including, but not limited to, cerebrocardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic or neurological disorders or...
- Have a known systemic hypersensitivity to any component of this investigational product or has experienced an acute systemic hypersensitivity event with previous study drug administration, that precludes mirikizumab...
- Women who are pregnant, lactating or planning pregnancy
- Became a Lilly employee or employee of any of the organizations involved with this study or study site personnel directly affiliated with this study and/or their immediate families.
- Have participated in another clinical trial involving an investigational product or nonapproved use of a drug during the last twelve weeks before screening or are currently enrolled in any other clinical study involving...
- Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient daily for the duration of Study MIRACLE or are unable to complete other study procedures.
- Have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
The study team makes the final eligibility decision.
Where it is enrolling
- Kiel, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kiel, Germany. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.