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New treatment option for Pouchitis
Official title Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
ClinicalTrials.gov ID: NCT06864403
What this study is testing
What is Mirikizumab - Intravenous (IV)?
Mirikizumab - Intravenous (IV) is an investigational medicine, being studied as a potential treatment for pouchitis.
Also referred to as Omvoh.
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
- The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are: Does mirikizumab reduce symptoms of pouch disorders Participants will: Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
- Phase 4: studies an already-approved treatment
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 80
You may be able to join if
- Informed consent will be obtained before any study-related procedures
- Age \>/= 18 and \</= 80 years
- Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:
- Chronic Antibiotic-Dependent Pouchitis: Recurrent symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic...
- Chronic Antibiotic Refractory Pouchitis: Lack of response to standard antibiotic therapy, requirement of a longer duration of antibiotic therapy than...
You likely can't join if
- Prior exposure to mirikizumab
- Known hypersensitivity to mirikizumab or its metabolites
- Current infection with Clostridioides difficile
- Known HIV or active Hepatitis B/C
- Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \<1.5 upper limit of normal can be included)
- Severe hepatic impairment, defined as Child-Pugh Class C
See the full eligibility criteria
- Informed consent will be obtained before any study-related procedures
- Age \>/= 18 and \</= 80 years
- Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:
- Chronic Antibiotic-Dependent Pouchitis: Recurrent symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort) that respond to antibiotic therapy but relapse shortly after...
- Chronic Antibiotic Refractory Pouchitis: Lack of response to standard antibiotic therapy, requirement of a longer duration of antibiotic therapy than expected with minimal improvement in symptoms, in association with...
- Crohn's-like disease of the pouch: Presence of a perianal or other fistula that developed at least 12 months after the final stage of Ileal Pouch Anal Anastomosis (IPAA) surgery, stricture of the pouch body or pre-pouch...
- Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown
- Ability to access internet for electronic database entry
- Only those individuals for whom a provider is considering initiating mirikizumab for the treatment of chronic pouchitis or Crohn's-like disease of the pouch will be eligible for participation.
- Prior exposure to mirikizumab
- Known hypersensitivity to mirikizumab or its metabolites
- Current infection with Clostridioides difficile
- Known HIV or active Hepatitis B/C
- Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \<1.5 upper limit of normal can be included)
- Severe hepatic impairment, defined as Child-Pugh Class C
- Known decreased kidney function with a glomerular filtration rate \<45 ml/min/1.732
- History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence.
- Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
- Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Rochester, Minnesota, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.