Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWashington University School of Medicine
About this trial
The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects 18 to 80 years of age, inclusive, at the time of consent
Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
Active ileal or ileocolonic inflammation on colonoscopy defined as
Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids.
Disqualifiers
Age < 18 or > 80 years
Pregnant or Breastfeeding female
Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening
BMI < 25
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugAddition of tirzepatide to current biological therapy
Standard of care treatment
DrugIntervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Tirzepatide groupExperimental treatment 1 intervention
Group B: Standard of Care ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0
Time frame
From enrollment to the end of treatment at month 72
Number of participants who achieve various doses of Tirzepatide at increments of 2.5 mg, up to 15 mg
Time frame
From enrollment to the end of treatment at month 73
Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1.
Time frame
From enrollment to the end of treatment at month 7Secondary outcomes
1
Proportion and number of participants with endoscopic response as defined by (↓SES-CD 50%)
Time frame
From enrollment to the end of treatment at month 72
Proportion and number of participants who achieve clinical remission/response defined by Crohn's disease activity index < 150 for clinical remission or a decrease from baseline by at least 100 points on CDAI
Time frame
From enrollment to the end of treatment at month 73
Proportion and number of participants who achieve clinical remission defined by a Harvey Bradshaw Index < 5
Time frame
From enrollment to the end of treatment at month 74
Proportion and number of participants who achieve improvement from baseline in the Short Inflammatory Bowel Disease Quality of Life Questionnaire in four domains, bowel symptoms, emotional health, systemic systems and social function. Questions are score
Time frame
From enrollment to the end of treatment at month 7Sponsors and contacts
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Source ClinicalTrials.gov