BridgeMD
New treatment option for Crohn Disease (CD)
Official title Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
ClinicalTrials.gov ID: NCT06976853
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, being studied as a potential treatment for crohn disease (cd).
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 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.
- Phase 2: a mid-size study of how well it works
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
- people 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 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm)
- Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must...
- Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab
You likely can't join if
- Age \ 80 years
- Pregnant or Breastfeeding female
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated...
- BMI \< 25
- Current or previous diagnosis of anorexia nervosa
- Type 1 or Type 2 diabetes
See the full eligibility criteria
- people 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 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm)
- 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...
- Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab
- Anti-integrin agent: vedolizumab
- Anti-IL12/23 agent: Ustekinumab
- Anti-IL23: Risankizumab, Guselkumab, Mirikizumab
- JAK inhibitor: Upadacitinib
- In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease
- In females: compliance to recommended birth control requirements
- Age \ 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...
- BMI \< 25
- Current or previous diagnosis of anorexia nervosa
- Type 1 or Type 2 diabetes
- Use of concomitant hypoglycemic agents
- Personal or family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia
- Known serious hypersensitivity to tirzepatide or any of its excipients
- Have functional or post-operative short-bowel syndrome
- Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion
- Active treatment with steroids\
- Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment
- Current stricture not passable with an endoscope
- Impending need for surgery per investigator
- Have an ileostomy or a colostomy
- In females: refusal to comply to recommended birth control requirements \ Corticosteroids have metabolic and hormonal effects which we are concerned may interfere with study outcomes and metabolic changes in the...
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- St Louis, Missouri, United States
- New York, New York, 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 Beverly Hills, California, United States; St Louis, Missouri, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.