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Tests treatment safety and results for Crohn Disease
Official title Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
ClinicalTrials.gov ID: NCT06997965
What this study is testing
What is Mirikizumab?
Mirikizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn disease.
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
- This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.
- Phase 4: studies an already-approved treatment
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Nonpregnant, nonlactating adults, ≥ 18 years of age.
- Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to...
- Presence of at least 1 inflammatory stricture in the terminal ileum\ within reach of an endoscope (passable or nonpassable). Strictures should be...
- Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); AND
- Bowel wall thickening (≥ 25% relative to adjacent bowel; AND
You likely can't join if
- History or current diagnosis of UC, indeterminate colitis, ischemic colitis, nonsteroidal anti inflammatory drug-induced colitis, idiopathic colitis...
- CD-related complications:
- Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.
- Short bowel syndrome.
- Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
- Inactive fistulae in or adjacent to an ileal stricture. Participants with perianal fistulae could be included provided there is no evidence of...
See the full eligibility criteria
- Nonpregnant, nonlactating adults, ≥ 18 years of age.
- Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening.
- Presence of at least 1 inflammatory stricture in the terminal ileum\ within reach of an endoscope (passable or nonpassable). Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and...
- Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); AND
- Bowel wall thickening (≥ 25% relative to adjacent bowel; AND
- Either prestenotic dilation (defined as a luminal diameter ≥ 3 cm) or nonpassable with adult colonoscope \ Note: The terminal ileum is defined as the last 15 cm of ileum proximal to the ileocecal valve or ileocolonic...
- Abdominal pain after eating and/or limitations in the amount/types of food eaten.
- Presence of tolerable obstructive symptoms and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study period. Participants should have sufficient...
- Participants taking oral corticosteroids (eg, ≤ 20 mg/day prednisone or ≤ 9 mg/day budesonide) for ≥ 4 weeks prior to screening. Participants must be willing to undergo corticosteroid taper 8 weeks after initiation of...
- Participants can be on stable background therapy for CD and must agree to maintain the background therapy during the study. Acceptable stable background therapies include:
- Oral 5-ASA drugs or sulfasalazine ≤ 4.8 g per day, for ≥ 4 weeks prior to screening
- AZA, 6-MP, or MTX for ≥ 4 weeks prior to Screening
- Any rectal therapy for treatment of CD for ≥ 4 weeks prior to screening
- Antidiarrheal drugs for ≥ 8 weeks prior to screening
- Bile acid sequestrants for ≥ 4 weeks prior to screening
- Contraceptive use by study participants should be in accordance with the mirikizumab product monograph and local guidelines.
- Signed informed consent.
- History or current diagnosis of UC, indeterminate colitis, ischemic colitis, nonsteroidal anti inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic...
- CD-related complications:
- Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.
- Short bowel syndrome.
- Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
- Inactive fistulae in or adjacent to an ileal stricture. Participants with perianal fistulae could be included provided there is no evidence of peri-anal abscess \> 2 cm.
- Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated.
- Abscess located \< 2 cm in relation to the stricture.
- Toxic megacolon.
- Any major surgery, in the investigator's opinion, performed within 8 weeks prior to screening or planned during the study (ie, any surgical procedure requiring general anesthesia).
- Malignancies or history of malignancy within 5 years of the initial screening visit, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or...
- Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury.
- Liver chemistry parameters that exceed the following thresholds:
- ALT or AST \> 2 × ULN
- Alkaline phosphatase \> 2.5 × ULN
- Total bilirubin \> 1.5 × ULN
- Concomitant use of the following medications during the screening period or throughout the study:
- Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening.
- Biologics (anti-tumor necrosis factor, anti-integrins, ustekinumab, or risankizumab) within 8 weeks prior to screening.
- JAK inhibitor within 4 weeks prior to screening and throughout the study.
- IL23p19 inhibitor within 4 weeks (or 5 half-lives, whichever is longer) prior to screening, or a history of nonresponse or intolerance to IL23p19 inhibitors.
- Not up-to-date with current age-appropriate vaccinations in accordance with current immunization guidelines and the investigator's usual standard of care at screening.
- Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening.
- Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies.
- Systemic or opportunistic infections including:
- HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to Day 0, retesting is not required.
- Known active or latent TB; if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before Day 0.
- Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin).
- Active CMV infection, as per investigator judgement
- Other systemic or opportunistic infection, any other clinically significant extraintestinal infection, infection that is not responding to standard treatment, or recurring infection within 6 months of Day 1.
- Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients.
- Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic.
- Prior enrolment in the current study and had received study treatment.
- Any acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study intervention administration, or may interfere with the...
- Unwillingness to withhold protocol-prohibited medications during the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Salt Lake City, Utah, United States
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Scarborough Village, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Salt Lake City, Utah, United States; Vancouver, British Columbia, Canada; London, Ontario, Canada; Scarborough Village, Ontario, Canada. 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.