Is NCT06997965 recruiting in Salt Lake City, UT?

Yes, NCT06997965 is currently recruiting participants at its Salt Lake City, UT location. This crohn disease clinical trial is actively enrolling qualified participants.

How do I join the crohn disease clinical trial in Salt Lake City?

To join this clinical trial in Salt Lake City, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Salt Lake City clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Crohn Disease Clinical Trial in Salt Lake City, UT

Who Can Participate

Inclusion 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 confirmed centrally by MRE according to the following criteria:

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 anastomosis. Other small bowel strictures will be considered on a case-by-case basis following discussion with the sponsor. Two strictures within 3 cm are considered the same stricture, and a long segment with multiple areas of narrowing or multiple strictures, that have inflammation between them, is counted as 1 stricture.

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 food intake, even with diet modification, defined as a stable weight over 4 weeks prior to initiation of study intervention.

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 study intervention as per standard of care.

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.

Exclusion Criteria

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 colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.

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 cervical carcinoma in situ.

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 interpretation of study results, as determined by the investigator.

Unwillingness to withhold protocol-prohibited medications during the trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Salt Lake City?

Yes, this clinical trial (NCT06997965) has an active research site in Salt Lake City, UT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Crohn Disease Treatment Options in Salt Lake City, UT

If you're searching for crohn disease treatment options in Salt Lake City, UT, this clinical trial (NCT06997965) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Salt Lake City research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced crohn disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all crohn disease clinical trials near you to find additional studies recruiting in your area.

Crohn Disease Clinical Trial in Salt Lake City, UT

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About This Crohn Disease Study in Salt Lake City