Tacrolimus Lipid Suspension for Enema in Adult Subjects with Mild to Moderately Active Left-sided… (NCT06867042) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Tacrolimus Lipid Suspension for Enema in Adult Subjects with Mild to Moderately Active Left-sided/Distal Ulcerative Colitis Who Had an Inadequate Response to the Treatment
150 participantsStarted 2025-04
Plain-language summary
The study will evaluate the effectiveness, safety and tolerability of tacrolimus lipid suspension for enema in adult patients with mild to moderately active ulcerative colitis who had an inadequate response or intolerance of at least 1 of aminosalicylates (5-ASAs), corticosteroids, azothiopurine, mercaptopurine and methotrexate and need an alternative therapy. There will be approximately 150 male and female subjects of 18 and 65 years of age enrolled. Patients will be randomized into two groups where Tacrolimus Lipid Suspension for Enema or Placebo (Tacrolimus-free) Lipid Suspension for Enema will be administered rectally once daily for 28 days.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients ≥ 18 years and ≤ 65 years of age.
. Patients have a documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria involving the whole or part of the left side of the colon \[approximately 60 cm up from the anus (anal verge) to splenic flexure of colon\], with mild to moderate active disease.
. Patients with a score of at least 4 on the modified Mayo Score (mMS), including an endoscopy subscore of at least 2 and a rectal bleeding subscore of at least 1.
. Patients who have inadequate response, loss of response, or intolerance of at least 1 of aminosalicylates (5-ASAs) (mesalamine, sulfasalazine, olsalazine, basalazide), corticosteroids, azothiopurine, mercaptopurine and methotrexate and need an alternative therapy as per the discretion of the Investigator.
. Patients who have failed to achieve total resolution of all symptoms to topical and/or oral standard treatment regimen of aminosalicylates (mesalamine, sulfasalazine, olsalazine, basalazide) or corticosteroids, azathioprine, mercaptopurine and methotrexate over minimum 4-week duration and need an alternative therapy as per the discretion of the Investigator. Determination of the outcomes of prior therapies should be made after the completion of at least one induction regimen and one maintenance regimen, as appropriate, for the prior therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The patients who do not show evidence of benefits with the use of Biologics (e.g. Anti-integrins, Anti-TNFalpha and Anti-interleukins) for ulcerative colitis can be enrolled in the study. However, after a washout duration of 5 half-lives from any prior biologic treatments prior to enrollment is required. A shorter washout duration (e.g., 3 half-lives) is acceptable if undetectable drug levels of the biologic can be demonstrated.
. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
. Is not a woman of childbearing potential (WOCBP) OR
Exclusion criteria
. Documented history of proximal or universal ulcerative colitis (pan colitis).
. Patients who receive mMS score of 8 or greater (severe disease)
. Patients with known allergy to study drugs or have a history of serious AEs related to their use.
. Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
. Prior documented history of high-grade dysplasia on biopsy from endoscopic examinations.
. Presence of enteric pathogens or Clostridium difficile toxins in stool samples.
. History of recurrent Clostridium difficile infection.
. Patients who received systemic steroids or immunosuppressants within the previous 4 weeks of screening.