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

NCT06867042 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 72289801
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ulcerative Colitis (UC); Ulcerative Colitis, Active Moderate

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in clinical remission

  Proportion of patients in clinical remission at week 4 will be calculated and reported. The difference between proportions of patients in clinical remission for test treatment and placebo and its 95% confidence interval will be calculated and reported

  Week 4

Study Arms (2)

Tacrolimus Lipid Suspension for Enema

EXPERIMENTAL

Patients will be administered Tacrolimus (4 mg) Lipid Suspension for Enema via rectal route once daily for 28 days

Drug: Tacrolimus Lipid Suspension for enema

Identical Tacrolimus-free Lipid Suspension for Enema

PLACEBO COMPARATOR

Patients will be administered with identical Tacrolimus-free Lipid Suspension for Enema via rectal route once daily for 28 days

Drug: Identical Tacrolimus-free Lipid Suspension for Enema

Interventions

Tacrolimus Lipid Suspension for enema DRUG

Tacrolimus Lipid Suspension for enema 4 mg/vial

Tacrolimus Lipid Suspension for Enema

Identical Tacrolimus-free Lipid Suspension for Enema DRUG

Identical Tacrolimus-free Lipid Suspension for Enema

Identical Tacrolimus-free Lipid Suspension for Enema

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Note: Absence of benefit (inadequate response) is defined as signs and symptoms of persistently active disease despite an adequate trial of induction treatment with an anti-TNF-α agent (per country's approved label); OR recurrence of symptoms during maintenance dosing following prior clinical benefit;
• 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
• Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency when used consistently and correctly during the intervention period and for at least 6 weeks after the last dose of study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.
• A WOCBP must have a negative pregnancy test (serum) at screening and a negative pregnancy test (urine) before the first dose of study intervention.
• Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 weeks after the last dose of study intervention:
• Must agree not to donate sperm for the purpose of reproduction
• PLUS EITHER OF B or C:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR

You may not qualify if:

• 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.
• Treatment that included antibiotic, antifungal, or antiparasitic medications during screening.
• Patients having a history of cancer (defined as malignancy), asthma, or bronchospasm.
• Patients not able to withdraw from treatment or need continuing immunosuppressants for example sirolimus or cyclosporine during the study period.
• Patients with hyperkalemia
• Positive pregnancy test or lactating patients.
• Patients with history or evidence of chemical substance abuse.
• Patients with a history of failure to retain enemas.

Sponsors & Collaborators

• Jina Pharmaceuticals Inc.: lead
• Novum Pharmaceutical Research Services: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Enema

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03