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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-12

No results posted yet for this study

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

Interventions

DRUG

Tacrolimus Lipid Suspension for enema

Tacrolimus Lipid Suspension for enema 4 mg/vial

DRUG

Identical Tacrolimus-free Lipid Suspension for Enema

Identical Tacrolimus-free Lipid Suspension for Enema

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Jina Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2026-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867042 on ClinicalTrials.gov