NCT06867042

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

A Double-blind, Randomized, Multicenter, Parallel, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety and Tolerability of 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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jina Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-03-10
• Last updated: 2025-03-12

Regulatory

• FDA-regulated drug study