NCT06733519

TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis

Evaluation of TH104 for Moderate to Severe Pruritus in Primary Biliary Cholangitis: a Double-blind, Randomized, Placebo-controlled, Phase 2a Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tharimmune Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.

Detailed description

Following written informed consent, participants with PBC and pruritus will be screened to establish study eligibility. Eligible participants will participate in a one-week observation period for baseline recording, to train participants in the use of electronic PRO tools, and establish baseline itch scores. Another eligibility assessment will be done at the end of this observation period (i.e., at baseline \[Day 0\]) to ensure that no changes in eligibility have occurred and to confirm that the participant remains eligible. At the baseline visit, participants will be randomized to receive placebo or TH104 treatment. Block randomization will be used, in a 1:2 ratio of placebo:TH104. Treatment will start with a 1-week dose escalation period in which participants will be escalated from 2 mg/day to 4 mg/day TH104 or matching placebo. This will be followed by 2 weeks of treatment with 8 mg and then 3 weeks of 16 mg of TH104 or matching placebo. Following the end of treatment, participants will enter a two-week follow-up period.

Conditions

• Pruritus
• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Nalmefene	Th-104 Nalmefene Mucoadhesive Buccal strip
DRUG	Placebo	Matching placebo to TH-104

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2024-12-13
• Last updated: 2025-09-09

Regulatory

• FDA-regulated drug study