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TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis

NCT06733519 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-09

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Nalmefene

Th-104 Nalmefene Mucoadhesive Buccal strip

DRUG

Placebo

Matching placebo to TH-104

Sponsors & Collaborators

  • Tharimmune Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-03-01
Completion
2027-06-01
FDA Drug
Yes

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Drugs
Diseases

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 NCT06733519 on ClinicalTrials.gov