A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)

Phase 2

Recruiting

• Conditions: Alcohol Hepatitis
• Interventions: Drug: ADX-629

• Registration Number: NCT06685692
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief Summary

A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-04
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult ≥ 21 years old on the day of signing the informed consent form;
• Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening
• Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment
• Ability and willingness to swallow tablets
• Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements

Exclusion Criteria

• Pregnant, intending to become pregnant (or father a child), or breastfeeding
• Current or recent enrollment in another interventional trial in the 30 days prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADX-629 (125 mg twice daily)	ADX-629	-
ADX-629 (250 mg twice daily)	ADX-629	-

Primary Outcome Measures

Name	Time	Method
Treatment-Emergent Adverse Event Query	Day 1 to Day 28	Incidence and severity of treatment-emergent adverse events

Trial Locations

Locations (6)

Florida Health Sciences Center/Tampa General Hospital/USF; 🇺🇸 Tampa, Florida, United States

The Liver Institute at Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States

UDL Clinical Research, LLC; 🇺🇸 Houston, Texas, United States

Methodist Specialty and Transplant Hospital; 🇺🇸 San Antonio, Texas, United States

Bon Secours Liver Institute of Newport News; 🇺🇸 Richmond, Virginia, United States

Synergry Healthcare; 🇺🇸 Bradenton, Florida, United States