NCT06146101

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA

A Phase II/III, Randomised, Double-Blind Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnoea Who Are Intolerant, Non-Compliant, or Naïve to Positive Airway Pressure

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Incannex Healthcare Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway pressure. Phase II study will be a 4-week dose-finding study comparing two dose strengths of IHL-42X to placebo. The optimal dose strength will be selected based on comparing the safety and efficacy of the two IHL-42X dose strengths to placebo over a 4-week treatment period. The three treatment groups are; IHL-42X Low dose (2.5mg dronabinol, 125mg acetazolamide), IHL-42X High dose (5mg dronabinol, 250mg acetazolamide) and Placebo. Each treatment group will enrol approximately 40 patients per treatment arm, for a total of approximately 120 patients. The safety and efficacy results of the Phase II study will be used to select the dose strength of IHL-42X and corresponding doses of dronabinol and acetazolamide in Phase III. Phase III study will use the optimal dose strength of IHL-42X identified in Phase II and will be compared to the component active pharmaceutical ingredients at equivalent dose strengths to those found in the IHL-42X optimal dose strength and placebo over 52 weeks. The four treatment groups are; IHL-42X (optimal dose from Phase II), Acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength), Dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) and placebo. The treatment groups will enrol approximately 165 patients in IHL-42X, approximately 55 patients in dronabinol, approximately 55 in acetazolamide, and approximately 165 in placebo, for a total of approximately 440 patients.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	IHL-42X Low Dose	Softgel capsule
DRUG	IHL-42X High Dose	Softgel capsule
DRUG	Placebo	Softgel capsule
DRUG	IHL-42X (Optimal Dose)	Softgel capsule
DRUG	Dronabinol	Softgel capsule
DRUG	Acetazolamide	Softgel capsule
DRUG	Placebo	Softgel capsule

Timeline

• Start date: 2024-05-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-11-24
• Last updated: 2025-04-20

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study