drugset / Trial / NCT05942911

Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis

NCT05942911

Phase 2 Terminated 20 enrolled Incannex Healthcare Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this randomised, double-blind, placebo-controlled Phase II clinical trial is to assess the safety and effect of of IHL-675A in rheumatoid arthritis patients on pain, and function according to RAPID-3. 128 volunteers will be enrolled and randomised to one of four treatments (32 subjects per treatment). Each treatment will be self-administered twice daily for 24 weeks. The four treatments are: * Treatment 1 - IHL-675A * Treatment 2 - CBD * Treatment 3 - HCQ * Treatment 4 - Placebo

Timeline

Start
2023-11-22
Primary completion
2024-10-28
Completion
2025-10-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cannabidiol Other / unclassified 150 mg
Comparator Hydroxychloroquine Small molecule 200 mg
Subject IHL-675A Unknown

Indications