Incannex Healthcare has received the Bellberry Human Research Ethics Committee (HREC) approval to conduct its Phase II clinical trial of the IHL-675A drug for the treatment of rheumatoid arthritis (RA) at the lead site, Emeritus Research in Camberwell, Victoria, Australia.

The pivotal, double-blinded study will compare the safety, tolerability, and efficacy of the proprietary anti-inflammatory combination product IHL-675A against the respective component active pharmaceutical ingredients (APIs), cannabidiol (CBD) and hydroxychloroquine sulphate (HCQ), and placebo.

It intends to enrol a total of 128 participants from eight to ten sites across Australia and New Zealand. Australian and US CRO Avance Clinical will manage the trial.

Patients who have ongoing pain, reduced function and are stable at treatment for their RA will be included in the study.

They will be randomised into four arms to receive either IHL-675A, CBD, HCQ or placebo.

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Using an electronic patient-reported outcomes device, patients are advised to record their pain and function outcomes and complete the questionnaire on fatigue, pain, joint stiffness and quality of life every day.

They will also provide their blood test samples during monthly visits at the clinical trial site and undergo physical examinations for monitoring additional efficacy and safety outcomes, including inflammatory biomarkers.

Pain and function relative to baseline, as determined through the RAPID3 assessment score at 24 weeks, is the primary endpoint of the study.

The trial results will be used further to file regulatory applications, including contributing to the combination rule assessment in the FDA505(b) new drug application (NDA) dossier.

Incannex chief scientific officer Dr Mark Bleackley said: “We look forward to working with Emeritus and Avance to assess the effect of IHL675A in this patient population.”