Incannex Healthcare has commenced a Phase II clinical trial of its anti-inflammatory combination drug IHL-675A in patients with rheumatoid arthritis (RA).
The blinded, placebo-controlled trial will evaluate the efficacy, safety, and tolerability of IHL-675A, a fixed-dose combination drug that consists of cannabidiol (CBD) and hydroxychloroquine (HCQ), for use in the treatment of pain and function in RA.
It follows the successful Phase I trial where the drug was observed to be well tolerated, with no adverse events of concern.
The Phase II trial will assess IHL-675A against the respective component Active Pharmaceutical Ingredients (APIs), CBD and HCQ, and a placebo.
It will include 120 subjects who meet the eligibility criteria. They will be randomised to one of four arms: either IHL-675A, CBD alone, HCQ alone, or a placebo.
Pain and function relative to baseline, determined through the score on the RAPID3 assessment at 24 weeks, is the trial’s primary endpoint.
Avance Clinical will manage the trial and engage eight to ten clinical trial sites across Australia and New Zealand to conduct patient recruitment and assessments.
Participants of the trial will attend monthly visits at the site, where physical examinations and blood tests will monitor additional safety and efficacy outcomes including inflammatory biomarkers.
Additionally, the trial will include a sub-study examining joint damage through magnetic resonance imaging (MRI).
Based on the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) of the participants at screening, they will be assessed for eligibility in the MRI study.
After completing the randomisation period of 24 weeks, trial participants will have the option to roll over into the open label extension study, where they will receive IHL-675A for another 24 weeks.
Incannex chief scientific officer Dr Mark Bleackley said: “Arthritis is a disease that negatively impacts the well-being of millions of people worldwide and this trial is a big step toward Incannex potentially improving the quality of life for these patients.
“We look forward to continuing to build our research relationship with Avance Clinical, who did an outstanding job managing the Phase I clinical trial assessing the tolerability and pharmacokinetics of IHL-675A in healthy volunteers.”