A Phase II, Blinded, Randomised, Placebo Controlled Clinical Trial to Determine the Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis

Official 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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 20 participants

Interventions

• DRUG: IHL-675A — Combination product containing CBD and HCQ UniGel™ technology by ProCaps®. IHL-675A consists of a solid, film coated HCQ tablet that is contained within a CBD oil solution gel cap. Each IHL-675A gel cap contains 75 mg of CBD and 100 mg HCQ.
• DRUG: Cannabidiol — Formulated using UniGel™ technology by ProCaps®. The CBD soft gel capsules contain 75 mg CBD oil solution. These capsules look identical to the IHL-675A UniGel™ capsules, to aid double-blinding
• DRUG: Hydroxychloroquine — Formulated using UniGel™ technology by ProCaps®. The soft gel capsules each contain a 100 mg HCQ tablet. These capsules look identical to the IHL-675A UniGel™ capsules to aid double-blinding.
• DRUG: Placebo — Formulated using UniGel™ technology by ProCaps®. The soft gel capsules contain the inactive ingredients of the IHL-675A capsules and no active ingredients. These capsules look identical to the IHL-675A UniGel™ capsules to aid double-blinding.

Primary Outcomes

• Change in pain and function (24 weeks)

Secondary Outcomes

• Safety and tolerability - Incidence of the use of concomitant medications for pain management (4, 8, 12, 16, 20 and 24 weeks)
• Safety and tolerability - Vital signs - Temperature (4, 8, 12, 16, 20 and 24 weeks)
• Safety and tolerability - Vital signs - Pulse Rate (4, 8, 12, 16, 20 and 24 weeks)
• Safety and tolerability - Vital signs - Respiratory Rate (4, 8, 12, 16, 20 and 24 weeks)
• Safety and tolerability - Vital signs - Blood Pressure (4, 8, 12, 16, 20 and 24 weeks)

Trial Locations

• Paratus Clinical (Woden Dermatology), Phillip, Australian Capital Territory, Australia
• Genesis Research Services, Broadmeadow, New South Wales, Australia
• Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
• Novatrials, Kotara, New South Wales, Australia
• Emeritus Research, Sydney, New South Wales, Australia
• Coast Joint Care, Maroochydore, Queensland, Australia
• AusTrials Westside (Taringa), Taringa, Queensland, Australia
• AusTrials Wellers Hill, Wellers Hill, Queensland, Australia
• Emeritus Research Melbourne, Camberwell, Victoria, Australia
• Captain Sterling Medical Centre, Nedlands, Western Australia, Australia

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