NCT05942911 - Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 22, 2023

Primary Completion Date

October 28, 2024

Study Completion Date

October 28, 2025

Conditions

Rheumatoid Arthritis

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.

Trial Locations (10)

2019

Emeritus Research, Sydney

2050

Royal Prince Alfred Hospital, Camperdown

2289

Novatrials, Kotara

2292

Genesis Research Services, Broadmeadow

2606

Paratus Clinical (Woden Dermatology), Phillip

3124

Emeritus Research Melbourne, Camberwell

4068

AusTrials Westside (Taringa), Taringa

4121

AusTrials Wellers Hill, Wellers Hill

4558

Coast Joint Care, Maroochydore

6009

Captain Sterling Medical Centre, Nedlands