Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumato… (NCT05942911) | Clinical Trial Compass
TerminatedPhase 2
Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis
Stopped: Recruitment challenges
Australia20 participantsStarted 2023-11-22
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must have given written informed consent, before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects
✓. Has been diagnosed with RA and on stable treatment for RA for at least 3 months prior to the screening visit
✓. Subject has a RAPID-3 score of \>4.5 at screening
✓. Male or female, aged 18 or older inclusive at the screening visit
✓. Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
✓. Has at least two swollen or tender joints on the JC 66/68 at screening
✓. Subject is otherwise medically healthy (in the opinion of the investigator), as determined by pre-study medical history and without clinically significant abnormalities including:
✓. Physical examination at screening without any additional clinically relevant findings apart from those consistent with RA in the opinion of the investigator.
✕. Known hypersensitivity to any of the study drug ingredients (cannabis products, sesame oil, hydroxychloroquine or chloroquine)
✕. History of any clinically significant (in the opinion of the investigator) disorder within the last 3 months including cardiovascular (cardiac disease or arrythmias), haematologic, pulmonary, hepatic, renal, or gastrointestinal (such as cholecystitis, Gilbert's syndrome) disorders, or connective tissue, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic, or any disorder within the last 3 months that may prevent the successful completion of the study or influence the absorption, distribution, metabolism, excretion or action of the study drug (in the opinion of the investigator). Note: a history of fully resolved childhood asthma is not exclusionary; a history of cholecystectomy is not exclusionary
✕. Family history of QT issues
✕. Currently taking or have taken hydroxychloroquine, chloroquine or any drugs containing HCQ or chloroquine within 3 months of screening
✕. Taking more than 10 mg prednisone per day
✕. Pregnant, lactating, planning to become pregnant
✕. Known substance abuse or medical, psychological, or social conditions or significant psychiatric illness (defined as hospitalisation), suicidal ideation, or suicidal attempts that, in the opinion of the investigator, may interfere with the subjects inclusion in the clinical study or evaluation of the clinical study results
✕. Regular consumption of \>10 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer \[4.9% Alc/Vol\], 100 mL wine \[12% Alc/Vol\], 30 mL spirit \[40% Alc/Vol\])