None listed
Conditions
Brief summary
The primary objective is to evaluate the safety and tolerability of subcutaneous injections of ART621 given every 2 weeks for 6 doses as assessed by adverse events and clinical laboratory data. Assessments of efficacy will include the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), photographs and the Dermatology Life Quality Index (DLQI). Each subject will be on-study for 18-20 weeks, consisting of a 2-4 week screening period, followed by a 12 week treatment period and then a 4 week follow up. Each subject will receive their designated dose of ART621 on 6 occasions over the 12 week treatment period and will be monitored closely throughout.
Interventions
ART621 - subcutaneous administration of 0.5, 1.0 or 2.0mg/kg every 2 weeks for 6 injections
Sponsors
Arana Therapeutics Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Active but clinically stable, plaque psoriasis of at least 12 months duration Psoriasis involving > 5% of the body surface area Psoriasis of at least moderate severity. Subjects must have either a) active psoriasis despite topical therapies or b) a Physician Global Assessment rating of at least “moderate”
Exclusion criteria
Females who are either lactating or pregnant Males and females of child bearing potential who do not agree to use, as a minimum, one medically acceptable method of contraception throughout the study period until the final study visit. Acceptable methods that may be used are abstinence, birth control pills or patch, diaphragm with spermicide, intra uterine device (coil), condom and foam, surgical sterilization or progestin implant or injection, and vasectomized partners. Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit. Evidence of skin conditions, or severe extremely psoriasis, or significant flair of psoriasis, at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of Investigational Product on psoriasis. ALT and AST > 1.5 x upper limit of normal (ULN), haemoglobin < 10 g/dL. Clinically significant condition, infection or laboratory toxicity, at the time of the screening visit or between the screening visit and the administration of the Investigational Product that in the opinion of the Investigator would preclude participation in the study. Evidence of clinically significant infection within 30 days of the screening visit that in the opinion of the Investigator would preclude participation in the study including hepatitis and tuberculosis. Subjects will be screened for HIV, Hepatitis B & C and tuberculosis. Any other known infections that would in the Investigator’s discretion, interfere with the subject’s ability to participate in the study. History or any evidence of squamous cell carcinoma or melanoma and/or current cutaneous basal cell carcinoma. History or evidence of other malignancy. Current or history of psychiatric disease that would interfere with the ability to comply with the study protocol or give informed consent. History or evidence of alcohol or drug abuse that would interfere with the ability to comply with the study protocol. Inability to restrict alcohol consumption to 2 standard drinks per day for males and 1 standard drink per day for females, for the duration of the study. Prior use of any anti-TNF agent or other investigational biologic agent for psoriasis (including but not limited to etanercept, adalimumab, infliximab alefacept and efalizumab). Receipt of any Investigational Product(s) within 28 days of the first dose of Investigational Product in this study. Phototherapy (Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and UVA (PUVA)) within 14 days of the first dose of Investigational Product. Receipt of any systemic psoriasis therapy within 28 days of the first dose of Investigational Product (including but not limited to oral or parenteral steroids, cyclosporine, methotrexate, other disease-modifying anti-rheumatic drugs (DMARDs), retinoids (e.g. acitretin) calcineurin inhibitors etc). Topical medication within 14 days of the first dose of Investigational Product other than medicated shampoos and low potency steroids. (Excluded medications include, but are not limited to, high potency steroids, topical vitamin A or D analog preparations, anthralin or topical cyclosporine or calcineurin inhibitors). Intravenous or oral calcineurin inhibitors such as tacrolimus (Prograf) within 28 days of the first dose of Investigational Product. Administration of live vaccines within 14 days of the first dose of Investigational Product. Body weight >132 kg. Subjects with a history of liver disease including fatty liver.
Outcome results
None listed