None listed
Conditions
Brief summary
This research project is being conducted to look at how safe, well tolerated and effective a new drug called DUR-928 is when given as an interlesional injection to participants with plaque-type psoriasis. The study will look at comparing the study drug’s safety, tolerability and effectiveness as a treatment for psoriasis using 2 different formulations when compared against placebo vehicle formulations, an active comparator and no treatment at all.
Interventions
DUR-928 solution: 30 mg/mL DUR-928 solution after constitution with sterile vehicle solution.
Placebo for solution: The sterile vehicle solution contains hydroxypropyl betadex in phosphate buffered water.
DUR-928 suspension: 25 mg/mL DUR-928 suspension after constitution with sterile vehicle suspension.
Placebo for suspension: The sterile vehicle suspension contains polyethylene glycol in phosphate buffered water.
Active Comparator: 2mg/mL Kenalog-10 (Triamcinolone Acetonide) after dilution wi
DUR-928 solution: 30 mg/mL DUR-928 solution after constitution with sterile vehicle solution. Placebo for solution: The sterile vehicle solution contains hydroxypropyl betadex in phosphate buffered water. DUR-928 suspension: 25 mg/mL DUR-928 suspension after constitution with sterile vehicle suspension. Placebo for suspension: The sterile vehicle suspension contains polyethylene glycol in phosphate buffered water. Active Comparator: 2mg/mL Kenalog-10 (Triamcinolone Acetonide) after dilution with sterile sodium chloride. Treatment Control: one site will contain no intervention. Each participant will be treated with 2 different formulations of study drug, 2 placebo (vehicle) formulations, one active comparator and one untreated area (6 treatments in total). Each treatment will be administered to every participant as three 100 microlitre intralesional injections, with the exception of the untreated area. All 5 treatments will be administered consecutively. Each treatment area is approximately 4cm^2. The planned study treatments are: A = DUR-928 Solution, 30 mg/mL (3 x 100 microlitre = 9 mg) B = DUR-928 Suspension, 25 mg/mL (3 x 100 microlitre = 7.5 mg) C = Vehicle for Solution, (3 x 100 microlitre = 0.3 mL) D = Vehicle for Suspension, (3 x 100 microlitre = 0.3 mL) E = Kenalog-10 (diluted) 2mg/mL (3 x 100 microlitre = 0.6 mg) F = Untreated area Unblinded study staff will administer all doses. Adherence to the correct dosing procedure will be documented in source data and review by an unblinded monitor. This is a single dose trial.
Sponsors
INC Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Moderate to severe chronic plaque-type psoriasis; Duration of Psoriasis of at least 6 months; Nominated total target plaque(s) must have a total approximate area of at least 562 cm to allow application of the study treatments, and must exclude the face, scalp, shin, genitals, and groin area The total area available for treatment may be split over a maximum of two contralateral plaques of equivalent LPSI, both of which meet the eligibility requirements. Generally healthy as determined by medical history and physical exam; BMI less than 35 kg/m2; Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed; Female subjects must be of non-childbearing potential.
Exclusion criteria
Presence of non-plaque psoriasis (ie pustular, erythrodermic). Presence of other skin condition other than psoriasis, in particular eczema, skin infections or an inherited skin disorder (other than psoriasis) that would interfere with the ability to perform study assessments. Participation in an investigational drug study within 30 days prior to dosing. Treatment of target plaque body region with topical medications within 2 weeks prior to dosing and during the study period. Treatment with Vitimin A supplements within 2 weeks prior to dosing and during the study period. Treatment with any systemic immunosuppressant medication within 6 months prior to dosing and during the study period. Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test.
Outcome results
None listed