Dose-escalating study evaluating safety, PK & PD in psoriasis patients
Research type
Research Study
Full title
A RANDOMIZED, SUBJECT-BLIND, INVESTIGATOR-BLIND,PLACEBO-CONTROLLED, SINGLE-DOSE,DOSE-ESCALATING STUDY EVALUATING THE SAFETY,PHARMACOKINETICS, AND PHARMACODYNAMICS OF UCB0159 IN SUBJECTS WITH MILD TO MODERATE PSORIASIS\n
IRAS ID
228379
Contact name
Muna Albayaty
Contact email
Sponsor organisation
UCB CELLTECH
Eudract number
2017-000168-14
Duration of Study in the UK
0 years, 8 months, 23 days
Research summary
This is a first-in-human, randomised, subject-blind, investigator-blind, placebo-controlled, single-dose, dose-escalating study to evaluate safety, pharmacokinetics (PK) and pharmacodynamics (PD) of UCB0159 in subjects with mild to moderate psoriasis.\n\nThe main purpose of the study is to see how safe the drug is and how well the body tolerates the study drug after single increased doses, administered by intravenous (IV) infusion or subcutaneous (SC) injection to subjects with mild to moderate psoriasis. The PK evaluation will evaluate how the study drug is absorbed (taken up by the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body), by measuring the amount of study drug in blood samples. The PD evaluation will assess the effects of the study drug and the way in which the study drug works (mechanism of action), by evaluating skin lesions and measuring specific biomarkers in blood samples. The study also includes assessments of bioavailability (the proportion of study drug which enters the blood circulation when introduced into the body and thus able to have an active effect) and immunogenicity (formation of antibodies against the study drug), as well as investigation into the role of genetics on the effects of the study drug (pharmacogenomic and pharmacogenetic evaluations).\n\nThe trial will comprise a screening visit, a 4-day clinic stay and a follow-up period of 12 weeks. The expected maximum duration of participation for each subject will be approximately 16 weeks.\n\nEligible subjects will be allocated to one of five cohorts, with planned dose levels of UCB0159 8 mg, 40 mg, 160 mg, 480 mg and 640 mg. Sentinel dosing will be performed when a new dose level is tested. After a cohort has completed the available safety and PK data will be reviewed prior to increasing the dose for the next cohort. UCB0159 or placebo will be administered by IV infusion in all cohorts. In Cohort 3, half of the enrolled subjects will receive the study drug by SC injection.\n\nUCB0159 is being developed by UCB Biopharma SPRL, Belgium, for the management of psoriasis. It is foreseen for patients who are difficult to treat and who are refractory to current biologic products to benefit from complete inhibition of the cytokines IL-17A and IL-17F and TNFα offered by UCB0159.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
17/WM/0210
Date of REC Opinion
21 Jun 2017
REC opinion
Further Information Favourable Opinion