Chronic Plaque Psoriasis MedDRA version: 19.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
UCB Biopharma SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has provided informed consent - Chronic plaque psoriasis for at least 6 months prior to Screening - PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator’s Global Assessment) score 3 or greater on a 5-point scale - Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy - Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis - Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease - Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol - Subject taking prohibited psoriatic medications - Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving BCG vaccination within 1 year prior to study drug administration - Subject has previously received treatment with any anti-IL-17 therapy or has been exposed to more than 1 biological response modifier (limited to anti-TNF or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline - Subject has any current sign or symptom that may indicate an active infection (except for common cold)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the dose response of Bimekizumab administered subcutaneously in subjects with moderate to severe chronic plaque psoriasis.;Secondary Objective: - evaluate the efficacy of individual dose regimens of Bimekizumab compared to placebo after 12 weeks of treatment - compare the efficacy of the Bimekizumab dosage regimen 2 treatment group versus the Bimekizumab dosage regimen 3 treatment group (where dosage regimen 3 is the same as dosage regimen 2 but with a loading dose at Baseline) - assess the safety, immunogenicity and tolerability of Bimekizumab - assess the exposure response relationship of Bimekizumab - asses the pharmacokinetics of Bimekizumab and characterize the population pharmacokinetics of Bimekizumab;Primary end point(s): Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 12 - Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 8 - Percentage of subjects achieving a 90% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 8 - Percentage of subjects achieving a 75% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 12 - Percentage of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 12;Timepoint(s) of evaluation of this end point: - Week 8 - Week 12 | — |
Countries
Canada, Czech Republic, Hungary, Japan, Poland, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed