Moderate to Severe Chronic Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female at least 18 years of age - Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit - Subject must have Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5 point scale - Subject must be a candidate for systemic PSO therapy and/or phototherapy - Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label - Female subject of child bearing potential must be willing to use highly effective method of contraception 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 640 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection - Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study - Presence of active suicidal ideation or severe depression - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Evaluate the efficacy of bimekizumab compared to secukinumab at pre-defined time-points - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs leading to withdrawal adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) ;Primary end point(s): Psoriasis Area and Severity Index 100 (PASI100) response at Week 16 ;Timepoint(s) of evaluation of this end point: Week 16 ;Main Objective: Compare the efficacy of bimekizumab versus secukinumab at achieving complete clearance (PASI100) in subjects with moderate to severe chronic plaque psoriasis (PSO). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PASI75 response at Week 4 2. PASI90 response at Week 16 3. PASI100 response at Week 48 4. Investigator´s Global Assessment (IGA) response (0/1) at Week 16 5. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) 6. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP 7. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP ;Timepoint(s) of evaluation of this end point: 1: Week 4 2,4: Week 16 3: Week 48 5, 6, 7: From Baseline to Safety Follow Up (up to Week 160) | — |
Countries
Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed