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 SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must be at least 18 years of age - Chronic plaque PSO for at least 6 months prior to the Screening Visit - 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 is a candidate for systemic PSO therapy and/or phototherapy - 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 390 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 a known hypersensitivity to any excipients of bimekizumab or adalimumab - Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent 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 - Subject has had previous exposure to adalimumab - Presence of active suicidal ideation or positive suicide behavior - Presence of moderately severe major depression or severe major 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 |
|---|---|
| Main Objective: Compare the efficacy of bimekizumab administered for 16 weeks versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO). ;Secondary Objective: - Evaluate the efficacy of bimekizumab compared to adalimumab after 4, 16, and 24 weeks of treatment - Evaluate the efficacy of bimekizumab compared to adalimumab at achieving complete clearance (PASI100) after 16 weeks and 24 weeks of treatment - Assess the maintenance of efficacy of bimekizumab dosing 1 versus dosing 2 at Week 56 - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment ;Primary end point(s): 1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 2. Investigator’s Global Assessment (IGA) response at Week 16 ;Timepoint(s) of evaluation of this end point: 1-2: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PASI90 response at Week 24 2. IGA response at Week 24 3. PASI75 response at Week 4 4. PASI100 response at Week 16 5. PASI100 response at Week 24 6. PASI90 response at Week 56 7. IGA response at Week 56 8. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment 9. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment 10. Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment ;Timepoint(s) of evaluation of this end point: 1,2,5: Week 24 3: Week 4 4: Week 16 6-7: Week 56 8-10: From Baseline to Safety Follow Up (up to Week 76) | — |
Countries
Australia, Canada, Czech Republic, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed