moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Kyntheum
Product Name: Kyntheum®
Product Code: N/A
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN o
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women =18 years of age at the time of screening - Subjects with chronic plaque type psoriasis diagnosed for at least 6 months before randomisation - Subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by PASI >10, affected BSA >10% and DLQI >10 - Subject has no known history of active tuberculosis - Subject has a negative test for tuberculosis taken at screening (negative QuantiFERON test) - Subject and/or subject’s designee is/are capable of administering subcutaneous injections 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 204 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy. • Previous or current PUVA (psoralens and ultraviolet A) therapy. • Washouts and non-permitted drugs: a) Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline b) Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids). c) Have received any biologic immune modulating treatment used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lifes of the received treatment, whichever is longer d) Have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used for indication other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lifes of the received treatment, whichever is longer. • Subjects with any of the following laboratory abnormalities at screening: a) Leukocyte cell count below 3×109/L or lymphocyte count below 0.7×109/L. b) Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit). c) Absolute neutrophil count ULN. • History of depressive disorder within the last 2 years including current anti-depressive treatment. • Any positive finding in history of suicidal behaviour (e.g., ‘actual suicide attempts’, ‘interrupted attempts’, ‘aborted attempts’, or ‘preparatory actions’) based on the eC-SSRS questionnaire at screening or baseline. • Any positive finding in suicidal ideation of level 4 or 5 (‘some intent to act, no plan’ or ‘specific plan and intent’) based on the eC-SSRS questionnaire at screening or baseline. • A PHQ-8 score of =10 corresponding to moderate to severe depression at screening or baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of subcutaneous injections of brodalumab to oral administration of fumaric acid esters in subjects with moderate to severe plaque psoriasis who are naive to systemic treatment. ; Primary end point(s): - At least 75% improvement from baseline at Week 24 in Psoriasis Area and Severity Index (PASI) - Static Physician’s Global Assessment (sPGA) scale score of 0 or 1 ;Timepoint(s) of evaluation of this end point: week 24; Secondary Objective: - To compare the effect on patient reported outcomes of subcutaneous injections of brodalumab to oral administration of fumaric acid esters in subjects with moderate to severe plaque psoriasis. - To evaluate the safety and tolerability of subcutaneous injections of brodalumab versus oral administration of fumaric acid esters in subjects with moderate to severe plaque psoriasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - At least 90% improvement from baseline at Week 24 in PASI - 100% improvement from baseline at Week 24 in PASI - Change from baseline at Week 24 in PASI score - PASI improvement (%) from baseline at Week 24 - Change from baseline at Week 24 in affected body surface area (BSA) - Burden of symptoms assessed as the normalised area under the curve (AUC) of PSI from baseline to the last available assessment ;Timepoint(s) of evaluation of this end point: week 24 | — |
Countries
Germany
Contacts
Public ContactGlobal Clinical Operations
LEO Pharma A/S
Outcome results
None listed