A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2019-03-21
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis. > Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.>

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Antibodies, Monoclonal; Brodalumab; Dimethyl Fumarate

Criteria

Main Criteria for Inclusion:>

• Men or women ≥18 years of age at the time of screening.>

• Subjects with chronic plaque type psoriasis diagnosed 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.>

Main Criteria for Exclusion:>

• 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:>

1. Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or>

2. Have had topical psoriasis treatment within 2 weeks of baseline (exceptions:

bland emollients without urea or beta or alpha hydroxy acids)>

3. Have received any biologic immune modulating treatments used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer>

4. 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 indications other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer.>

• Subjects with any of the following laboratory abnormalities at screening:>

1. Leukocyte cell count below 3×10^9/L or lymphocyte count below 0.7×10^9/L>

2. Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit)>

3. Absolute neutrophil count < 2×10^9/L>

4. Serum creatinine > ULN.>

• History of depressive disorder within the last 2 years including current antidepressive treatment.>

• Subjects with a history of suicidal behaviour (suicide attempt). >

• Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.>

• A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.>