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completed
Phase 4

NCT03331835

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

Sponsored by LEO Pharma

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.

Eligibility 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.

Locations (30)

Fachklinik Bad Bentheim Klinik für Dermatologie

Bad Bentheim, Germany

Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum

Berlin, Germany

Rothhaar Studien GmbH Dermatologisches Studienzentrum

Berlin, Germany

Hautarztpraxis Dr. Wildfeuer

Berlin, Germany

Klinikum Bielefeld Klinik für Dermatologie und Allergologie

Bielefeld, Germany

Hauttumorzentrum Ruhr- Universität im St. Josef Hospital

Bochum, Germany

Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus

Bochum, Germany

Universitätsklinikum Bonn (AöR) Klinik und Poliklinik für Dermatologie und Allergologie

Bonn, Germany

Elbe Klinikum Buxtehude Klinik für Dermatologie

Buxtehude, Germany

Rosenpark Research

Darmstadt, Germany

Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie

Dresden, Germany

Universitätsklinikum Erlangen Hautklinik

Erlangen, Germany

Universitätsklinikum Frankfurt Klinik für Dermatologie

Frankfurt, Germany

Derma-Study-Center-Friedrichshafen

Friedrichshafen, Germany

Gemeinschaftspraxis Rotterdam & Kollegen Facharzt für Haut & Geschlechtskrankheiten

Gelsenkirchen, Germany

Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen

Hamburg, Germany

SCIderm GmbH

Hamburg, Germany

Medizinische Hochschule Hannover Klinik für Dermatologie Allergologie und Venerologie

Hanover, Germany

Universitäts-Hautklinik Heidelberg

Heidelberg, Germany

Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel Psoriasis-Zentrum

Kiel, Germany

Exellenzzentrum Entzündungsmedizin (CCIM) Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

University Medical Center Mainz Department of Dermatology and Allergy, Clinical Research Center

Mainz, Germany

Universitätsklinikum Mannheim der Universität Heidelberg Klinik für Dermatologie, Venerologie und Allergologie

Mannheim, Germany

Technische Universität München Klinik und Poliklinik für Dermatologie und Allergologie

München, Germany

Klinische Forschung Osnabrück - Klifos

Osnabrück, Germany

KLINIKUM VEST GmbH Knappschaftskrankenhaus Recklinghausen Klinik für Dermatologie und Allergologie

Recklinghausen, Germany

Gemeinschaftspraxis Weber & Crainic

Schweinfurt, Germany

Hautarztpraxis Dres. Leitz

Stuttgart, Germany

University Medical Center University of Tübingen

Tübingen, Germany

Hautarztpraxis

Witten, Germany

Why you can trust this information
Registry sourcesclinicaltrials_gov
Source last updated3/13/2025
Clintriva indexed9/27/2026, 9:21:09 PM
Registry records1
Relationships needing review0

Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.

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Quick Facts
Start DateNov 3, 2017
CompletionJan 24, 2019
Enrollment0/210
CountryGermany

Conditions

Psoriasis Vulgaris
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