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

NCT ID: NCT03331835

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2019-03-21

Brief 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.

Detailed Description

A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brodalumab

Kyntheum® (brodalumab)

pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections.

First 3 injections are administered weekly, and hereafter every two weeks (Q2W).

Group Type: EXPERIMENTAL

Brodalumab

Intervention Type: BIOLOGICAL

Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2-antibody that binds with high affinity to human interleukin 17 receptor A (IL-17RA).

Blocking IL-17RA inhibits IL-17 cytokine-induced responses and results in reduced or normalised inflammation of the skin in subjects with psoriasis.

Fumaric acid esters

Fumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)

Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)

Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label.

Group Type: ACTIVE_COMPARATOR

Fumaric acid esters

Intervention Type: DRUG

Fumaric acid esters have been used to treat psoriasis since 1959. Systemic therapy with fumaric acid esters is based on an established dosing scheme with a gradual increase to improve tolerability, especially with regards to gastrointestinal side effects.

Interventions

Brodalumab

Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2-antibody that binds with high affinity to human interleukin 17 receptor A (IL-17RA).

Blocking IL-17RA inhibits IL-17 cytokine-induced responses and results in reduced or normalised inflammation of the skin in subjects with psoriasis.

Intervention Type: BIOLOGICAL

Fumaric acid esters

Fumaric acid esters have been used to treat psoriasis since 1959. Systemic therapy with fumaric acid esters is based on an established dosing scheme with a gradual increase to improve tolerability, especially with regards to gastrointestinal side effects.

Intervention Type: DRUG

Other Intervention Names

Kyntheum®; Fumaderm®

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-003867-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0160-1327

Identifier Type: -

Identifier Source: org_study_id