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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03331835
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	LEO Pharma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Study Director
Principal Investigator Affiliation	LEO Pharma
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriasis Vulgaris

Additional Details

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

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International Sites

Bad Bentheim, Germany

Status

Recruiting

Address

Fachklinik Bad Bentheim Klinik für Dermatologie

Bad Bentheim, , 48455

Site Contact

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