Status:
COMPLETED
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
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 previo...
Detailed Description
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
Eligibility Criteria
Inclusion
- 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:
- Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or
- Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids)
- 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
- 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:
- Leukocyte cell count below 3×10\^9/L or lymphocyte count below 0.7×10\^9/L
- Aspartate aminotransferase (AST) or alanine transferase (ALT) \> 2× ULN (upper level of normal limit)
- Absolute neutrophil count \< 2×10\^9/L
- 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.
Exclusion
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2019
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03331835
Start Date
November 3 2017
End Date
March 21 2019
Last Update
March 13 2025
Active Locations (30)
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1
Fachklinik Bad Bentheim Klinik für Dermatologie
Bad Bentheim, Germany, 48455
2
Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum
Berlin, Germany, 10117
3
Rothhaar Studien GmbH Dermatologisches Studienzentrum
Berlin, Germany, 10783
4
Hautarztpraxis Dr. Wildfeuer
Berlin, Germany, 13055