A phase 4 trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate to severe plaque psoriasis

Phase 1

• Conditions: moderate to severe plaque psoriasis; MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-003867-21-DE
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 204

Inclusion Criteria

- Men or women =18 years of age at the time of screening
- Subjects with chronic plaque type psoriasis diagnosed for 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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:
a) Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline
b) Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids).
c) Have received any biologic immune modulating treatment used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lifes of the received treatment,
whichever is longer
d) 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 indication other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lifes of the received treatment, whichever is longer.
• Subjects with any of the following laboratory abnormalities at screening:
a) Leukocyte cell count below 3×109/L or lymphocyte count below 0.7×109/L.
b) Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit).
c) Absolute neutrophil count < 2× 109/L.
d) Serum creatinine > ULN.
• History of depressive disorder within the last 2 years including current anti-depressive treatment.
• Any positive finding in history of suicidal behaviour (e.g., ‘actual suicide attempts’, ‘interrupted attempts’, ‘aborted attempts’, or ‘preparatory actions’) based on the eC-SSRS questionnaire at screening or baseline.
• Any positive finding in suicidal ideation of level 4 or 5 (‘some intent to act, no plan’ or ‘specific plan and intent’) based on the eC-SSRS questionnaire at screening or baseline.
• A PHQ-8 score of =10 corresponding to moderate to severe depression at screening or baseline.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified