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COMPLETED

NCT04306315

PHASE4

Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

Sponsor: LEO Pharma

View on ClinicalTrials.gov

Summary

This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.

Official title: Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

385

Start Date

2022-07-21

Completion Date

2026-01-05

Last Updated

2026-04-24

Healthy Volunteers

Conditions

Psoriasis Vulgaris

Interventions

BIOLOGICAL

Brodalumab

Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.

Key Inclusion Criteria: * Signed and dated informed consent has been obtained prior to any protocol-related procedures. * Age ≥18 to \<75 years at the time of screening. * Diagnosed with chronic plaque psoriasis at least 6 months before randomisation. * Body weight ≥120 kg at the time of screening. * Moderate-to-severe plaque psoriasis as defined by: BSA ≥10% and PASI ≥12 at screening and baseline. * No evidence of active or latent tuberculosis according to local standard of care. Key Exclusion Criteria: * Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema) that would interfere with evaluations of the effect of the investigational medicinal product (IMP) on participants with plaque psoriasis. * Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations, or is immunocompromised (e.g., human immunodeficiency virus, hepatitis B, and hepatitis C). * Any systemic disease considered by the investigator to be uncontrolled and either immunocompromising the participants and/or placing the participant at undue risk of intercurrent diseases (including, but not limited to, renal failure, heart failure, liver disease, diabetes, and anaemia). * History of Crohn's disease. * Myocardial infarction or stroke, or unstable angina pectoris within the past 12 months. * Any active malignancy. * History of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma. * History of suicidal behaviour (i.e., 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or at baseline. * Any suicidal ideation of category 4 or 5 ('active suicidal ideation with some intent to act, without specific plan' or ' active suicidal ideation with specific plan and intent') based on the C-SSRS questionnaire at screening or at baseline. * A Patient Health Questionnaire (PHQ)-8 score of ≥10 corresponding to moderate-to-severe depression at screening or at baseline.