Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

Phase 3TerminatedNCT04305327

LEO Pharma12 enrolled

Overview

The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses. The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis

Interventions

BrodalumabDRUG

Solution for subcutaneous injection.

UstekinumabDRUG

Solution for subcutaneous injection.

PlaceboDRUG

The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Subject was diagnosed with chronic plaque psoriasis at least 6 months before randomisation. * Subject has a diagnosis of moderate-to-severe plaque psoriasis as defined by PASI ≥12, sPGA ≥3, and body surface area ≥10% at screening and at baseline. * Subject, in whom topical therapy is not adequate, and who is a candidate for systemic therapy. * Subject has no evidence of active or latent tuberculosis according to local standard of care. Key Exclusion Criteria: * Subject is diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema). * Subject has been vaccinated with a tetanus toxoid-containing vaccine ≤18 months prior to first dose of investigational medicinal product (IMP). For EU and UK: Subject has been vaccinated with a TT-containing vaccine within 5 years prior to the first dose of IMP. * Subject has developed or experienced either Guillian-Barre syndrome, encephalopathy, Arthus-type hypersensitivity, or severe allergic reactions in connection with previous Tdap or Td vaccine. * Subject with chronic or recurrent infections, or active infection, systemically treated within 4 weeks prior to first dose of IMP. * Subject has a known history of Crohn's disease. * Subject has any active malignancy or a history of any malignancy within 5 years. * Subject has a history of suicidal behaviour and has suicidal ideation with some intent to act or specific plan and intent. * Subject has a history of depressive disorder with severe episode(s) within the last 2 years. * Subject has received anti-IL-12/23p40 for less than 12 months prior to the first dose of IMP or has previously no response to anti-IL-12/23p40 therapy. * Subject has previously received anti-IL-17 therapy.

Locations (35)

Outcomes

Primary Outcomes

Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12.

PASI 75 response is defined as having at least 75% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, were assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions was also assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Time frame: Baseline to Week 12

Secondary Outcomes

Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12.

The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed.

Time frame: Week 12

sPGA Score of 0, Assessed at Week 12.

Time frame: Week 12

PASI 90 Response, Assessed at Week 12.

PASI 90 response is defined as having at least 90% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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