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

NCT ID: NCT04305327

Last Updated: 2025-03-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-07

Study Completion Date

2023-05-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind until Week 12, where the primary endpoint is assessed. Open-label active comparator treatment from Week 0 to Week 52, but with blinded outcomes assessor throughout the study.

Study Groups

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Brodalumab

Brodalumab for 52 weeks. The dose will be determined by the participant's body weight.

Group Type EXPERIMENTAL

Brodalumab

Intervention Type DRUG

Solution for subcutaneous injection.

Ustekinumab

Ustekinumab for 52 weeks. The dose will be determined by the participant's body weight.

Group Type ACTIVE_COMPARATOR

Ustekinumab

Intervention Type DRUG

Solution for subcutaneous injection.

Placebo/brodalumab

Placebo for the first 12 weeks and brodalumab for the following 40 weeks. The dose will be determined by the participant's body weight.

Group Type PLACEBO_COMPARATOR

Brodalumab

Intervention Type DRUG

Solution for subcutaneous injection.

Placebo

Intervention Type DRUG

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

Placebo/ustekinumab

Placebo for the first 12 weeks and ustekinumab for the following 40 weeks. The dose will be determined by the participant's body weight.

Group Type PLACEBO_COMPARATOR

Ustekinumab

Intervention Type DRUG

Solution for subcutaneous injection.

Placebo

Intervention Type DRUG

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

Interventions

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Brodalumab

Solution for subcutaneous injection.

Intervention Type DRUG

Ustekinumab

Solution for subcutaneous injection.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Kyntheum® Stelara®

Eligibility Criteria

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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.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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LEO Pharma Investigational Site

Brussels, , Belgium

Site Status

LEO Pharma Investigational Site

Liège, , Belgium

Site Status

LEO Pharma Investigational Site

Toulouse, , France

Site Status

LEO Pharma Investigational Site

Bad Bentheim, , Germany

Site Status

LEO Pharma Investigational Site

Essen, , Germany

Site Status

LEO Pharma Investigational Site

Frankfurt, , Germany

Site Status

LEO Pharma Investigational Site

Hamburg, , Germany

Site Status

LEO Pharma Investigational Site

Hamburg, , Germany

Site Status

LEO Pharma Investigational Site

Langenau, , Germany

Site Status

LEO Pharma Investigational Site

Lübeck, , Germany

Site Status

LEO Pharm Investigational Site

Mainz, , Germany

Site Status

LEO Pharma Investigational Site

Münster, , Germany

Site Status

LEO Pharma Investigational Site

Athens, , Greece

Site Status

LEO Pharma Investigational Site

Piraeus, , Greece

Site Status

LEO Pharma Investigational Site

Thessaloniki, , Greece

Site Status

LEO Pharma Investigational Site

Debrecen, , Hungary

Site Status

LEO Pharma Investigational Site

Orosháza, , Hungary

Site Status

LEO Pharma Investigational Site

Brescia, , Italy

Site Status

LEO Pharma Investigational Site

Napoli, , Italy

Site Status

LEO Pharma Investigational Site

Padua, , Italy

Site Status

LEO Pharma Investigational Site

Iwonicz-Zdrój, , Poland

Site Status

LEO Pharma Investigational Site

Lodz, , Poland

Site Status

LEO Pharma Investigational Site

Poznan, , Poland

Site Status

LEO Pharma Investigational Site

Skierniewice, , Poland

Site Status

LEO Pharma Investigational Site

Warsaw, , Poland

Site Status

LEO Pharma Investigational Site

Warsaw, , Poland

Site Status

LEO Pharma Investigational Site

Wroclaw, , Poland

Site Status

LEO Pharma Investigational Site

Wroclaw, , Poland

Site Status

LEO Pharma Investigational Site

Wroclaw, , Poland

Site Status

LEO Pharma Investigational Site

Alicante, , Spain

Site Status

LEO Pharma Investigational Site

Barcelona, , Spain

Site Status

LEO Pharma Investigational Site

Granada, , Spain

Site Status

LEO Pharma Investigational Site

Madrid, , Spain

Site Status

LEO Pharma Investigational Site

Pontevedra, , Spain

Site Status

LEO Pharma Investigational Site

Valencia, , Spain

Site Status

Countries

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Belgium France Germany Greece Hungary Italy Poland Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-001868-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1282-4459

Identifier Type: OTHER

Identifier Source: secondary_id

LP0160-1396

Identifier Type: -

Identifier Source: org_study_id

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