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

NCT ID: NCT04306315

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2026-01-05

Brief Summary

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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.

Detailed Description

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Brodalumab is an anti-IL-17 receptor antibody and blocks the inflammatory effects of IL-17 in the skin. Some psoriasis patients with a higher body weight experienced a lower treatment effect of brodalumab in clinical studies. Therefore, the purpose of this study is to investigate if increasing the dose of brodalumab will increase the effect of treatment for patients with a higher body weight. The study will run over 60-62 weeks, including screening, treatment period and safety follow-up, with the primary endpoint measurement at Week 40. Patients will receive subcutaneous injections of brodalumab at Week 0, 1, and 2, followed by injections every 2 weeks. Participants not fulfilling a predefined response at any time after Week 16 will receive a dose adjustment to 280 mg brodalumab or 210 mg brodalumab plus placebo every 2 weeks.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The pre-filled syringes with 210 mg (1.5 mL) brodalumab will be open-label. The packaging and labelling of the pre-filled syringes with 70 mg (0.5 mL) brodalumab or placebo will contain no evidence to distinguish brodalumab from placebo. It is not considered possible to distinguish between brodalumab and placebo visually; both solutions are colourless.

Study Groups

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Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen)

Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. \*Participants not fulfilling a predefined response at any visit with efficacy assessments after Week 16 will receive a dose adjustment to 280 mg brodalumab every 2 weeks.

Group Type EXPERIMENTAL

Brodalumab

Intervention Type BIOLOGICAL

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

Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment)

Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. \*Participants not fulfilling a predefined response at any time visit with efficacy assessments Week 16 will receive a dose adjustment to 210 mg brodalumab + placebo every 2 weeks.

Group Type PLACEBO_COMPARATOR

Brodalumab

Intervention Type BIOLOGICAL

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

Interventions

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Brodalumab

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 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 Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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LEO Pharma Investigational Site

Brussels, , Belgium

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LEO Pharma Investigational Site

Ham-sur-Heure-Nalinnes, , Belgium

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LEO Pharma Investigational Site

Leuven, , Belgium

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LEO Pharma Investigational Site

Liège, , Belgium

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LEO Pharma Investigational Site

Kutná Hora, , Czechia

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LEO Pharma Investigational Site

Nový Jičín, , Czechia

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LEO Pharma Investigational Site

Plzen-Bory, , Czechia

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LEO Pharma Investigational Site

Amiens, Somme, France

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LEO Pharma Investigational Site

Saint-Priest-en-Jarez, , France

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LEO Pharma Investigational Site

Toulouse, , France

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LEO Pharma Investigational Site

Valence, , France

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LEO Pharma Investigational Site

Langenau, Baden-Wurttemberg, Germany

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LEO Pharma Investigational Site

Limburg an der Lahn, Hesse, Germany

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LEO Pharma Investigational Site

Wiesbaden, Hesse, Germany

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LEO Pharma Investigational Site

Lohne, Lower Saxony, Germany

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LEO Pharma Investigational Site

Mainz, Rhineland-Palatinate, Germany

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LEO Pharma Investigational Site

Kiel, Schleswig-Holstein, Germany

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LEO Pharma Investigational Site

Berlin, State of Berlin, Germany

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LEO Pharma Investigational Site

Bad Bentheim, , Germany

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Bielefeld, , Germany

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Hamburg, , Germany

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Memmingen, , Germany

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LEO Pharma Investigational Site

Münster, , Germany

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Oldenburg, , Germany

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LEO Pharma Investigational Site

Osnabrück, , Germany

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LEO Pharma Investigational Site

Heraklion, Crete, Greece

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LEO Pharma Investigational Site

Athens, , Greece

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LEO Pharma Investigational Site

Athens, , Greece

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LEO Pharma Investigational Site

Piraeus, , Greece

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LEO Pharma Investigational Site

Thessaloniki, , Greece

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LEO Pharma Investigational Site

Thessaloniki, , Greece

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Thessaloniki, , Greece

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LEO Pharma Investigational Site

Debrecen, , Hungary

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Orosháza, , Hungary

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Szolnok, , Hungary

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Veszprém, , Hungary

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Ancona, , Italy

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Bologna, , Italy

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Brescia, , Italy

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Coppito, , Italy

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Modena, , Italy

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Napoli, , Italy

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Parma, , Italy

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Pavia, , Italy

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Roma, , Italy

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Roma, , Italy

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LEO Pharma Investigational Site

Rozzano, , Italy

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LEO Pharma Investigational Site

Beek, , Netherlands

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LEO Pharma Investigational Site

Iwonicz-Zdrój, , Poland

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LEO Pharma Investigational Site

Lodz, , Poland

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LEO Pharma Investigational Site

Lodz, , Poland

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LEO Pharma Investigational Site

Lublin, , Poland

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Lublin, , Poland

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LEO Pharma Investigational Site

Poznan, , Poland

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LEO Pharma Investigational Site

Skierniewice, , Poland

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LEO Pharma Investigational Site

Warsaw, , Poland

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LEO Pharma Investigational Site

Warsaw, , Poland

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LEO Pharma Investigational Site

Warsaw, , Poland

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LEO Pharma Investigational Site

Wroclaw, , Poland

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LEO Pharma Investigational Site

Wroclaw, , Poland

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LEO Pharma Investigational Site

Wroclaw, , Poland

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LEO Pharma Investigational Site

Alicante, , Spain

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LEO Pharma Investigational Site

Badalona, , Spain

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LEO Pharma Investigational Site

Barcelona, , Spain

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Barcelona, , Spain

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LEO Pharma Investigational Site

Granada, , Spain

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LEO Pharma Investigational Site

Manises, , Spain

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LEO Pharma Investigational Site

Pontevedra, , Spain

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LEO Pharma Investigational Site

Pozuelo de Alarcón, , Spain

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LEO Pharma Investigational Site

Santiago de Compostela, , Spain

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LEO Pharma Investigational Site

Valencia, , Spain

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LEO Pharma Investigational Site

Villajoyosa, , Spain

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LEO Pharma Investigational Site

Chorley, , United Kingdom

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LEO Pharma Investigational Site

Corby, , United Kingdom

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LEO Pharma Investigational Site

Corby, , United Kingdom

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LEO Pharma Investigational Site

Coventry, , United Kingdom

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LEO Pharma Investigational Site

Liverpool, , United Kingdom

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LEO Pharma Investigational Site

London, , United Kingdom

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LEO Pharma Investigational Site

London, , United Kingdom

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LEO Pharma Investigational Site

Northwood, , United Kingdom

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LEO Pharma Investigational Site

Shipley, , United Kingdom

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Countries

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Belgium Czechia France Germany Greece Hungary Italy Netherlands Poland Spain United Kingdom

Other Identifiers

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2017-004998-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1282-4507

Identifier Type: OTHER

Identifier Source: secondary_id

2023-509668-11-00

Identifier Type: CTIS

Identifier Source: secondary_id

LP0160-1329

Identifier Type: -

Identifier Source: org_study_id