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NCT04306315CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 24 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
385 (actual)
First submitted
11 Mar 2020
Start date
21 Jul 2022
Primary completion date
25 Aug 2025
Lead sponsor
LEO Pharma
Diseases
Psoriasis
NCT number
NCT04306315
EU CT number
2023-509668-11-00
EudraCT number
2017-004998-13

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 385
  • From 21 Jul 2022 to the primary completion date, 25 Aug 2025
  • 70 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (70)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Grand Hopital de Charleroi
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CharleroiBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Kozni ambulance Kutna Hora s.r.o.
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HlouskaCzechiaCompleted
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaCompleted
Fakultni Nemocnice Plzen
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Plzen 3CzechiaCompleted
Thermalsole und Schwefelbad Bentheim GmbH
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Bad BentheimGermanyCompleted
Klinikum Bielefeld gGmbH
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BielefeldGermanyCompleted
University Medical Center Hamburg-Eppendorf
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HamburgGermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyCompleted
Studienzentrum Dr.Beate Schwarz
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LangenauGermanyCompleted
Siteworks GmbH
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Lohne (oldenburg)GermanyCompleted
BAG Dres. med. Quist PartG
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MainzGermanyCompleted
Beldio Research Gmbh
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MemmingenGermanyCompleted
Universitaetsklinikum Muenster AöR
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MuensterGermanyCompleted
Klinikum Oldenburg Aor
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OldenburgGermanyCompleted
Klinische Forschung Osnabrueck
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OsnabrueckGermanyCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Vall D'hebron Institut De Recerca
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BarcelonaSpainCompleted
Hospital Universitario Virgen de las Nieves
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GranadaSpainCompleted
Hospital de Manises
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ManisesSpainCompleted
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital General Universitario de Valencia
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ValenciaSpainCompleted
Hospital Marina Baixa De La Vila Joiosa
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VillajoyosaSpainCompleted
Centre Hospitalier Universitaire Amiens - Picardie
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AmiensFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Centre Hospitalier Valence
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ValenceFranceCompleted
LEO Pharma Investigational Site
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ChorleyUnited KingdomUnknown status
LEO Pharma Investigational Site
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CorbyUnited KingdomUnknown status
LEO Pharma Investigational Site
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CoventryUnited KingdomUnknown status
LEO Pharma Investigational Site
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LiverpoolUnited KingdomUnknown status
LEO Pharma Investigational Site
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LondonUnited KingdomUnknown status
LEO Pharma Investigational Site
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NorthwoodUnited KingdomUnknown status
LEO Pharma Investigational Site
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ShipleyUnited KingdomUnknown status
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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AthensGreeceCompleted
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
Geniko Nosokomeio Peiraia Tzaneio
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PiraeusGreeceCompleted
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
University of Debrecen
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DebrecenHungaryCompleted
Dermamed Research Kft.
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OrosházaHungaryCompleted
Allergo-Derm Bakos Kft
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SzolnokHungaryCompleted
Medmare Bt.
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VeszprémHungaryCompleted
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Azienda Ospedaliero Universitaria Parma
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ParmaItalyCompleted
Policlinico Universitario Agostino Gemelli IRCCS Università Cattolica Del Sacro Cuore
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RomaItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Humanitas Mirasole S.p.A.
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RozzanoItalyCompleted
LEO Pharma Investigational Site
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BeekNetherlandsUnknown status
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o.
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Iwonicz-ZdrojPolandCompleted
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
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LodzPolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Pro Life Medica Sp. z o.o.
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LublinPolandCompleted
Ko-Med Nova Sp. z o.o.
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LublinPolandCompleted
Solumed Sp. z o.o. sp.k.
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PoznanPolandCompleted
Clinmedica Research sp. z o.o.
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SkierniewicePolandCompleted
Trialmed Sp. z o.o.
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WarsawPolandCompleted
Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
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WarsawPolandCompleted
Klinika Ambroziak Sp. z o.o.
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WarsawPolandCompleted
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
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WroclawPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
dermMedica Sp. z o.o
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WroclawPolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.