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
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Kozni ambulance Kutna Hora s.r.o. Coordinator of this site? Confirm its status | Hlouska | Czechia | Completed |
| Nemocnice AGEL Nový Jičín a.s. Coordinator of this site? Confirm its status | Nový Jičín | Czechia | Completed |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Completed |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Completed |
| Klinikum Bielefeld gGmbH Coordinator of this site? Confirm its status | Bielefeld | Germany | Completed |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| Studienzentrum Dr.Beate Schwarz Coordinator of this site? Confirm its status | Langenau | Germany | Completed |
| Siteworks GmbH Coordinator of this site? Confirm its status | Lohne (oldenburg) | Germany | Completed |
| BAG Dres. med. Quist PartG Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Beldio Research Gmbh Coordinator of this site? Confirm its status | Memmingen | Germany | Completed |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| Klinikum Oldenburg Aor Coordinator of this site? Confirm its status | Oldenburg | Germany | Completed |
| Klinische Forschung Osnabrueck Coordinator of this site? Confirm its status | Osnabrueck | Germany | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Vall D'hebron Institut De Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Completed |
| Hospital de Manises Coordinator of this site? Confirm its status | Manises | Spain | Completed |
| Complexo Hospitalario Universitario de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Marina Baixa De La Vila Joiosa Coordinator of this site? Confirm its status | Villajoyosa | Spain | Completed |
| Centre Hospitalier Universitaire Amiens - Picardie Coordinator of this site? Confirm its status | Amiens | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Centre Hospitalier Valence Coordinator of this site? Confirm its status | Valence | France | Completed |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | Chorley | United Kingdom | Unknown status |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | Corby | United Kingdom | Unknown status |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | Northwood | United Kingdom | Unknown status |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | Shipley | United Kingdom | Unknown status |
| Andreas Syngros Hospital Of Venereal And Dermatological Diseases Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Completed |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Completed |
| Geniko Nosokomeio Peiraia Tzaneio Coordinator of this site? Confirm its status | Piraeus | Greece | Completed |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Dermamed Research Kft. Coordinator of this site? Confirm its status | Orosháza | Hungary | Completed |
| Allergo-Derm Bakos Kft Coordinator of this site? Confirm its status | Szolnok | Hungary | Completed |
| Medmare Bt. Coordinator of this site? Confirm its status | Veszprém | Hungary | Completed |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| Azienda Sanitaria Locale Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | L'aquila | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Completed |
| Policlinico Universitario Agostino Gemelli IRCCS Università Cattolica Del Sacro Cuore Coordinator of this site? Confirm its status | Roma | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| LEO Pharma Investigational Site Coordinator of this site? Confirm its status | Beek | Netherlands | Unknown status |
| Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o. Coordinator of this site? Confirm its status | Iwonicz-Zdroj | Poland | Completed |
| Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Pro Life Medica Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Ko-Med Nova Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Solumed Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Clinmedica Research sp. z o.o. Coordinator of this site? Confirm its status | Skierniewice | Poland | Completed |
| Trialmed Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Klinika Ambroziak Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.