Study on Adjustable Brodalumab Dosage for Patients with Moderate-to-Severe Plaque Psoriasis Weighing 120 kg or More

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What is this study about?

This clinical trial is focused on studying the effects of a medication called brodalumab in individuals with moderate-to-severe plaque psoriasis, a skin condition that causes red, scaly patches. The study is specifically for those who weigh 120 kg or more. Brodalumab is administered as a solution for injection using a pre-filled syringe. The trial will compare two different dosing regimens of brodalumab: an adjustable dose and a standard dose. There is also a placebo group involved in the study.

The purpose of the study is to evaluate how well the adjustable dosing regimen of brodalumab works compared to the standard dosing regimen in reducing the symptoms of psoriasis. Participants will receive treatment over a period of 52 weeks. Throughout the study, the effectiveness of the treatment will be assessed by observing changes in the severity and extent of psoriasis symptoms.

Participants will be monitored regularly to track their progress and any changes in their condition. The study aims to determine if the adjustable dosing regimen can provide better control of psoriasis symptoms compared to the standard dosing regimen. This information could help improve treatment options for individuals with moderate-to-severe plaque psoriasis.

1 initial treatment phase

The trial begins with the administration of brodalumab or a placebo. The medication is provided as a solution for injection in a pre-filled syringe.

The initial dosage is 210 mg of brodalumab, administered once a week for the first three weeks.

2 adjustment phase

After the initial phase, the dosage may be adjusted based on the response to the treatment.

The goal is to compare the effects of an adjustable dosage regimen with a standard treatment regimen.

3 maintenance phase

Following the adjustment phase, the treatment continues with the maintenance dosage.

The standard maintenance dosage is 210 mg every two weeks.

4 evaluation phase

The primary goal is to achieve a 90% reduction in the Psoriasis Area and Severity Index (PASI) score by Week 40.

Secondary goals include achieving a static Physician’s Global Assessment (sPGA) score of 0 or 1 and a PASI 100 response by Week 52.

5 completion of trial

The trial is expected to last for 52 weeks.

The final assessments will be conducted to evaluate the overall effectiveness and impact on quality of life.

Who Can Join the Study?

  • You must have signed and dated a form that shows you agree to participate in the study before any study-related procedures begin.
  • You need to be between 18 and 74 years old at the time of the screening.
  • You should have been diagnosed with chronic plaque psoriasis for at least 6 months before joining the study. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • Your body weight must be at least 120 kg at the time of screening.
  • You must have moderate-to-severe plaque psoriasis, which means that the psoriasis affects at least 10% of your body surface area (BSA) and you have a Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and baseline. PASI is a tool used to measure the severity of psoriasis.
  • You should not have any signs of active or hidden tuberculosis, which is a serious lung infection, according to the local standard of care for patients starting a biologic treatment. Biologic treatment is a type of medication that targets specific parts of the immune system.

Who Cannot Join the Study?

  • Having a body weight of less than 120 kg (about 265 pounds).
  • Not having moderate-to-severe plaque psoriasis, which is a skin condition that causes red, scaly patches on the skin.
  • Being under the age of 18 or over the age of 65.
  • Being part of a vulnerable population, which means needing special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Grand Hopital De Charleroi Charleroi Belgium
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
University General Hospital Of Heraklion Heraklion Greece
Hospital Marina Baixa De La Vila Joiosa Villajoyosa Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Solumed Sp. z o.o. sp.k. Poznan Poland
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Centrum Medyczne Oporow Wroclaw Poland
Beldio Research GmbH Memmingen Germany
Klinikum Bielefeld gGmbH Bielefeld Germany
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o. Iwonicz-Zdroj Poland
Siteworks GmbH Hanover Germany
Fakultni Nemocnice Plzen Plzen Czechia
University Of Debrecen Debrecen Hungary
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Clinmedica Research sp. z o.o. Skierniewice Poland
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Universita Degli Studi Di Brescia Brescia Italy
Klinische Forschung Osnabrueck Osnabrück Germany
Allergo-Derm Bakos Kft. Szolnok Hungary
DermaMed Research Kft. Oroshaza Hungary
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
Vital Medical Center Veszprem Hungary
Cvgqdiagk Uibucfsrapzbsf Szoevmzsc Woluwe-Saint-Lambert Belgium
Aqesywl Ouifwsvbkci Utmdmhomrfgio Pnfnz Parma Italy
Uonynfozty Mnuysar Cddqqd Hpskuwzgqzdjrfoqc Hamburg Germany
Trlnpthmrne ulv Svbgwxqmqgh Bhunbqth Gwsh Bad Bentheim Germany
Cpuvny Hazpzqgprpr Vgpkuzs Valence France
Awmbdxo Sdomrromv Lukiee Alcevtmj Stqslve Lcbxqgmxiaprel L'aquila Italy
Tyiqdfrn Sgw z oovj Piotrkow Trybunalski Poland
Powjrgs Muafev Swf z Ofke Epj Pecuqxtok Poniatowa Poland
Uymbvkrawptkpmsxojakm Mmjqvbdo Asl Munster Germany
Awhusuh Uzlhi Ssezeeadc Lltnex Dq Bztqopb Bologna Italy
Djjlusifvn Sez z oesr Wroclaw Poland
Hifjyymf Uinhoswboofsz Hfwuaejk Tbvff y Pqxlph Ibcphycw Cxkkxr digvdoibdmsqqakgw (rmov Badalona Spain
Ioklnfjs dc Csxswecuuuck Hxsryurumqe Uvqxceslrhqio db Sbqmb Esgipek (xaaghwx Saint Priest En Jarez France
Hqeeojdh Vpen dbprzzyk Barcelona Spain
Dooortamcxji Qpnno Mainz Germany
Kwtge azrudtdkg Ktpxh Hkpr shywab Hlouska Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
21.07.2022
Czechia Czechia
Not recruiting
21.07.2022
France France
Not recruiting
21.07.2022
Germany Germany
Not recruiting
21.07.2022
Greece Greece
Not recruiting
21.07.2022
Hungary Hungary
Not recruiting
21.07.2022
Italy Italy
Not recruiting
21.07.2022
Poland Poland
Not recruiting
21.07.2022
Spain Spain
Not recruiting
21.07.2022

Trial locations

Investigated drugs:

Brodalumab is a medication used in this clinical trial to treat moderate-to-severe plaque psoriasis. It works by blocking certain proteins in the body that can cause inflammation and lead to the symptoms of psoriasis. The trial is comparing two different ways of using this medication: an adjustable dosage regimen and a standard treatment regimen. The goal is to see which method is more effective in reducing psoriasis symptoms in patients who weigh 120 kg or more.

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition that causes the rapid growth of skin cells, leading to the formation of scales and red patches that can be itchy and sometimes painful. It is the most common form of psoriasis and typically appears as raised, inflamed, and scaly patches on the skin. These patches, or plaques, are often found on the elbows, knees, scalp, and lower back, but they can appear anywhere on the body. The condition can vary in severity, with some individuals experiencing only minor patches, while others may have more extensive skin involvement. The progression of plaque psoriasis can be unpredictable, with periods of remission and flare-ups. Factors such as stress, infections, and certain medications can trigger or worsen the symptoms.

Trial ID:
2023-509668-11-00
Protocol code:
LP0160-1329
NCT ID:
NCT04306315
Trial Phase:
Therapeutic confirmatory (Phase III)

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