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

3 1 1

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
Hospital General Universitario De Valencia Valencia Spain
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Klinische Forschung Osnabrueck Osnabrück Germany
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o. Iwonicz-Zdroj Poland
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
BAG Dres. med. Quist PartG Mainz Germany
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
Studienzentrum Dr. Beate Schwarz Langenau Germany
Cviebubus Ujjokzawwkkpqv Scmoyrzup Woluwe-Saint-Lambert Belgium
Ucrjrvusez Ox Ddajnbzr Debrecen Hungary
Cfpevzfjsx Pvdlvjmxdxt Lavpvvuxwujlployhoebtwp Mycqqmvp squrs Wroclaw Poland
Haqeuusv Vekr dfisltfi Barcelona Spain
Usuwrqcehqlrlgkxq Pqjrjqofmnv Dhgnc Mrfexz Ancona Italy
Uahfbvobizun Df Specajtl Db Cjflzwzhbh Santiago De Compostela Spain
Uusovpwyglqmpkbwodzvx Mzhspwha Aiq Munster Germany
Acpstph Ocmuhcptzez Uktfaqpbnmyvr Fhivwzeb Ii Dx Nfhiud Naples Italy
Nbdmwyrxd Atsc Nhpn Jclxz adkj Novy Jicin Czechia
Cfbwkk Hijngytexvk Ukqwrdasgplbf Apbrwt Pmmrczop Amiens France
Afgndsr Utdcw Shdgtgpvm Lnqscl Dd Bietmzf Bologna Italy
Uosygcnqfj Mdcsicc Csqeru Hupnfpjcyhkwidonz Hamburg Germany
Unukdlbeishznnqwxpjml Sbhsmoykbjpluyilur Awd Kiel Germany
Umrljdpncf Dttsk Syuea Dk Bfbteuj Brescia Italy
Cjgrjtsd Hnkvdwxskdms Ukmklvblpaazj Di Pmlacfqdqi Pontevedra Spain
Ukaixodcds Gaxnajd Hfgmfeug Oe Horcizgfh Heraklion Greece
Hatsfrqc Uyseocarlywin Vmzskw Dw Lwh Nzrtzd Granada Spain
Ilqtqynsoa Gkmfoef Hgtaigwu Ow Touzgbivzwjg Thessaloniki Greece
Khryykd Aktyezezo Sre z otio Warsaw Poland
Dmiwqfgr Rwmeiyxo Kogl Oroshaza Hungary
Ksobyjyy Oizdxdsay Aqz Oldenburg In Holstein Germany
Flthjhvq Nvhaaothr Pchqw Plzen Czechia
Annulvxuspao Bbrqd Kydp Szolnok Hungary
Gxsahay Hwggtoci Ol Tnvcserohvwx Pcaldrtiivdv Thessaloniki Greece
Pstaanj Mzsruj Sjd z Ovfk Ewp Pvbwwngkt Poniatowa Poland
Cgttskxrcv Rwhqfsll shy z otev Skierniewice Poland
Ivtzjrpu do Cosdqdcphzue Hxflwvdcfmu Uguttibnvozzj dj Sepqx Eikmcuw (zwahwug Saint Priest En Jarez France
Twovyrrt Ssg z osmb Piotrkow Trybunalski Poland
Acryyml Spdlxzh Hyrjsopc Ot Vzkitlha Aas Dpmztkxfhzddyb Duikjztt Athens Greece
Kuborp Ckzmcw Kizoevtgq Smo z orbf Zamosc Poland
Sfxswfijq Gofg Hanover Germany
Dwyqxkpjxj Sjp z orhf Wroclaw Poland
Awzijtc Oucpjblvjow Udoafpncyhbfi Pdnus Parma Italy
Gpeqr Hrjjbvx Dh Cwuktwfra Charleroi Belgium
Tqmlhfjugxk usn Skxgsegarfg Bqjnowcs Gyqq Bad Bentheim Germany
Cgedyr Hjcffiaoslp Vspwnvo Valence France
Hssoixwe Moorgc Bdhlc Dd Lc Vpzq Jimgri Villajoyosa Spain
Spdtyss Sxb z ojfg sjpiz Poznan Poland
Ckkikgc Mgctzsds Ouvzbk Wroclaw Poland
Bvvucj Rbtbhpcp Gwnp Memmingen Germany
Kxjlywei Biascahsi ggwoi Bielefeld Germany
Agwlizk Svhzbnxva Lghvbg Autsaiqk Slxjyek Lxrwpfkgahwfum L'aquila Italy
Hgncqfyu Ubflusrgrpink Hznzznvt Ttthq y Phunre Ibbgtldx Cbfful debfvwsxmzpnvlvpv (whdx Badalona Spain
Krvvv arwtovnlf Koghm Hqda stffnc Hlouska Czechia
Mnppdbv Bip Veszprem Hungary

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.

Investigated Diseases:

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)

Other Trials to Consider

  • A study to evaluate the effectiveness and safety of zasocitinib in children and adolescents with moderate-to-severe plaque psoriasis

    Recruiting

    3 1
    Investigated Diseases:
    Investigated Drugs:
    Germany Italy Poland Spain
  • Long-term safety study of deucravacitinib compared to ustekinumab in adults with moderate to severe plaque psoriasis

    Recruiting

    3 1 1 1
    Belgium Bulgaria Czechia Denmark France Germany +6