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Heavier psoriasis patients may need a stronger dose of brodalumab

NCT ID NCT04306315

Disease control Sponsor: LEO Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a higher dose of the drug brodalumab works better than the standard dose for people with moderate-to-severe plaque psoriasis who weigh at least 120 kg. The trial involved 385 adults and lasted 52 weeks. The main goal was to see if more patients on the higher dose achieved at least 90% clearer skin by week 40.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brodalumab (a biologic drug that blocks inflammation in the skin)
What this could lead to
If successful, this could lead to a better dosing strategy for psoriasis patients who weigh over 120 kg, helping more of them achieve clear or nearly clear skin.
What could go wrong
This is a Phase 4 study, so the drug is already approved. However, the adjusted dose may not work better than the standard dose, and higher doses could increase side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

385 people

The number who actually took part.

Started

Jul 2022

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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. Key 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.

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psoriasis vulgaris

Contacts and locations

Locations

  • LEO Pharma Investigational Site

    Brussels, 1200, Belgium

  • LEO Pharma Investigational Site

    Ham-sur-Heure-Nalinnes, 6120, Belgium

  • LEO Pharma Investigational Site

    Leuven, 3000, Belgium

  • LEO Pharma Investigational Site

    Liège, B-4000, Belgium

  • LEO Pharma Investigational Site

    Kutná Hora, 284 01, Czechia

  • LEO Pharma Investigational Site

    Nový Jičín, 741 01, Czechia

  • LEO Pharma Investigational Site

    Plzen-Bory, 305 99, Czechia

  • LEO Pharma Investigational Site

    Amiens, Somme, 80054, France

  • LEO Pharma Investigational Site

    Saint-Priest-en-Jarez, 42270, France

  • LEO Pharma Investigational Site

    Toulouse, 31059, France

  • LEO Pharma Investigational Site

    Valence, 13616, France

  • LEO Pharma Investigational Site

    Langenau, Baden-Wurttemberg, 89129, Germany

  • LEO Pharma Investigational Site

    Limburg an der Lahn, Hesse, 56242, Germany

  • LEO Pharma Investigational Site

    Wiesbaden, Hesse, 65189, Germany

  • LEO Pharma Investigational Site

    Lohne, Lower Saxony, 49393, Germany

  • LEO Pharma Investigational Site

    Mainz, Rhineland-Palatinate, 55128, Germany

  • LEO Pharma Investigational Site

    Kiel, Schleswig-Holstein, 24105, Germany

  • LEO Pharma Investigational Site

    Berlin, State of Berlin, 10117, Germany

  • LEO Pharma Investigational Site

    Bad Bentheim, 48455, Germany

  • LEO Pharma Investigational Site

    Bielefeld, 33647, Germany

  • LEO Pharma Investigational Site

    Hamburg, 20246, Germany

  • LEO Pharma Investigational Site

    Memmingen, 87700, Germany

  • LEO Pharma Investigational Site

    Münster, 48149, Germany

  • LEO Pharma Investigational Site

    Oldenburg, 26133, Germany

  • LEO Pharma Investigational Site

    Osnabrück, 49074, Germany

  • LEO Pharma Investigational Site

    Heraklion, Crete, 711 10, Greece

  • LEO Pharma Investigational Site

    Athens, 115 25, Greece

  • LEO Pharma Investigational Site

    Athens, 16121, Greece

  • LEO Pharma Investigational Site

    Piraeus, 185 36, Greece

  • LEO Pharma Investigational Site

    Thessaloniki, 546 43, Greece

  • LEO Pharma Investigational Site

    Thessaloniki, 54643, Greece

  • LEO Pharma Investigational Site

    Thessaloniki, 56403, Greece

  • LEO Pharma Investigational Site

    Debrecen, 4032, Hungary

  • LEO Pharma Investigational Site

    Orosháza, 5900, Hungary

  • LEO Pharma Investigational Site

    Szolnok, 5000, Hungary

  • LEO Pharma Investigational Site

    Veszprém, 8200, Hungary

  • LEO Pharma Investigational Site

    Ancona, 60020, Italy

  • LEO Pharma Investigational Site

    Bologna, 40138, Italy

  • LEO Pharma Investigational Site

    Brescia, 25123, Italy

  • LEO Pharma Investigational Site

    Coppito, 67100, Italy

  • LEO Pharma Investigational Site

    Modena, 41124, Italy

  • LEO Pharma Investigational Site

    Naples, 80131, Italy

  • LEO Pharma Investigational Site

    Parma, 43126, Italy

  • LEO Pharma Investigational Site

    Pavia, 27100, Italy

  • LEO Pharma Investigational Site

    Roma, 00133, Italy

  • LEO Pharma Investigational Site

    Roma, 00168, Italy

  • LEO Pharma Investigational Site

    Rozzano, 20089, Italy

  • LEO Pharma Investigational Site

    Beek, 6191 JW, Netherlands

  • LEO Pharma Investigational Site

    Iwonicz-Zdrój, 38-440, Poland

  • LEO Pharma Investigational Site

    Lodz, 90-242, Poland

  • LEO Pharma Investigational Site

    Lodz, 90-436, Poland

  • LEO Pharma Investigational Site

    Lublin, 20-362, Poland

  • LEO Pharma Investigational Site

    Lublin, 20-412, Poland

  • LEO Pharma Investigational Site

    Poznan, 60-529, Poland

  • LEO Pharma Investigational Site

    Skierniewice, 96-100, Poland

  • LEO Pharma Investigational Site

    Warsaw, 02-482, Poland

  • LEO Pharma Investigational Site

    Warsaw, 02-758, Poland

  • LEO Pharma Investigational Site

    Warsaw, 02-801, Poland

  • LEO Pharma Investigational Site

    Wroclaw, 50-566, Poland

  • LEO Pharma Investigational Site

    Wroclaw, 51-318, Poland

  • LEO Pharma Investigational Site

    Wroclaw, 52-416, Poland

  • LEO Pharma Investigational Site

    Alicante, 03010, Spain

  • LEO Pharma Investigational Site

    Badalona, 08916, Spain

  • LEO Pharma Investigational Site

    Barcelona, 08025, Spain

  • LEO Pharma Investigational Site

    Barcelona, 08035, Spain

  • LEO Pharma Investigational Site

    Granada, 18014, Spain

  • LEO Pharma Investigational Site

    Manises, 46940, Spain

  • LEO Pharma Investigational Site

    Pontevedra, 36001, Spain

  • LEO Pharma Investigational Site

    Pozuelo de Alarcón, 28223, Spain

  • LEO Pharma Investigational Site

    Santiago de Compostela, 15706, Spain

  • LEO Pharma Investigational Site

    Valencia, 46014, Spain

  • LEO Pharma Investigational Site

    Villajoyosa, 03570, Spain

  • LEO Pharma Investigational Site

    Chorley, PR7 7NA, United Kingdom

  • LEO Pharma Investigational Site

    Corby, NN17 2UR, United Kingdom

  • LEO Pharma Investigational Site

    Corby, NN18 9EZ, United Kingdom

  • LEO Pharma Investigational Site

    Coventry, CV3 4FJ, United Kingdom

  • LEO Pharma Investigational Site

    Liverpool, L22 0LG, United Kingdom

  • LEO Pharma Investigational Site

    London, BR5 3QG, United Kingdom

  • LEO Pharma Investigational Site

    London, E1 2ES, United Kingdom

  • LEO Pharma Investigational Site

    Northwood, HA6 2RN, United Kingdom

  • LEO Pharma Investigational Site

    Shipley, BD18 35A, United Kingdom

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