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.
Who can participate
Age range18 Years – 74 Years
SexALL
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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 trea…
What they're measuring
1
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.