Status:
COMPLETED
Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
Brief Summary
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 t...
Detailed Description
Brodalumab is an anti-IL-17 receptor antibody and blocks the inflammatory effects of IL-17 in the skin. Some psoriasis patients with a higher body weight experienced a lower treatment effect of brodal...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2026
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT04306315
Start Date
August 16 2022
End Date
January 5 2026
Last Update
January 8 2026
Active Locations (81)
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1
LEO Pharma Investigational Site
Brussels, Belgium, 1200
2
LEO Pharma Investigational Site
Ham-sur-Heure-Nalinnes, Belgium, 6120
3
LEO Pharma Investigational Site
Leuven, Belgium, 3000
4
LEO Pharma Investigational Site
Liège, Belgium, B-4000