Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and =120 kg Body Weight
- Conditions
- Psoriasis Vulgaris
- Registration Number
- NCT04306315
- Lead Sponsor
- LEO Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> - Signed and dated informed consent has been obtained prior to any protocol-related<br> procedures.<br><br> - Age =18 to <75 years at the time of screening.<br><br> - Diagnosed with chronic plaque psoriasis at least 6 months before randomisation.<br><br> - Body weight =120 kg at the time of screening.<br><br> - Moderate-to-severe plaque psoriasis as defined by: BSA =10% and PASI =12 at<br> screening and baseline.<br><br> - No evidence of active or latent tuberculosis according to local standard of care.<br><br>Key Exclusion Criteria:<br><br> - Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,<br> medication-induced psoriasis, or other skin conditions (e.g., eczema) that would<br> interfere with evaluations of the effect of the investigational medicinal product<br> (IMP) on participants with plaque psoriasis.<br><br> - Clinically important active infections or infestations, chronic, recurrent or latent<br> infections or infestations, or is immunocompromised (e.g., human immunodeficiency<br> virus, hepatitis B, and hepatitis C).<br><br> - Any systemic disease considered by the investigator to be uncontrolled and either<br> immunocompromising the participants and/or placing the participant at undue risk of<br> intercurrent diseases (including, but not limited to, renal failure, heart failure,<br> liver disease, diabetes, and anaemia).<br><br> - History of Crohn's disease.<br><br> - Myocardial infarction or stroke, or unstable angina pectoris within the past 12<br> months.<br><br> - Any active malignancy.<br><br> - History of malignancy within 5 years, except for treated and considered cured<br> cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ<br> breast ductal carcinoma.<br><br> - History of suicidal behaviour (i.e., 'actual suicide attempt', 'interrupted<br> attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the<br> Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or at<br> baseline.<br><br> - Any suicidal ideation of category 4 or 5 ('active suicidal ideation with some intent<br> to act, without specific plan' or ' active suicidal ideation with specific plan and<br> intent') based on the C-SSRS questionnaire at screening or at baseline.<br><br> - A Patient Health Questionnaire (PHQ)-8 score of =10 corresponding to<br> moderate-to-severe depression at screening or at baseline.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
- Secondary Outcome Measures
Name Time Method Having static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 40;Having PASI 90 response at Week 52;Having sPGA score of 0 or 1 at Week 52;Having sPGA of genitalia (sPGA-G) score of 0 or 1 at both Week 40 and Week 52;Having sPGA of genitalia (sPGA-G) score of 0 or 1 at Week 40;Having sPGA-G score of 0 or 1 at Week 52;Having PASI 100 response at Week 40;Having PASI 100 response at Week 52;Change from baseline at Weeks 40 and 52 in PASI score;Change from baseline at Weeks 40 and 52 in affected body surface area (BSA);Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40;Having DLQI total score of 0 or 1 at Week 52;Change from baseline at Weeks 40 and 52 in DLQI total score;Number of Participants Experiencing Adverse Events (AEs) up to Week 58.