Adjusted brodalumab dose compared with standard brodalumab dose in subjects with moderate-to-severe plaque psoriasis and =120 kg body weight; ADJUST
- Conditions
- Moderate-to-severe plaque psoriasis and a body weight =120 kg.MedDRA version: 20.0Level: LLTClassification code: 10071117Term: Plaque psoriasis Class: 10040785Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-509668-11-00
- Lead Sponsor
- eo Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 384
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 as determined by the investigator., 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 for patients requiring initiation of a biologic treatment.
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 subjects with plaque psoriasis., A Patient Health Questionnaire (PHQ)-8 score of =10 corresponding to moderate-to-severe depression at screening or at baseline., 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 subject and/or placing the subject at undue risk of intercurrent diseases (including, but not limited to, renal failure, heart failure, liver disease, diabetes, and anaemia)., Known 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect on psoriasis symptoms of an adjustable brodalumab dosage regimen to standard brodalumab treatment in subjects with moderate-to severe psoriasis and a body weight =120 kg;Secondary Objective: To evaluate the safety of an adjustable brodalumab dosage regimen in subjects with moderate-to-severe psoriasis and a body weight =120 kg., To evaluate pharmacokinetics (PK) of brodalumab in subjects with moderateto- severe psoriasis and a body weight =120 kg., To explore the effect of brodalumab on systemic inflammation in subjects with moderate-to-severe psoriasis and a body weight =120 kg., To explore the effect of brodalumab on skin and subcutaneous adipose tissue inflammation in subjects with moderate-to-severe psoriasis and a body weight =120 kg.;Primary end point(s): 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 Secondary end point(s):Having static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 40.;Secondary end point(s):Having PASI 90 response at Week 52.;Secondary end point(s):Having sPGA score of 0 or 1 at Week 52.;Secondary end point(s):Having sPGA of genitalia (sPGA-G) of 0 or 1 at both Weeks 40 and 52.;Secondary end point(s):Having sPGA-G score of 0 or 1 at Week 40.;Secondary end point(s):Having sPGA-G score of 0 or 1 at Week 52.;Secondary end point(s):Having PASI 100 response at Week 40.;Secondary end point(s):Having PASI 100 response at Week 52.;Secondary end point(s):Change from baseline at Weeks 40 and 52 in PASI score.;Secondary end point(s):Change from baseline at Weeks 40 and 52 in affected body surface area (BSA).;Secondary end point(s):Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40.;Secondary end point(s):Having DLQI total score of 0 or 1 at Week 52.;Secondary end point(s):Change from baseline at Weeks 40 and 52 in DLQI total score.