NCT04306315.

Study name	Adjusted brodalumab dose compared with standard brodalumab dose in subjects with moderate‐to‐severe plaque psoriasis and ≥ 120 kg body weight (ADJUST)
Methods	RCT, placebo‐controlled, double‐blind trial, parallel arms Phase 4 Location: ?
Participants	Randomised: 384 participants 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 current active tuberculosis 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
Interventions	Intervention A. Brodalumab 210 mg + brodalumab 70 mg add‐on (subcutaneously at week 0, week 1, and week 2, and then once every 2 weeks. Participants not fulfilling a predefined response at any visit with efficacy assessments after week 16 will receive a dose adjustment to 280 mg brodalumab every 2 weeks) Control intervention B. Brodalumab 210 mg + placebo add‐on (subcutaneously at week 0, week 1, and week 2, and then once every 2 weeks. Participants not fulfilling a predefined response at any time visit with efficacy assessments week 16 will receive a dose adjustment to 210 mg brodalumab + placebo every 2 weeks)
Outcomes	Primary outcome : Having at least 90% lower PASI score relative to baseline (PASI 90 response) at week 40 Secondary outcomes : 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 PASI 100 response at week 40 and week 52 Change from baseline at weeks 40 and 52 in PASI score Change from baseline at weeks 40 and 52 in affected BSA Having DLQI total score of 0 or 1 at week 40 and week 52 Having DLQI total score of 0 or 1 at week 52 Change from baseline at weeks 40 and 52 in DLQI total score
Starting date	Estimated study start date: June 2020 Estimated study completion date: August 2024 Last update posted: April 2020, not yet recruiting
Contact information	LEO Pharma raleodk@leo‐pharma.com
Notes	Ongoing study Funding: LEO Pharma Last checked in September 2020