2023-509668-11-00招募中4 期
Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and ≥120 kg body weight; ADJUST - Phase 4 – efficacy, A randomised, double-blind, controlled, parallel group, multi-centre trial
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 62
- 主要终点
- Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Investigator, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
次要结局
- 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) of 0 or 1 at both Weeks 40 and 52.
- Having 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.
研究者
LEO Pharma Clinical Trials mailbox
Scientific
Leo Pharma A/S
研究点 (62)
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