2024-510753-10-00已完成3 期
A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies
Amgen Inc.68 个研究点 分布在 12 个国家目标入组 176 人开始时间: 2024年12月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 68
- 主要终点
- Achieving reduction from baseline in weekly average of daily itching score at specified time points.
研究概览
简要总结
To evaluate the efficacy of different doses of rocatinlimab compared with placebo at specified timepoints on the PRO measure of pruritus
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent before initiation of any study-specific activities/procedures.
- •Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- •A clinical diagnosis of prurigo nodularis (as defined by core symptoms according to the United States expert panel consensus [Elmariah et al, 2021]), that has been present for at least 3 months before signing of informed consent. The prurigo nodularis defined core symptoms include pruritus for more than 6 weeks, evidence of chronic scratching, and presence of multiple pruriginous lesions and excoriated nodules.
- •Patient-reported average itching score based on electronic daily diary assessment the last 7 days prior to day 1, at day 1 prerandomization.
- •Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk at initial screening and at day 1 prerandomization.
- •Prior to informed consent, history of inadequate response topical therapies for prurigo nodularis or for whom topical therapies is otherwise medically inadvisable (eg, because of important side effects or safety risks). - Inadequate response is defined as inability to achieve and/or maintain a low disease state despite treatment with a daily regimen of topical therapies, - Participants with any previous systemic treatment or phototherapy for prurigo nodularis or topical Janus kinase (JAK) inhibitors for prurigo nodularis, independent of response, are also considered as inadequate responders and are potentially eligible to be included in the study after appropriate washout.
- •Participants must have completed at least 4 days of daily diary entries within the 7 days preceding and including day 1 prerandomization.
排除标准
- •Skin or systemic morbidities, other than prurigo nodularis, that have been active or requiring treatment within the last 3 months, prior to screening that interfere with the assessment of study outcomes
- •Any of the following laboratory abnormalities at initial screening: - eGFR < 30 mL/min/1.73 m2 - AST or ALT: ≥ 2.5 times the upper limit of normal (ULN) - neutrophil count: < 1.5 x 103/µL
- •Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy.
- •Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within the specified time period before day 1 prerandomization.
- •History of New York Heart Association class III/IV heart failure; diagnosis of uncontrolled hypertension at initial screening; or inadequately treated cardiovascular conditions at initial screening including: cardiomyopathy, major congenital heart disease, or second or third-degree atrioventricular block.
- •Recent cardiovascular events including cerebrovascular accident, myocardial infarction, coronary stenting, or unstable angina within 6 months of day 1 prerandomization
- •Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
- •Positive for HCV antibody at initial screening with confirmed positive HCV RNA.
- •Chronic hepatitis B infection at initial screening, defined as detectable HBsAg or HBV DNA.Participants with detectable anti-HBc and negative HBsAg/HBV DNA are required to do on-study HBV DNA monitoring.
- •Active or latent tuberculosis infection as evident by positive or indeterminate QuantiFERON GOLD from central laboratory at initial screening and assessed at day 1 prerandomization per Screening TB Risk Assessment Questionnaire provided by Amgen.
- •A corrected QT interval (QTc ) of > 450 msec in males of > 470 msec in females at screening as assessed by the investigator, or history of long QT syndrome.
- •History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
- •History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted,would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
- •Prurigo nodularis secondary to medications.
- •Prurigo nodularis secondary to neurologic or psychiatric medical conditions
- •Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
- •Superficial skin infection within 2 weeks before day 1 prerandomization.
- •Known sensitivity to any of the products or components to be administered during dosing.
- •Major psychiatric illness,within 1 year before day 1 prerandomization.
- •Inpatient psychiatric admission within 1 year before day 1 prerandomization.
- •Change in psychiatric medication for a psychiatric illness within 8 weeks before day 1 prerandomization.
- •Anticipated need to change psychiatric medication for a psychiatric illness during the study.
- •History of alcohol or substance abuse within 6 months prior to initial screening.
研究组 & 干预措施
Placebo for AMG 451
Placebo
干预措施: Placebo for AMG 451 (Drug)
Rocatinlimab
Test
干预措施: Rocatinlimab (Drug)
结局指标
主要结局
Achieving reduction from baseline in weekly average of daily itching score at specified time points.
Achieving reduction from baseline in weekly average of daily itching score at specified time points.
次要结局
- Improvement in investigator assessment of PN lesions
- Improvement in daily itching from baseline.
- Improvement in daily skin pain from baseline
- Change in quality of life from baseline.
- Change in sleep disturbance from baseline
- Treatment-emergent adverse events , adverse events of special interest, and serious adverse events
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (68)
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