A Randomized, Double-blind, Placebo-controlled, Phase 2, 12-Week Treatment Study With a 10-Week Follow-up Period to Assess the Efficacy and Safety of Benralizumab (Anti-IL5Rα) in Adult Patients With Chronic Prurigo
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Numerical rating scale of the worst itch (WI-NRS)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, Phase 2, 12-Week treatment study with a 10-Week Follow-up period to assess the efficacy and safety of Benralizumab (anti-IL5Rα) in adult patients with chronic prurigo (BICPIC)
详细描述
Chronic Prurigo (CPG) is a skin disease of unknown incidence and prevalence that can occur in all age groups including children, but which is most prevalent in elderly people. CPG was defined as a distinct disease in 2018 by the Task Force Pruritus of the EADV and diagnosis is based on the presence of chronic pruritus, multiple localized or generalized, pruriginous lesions, and the history and/or signs of a prolonged scratching behavior. While CPG is a disease in its own right, the initial causes of chronic pruritus can be manifold and may be of dermatological, systemic, neurological, psychiatric/psychosomatic, multifactorial or of unknown origin. The pruriginous lesions can be skin-colored, pink or red, hyperkeratotic or excoriated, scaling and/or crusted papules and/or nodules and/or plaques. Depending on the predominant clinical phenotype, CPG subtypes have been defined as papular type, nodular type (also called prurigo nodularis), plaque type, umbilicated type or linear prurigo. Of these, the nodular type is the most frequent one. Although CPG patients are sometimes covered in excoriated intensely pruritic nodules, these skin lesions are always secondary to an intense itch-scratch cycle. Thus, an effective treatment of itch will also lead to the disappearance of the skin lesions. The vast majority of CPG patients are resistant to common therapy and desperate for novel treatment options. Consequently, those affected by intensely itchy CPG are dramatically impaired in their quality of life. Currently, there are no approved therapies for the treatment of CPG available.
The study aims to assess the exploratory efficacy and safety of benralizumab, a monoclonal antibody against IL5Rα in adult patients with chronic prurigo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is informed about study procedures and medications and has given written informed consent before any assessment.
- •Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
- •Clinical diagnosis of CPG for at least 6 months with:
- •Severe pruritus with WI-NRS rating ≥ 6 (Mean of the worst daily intensity over the previous 3 days at Screening and over the previous week at baseline [minimum of at least 5 days during the week preceding the baseline visit]).
- •Pruriginous nodular, papular, plaque and/or umbilicated lesions on upper limbs, trunk, and/or lower limbs
- •At least 20 CPG lesions on the entire body with a bilateral distribution
- •Willing and able to complete a daily symptom Diary for the duration of the study and adhere to the study visit schedules.
- •Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control
- •Negative COVID-19 test
排除标准
- •Chronic pruritus resulting from another active condition other than CPG
- •Unilateral lesions of prurigo (eg, only one arm affected)
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •Patients who previously received benralizumab
- •Patients with hypersensitivity to any of the excipients of the IMP or history of anaphylaxis to any biologic therapy or vaccine.
- •Any disorder that is not stable in the opinion of the Investigator and could: (a) Affect the safety of the participant throughout the study, (b) Influence the findings of the studies or their interpretations, (c) Impede the participant's ability to complete the entire duration of study.
- •Inability to comply with study and follow-up procedures.
- •Current malignancy, or history of malignancy within the last 5 years
- •Current active liver disease
- •A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
- •Subjects who live in detention on court order or on regulatory action as per local and national law (see §40 subsection 1 sentence 3 no. 4 Arzneimittelgesetz)
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •Patients with active COVID-19 infection. Patients with symptoms consistent with COVID-19 infection should be tested prior to enrollment.
研究组 & 干预措施
Benralizumab
Fasenra 60mg s.c. administration
干预措施: Fasenra Prefilled Syringe (Drug)
Placebo
Placebo s.c. administration
干预措施: Matching Placebo Solution (Other)
结局指标
主要结局
Numerical rating scale of the worst itch (WI-NRS)
时间窗: Week 0 to week 12
Percent change from baseline in numerical rating scale of the worst itch
次要结局
- Effects on responder rates(12 weeks)
- Investigator Global Assessment (IGA)-stage(12 weeks)
- Change in the patient's quality of life(12 weeks)
- Prurigo Activity Score (PAS)(12 weeks)
- Investigator Global Assessment (IGA)(12 weeks)
- Pruritus WI-NRS(12 weeks)
- Prurigo Control Test (PCT)(12 weeks)
- Numerical rating scale (NRS) of sleep disturbance(12 weeks)
研究者
Martin Metz
Prof.
Charite University, Berlin, Germany