NCT03532958撤回2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Intravenous BNZ-1 in Patients With Moderate to Severe Alopecia Areata
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Equillium
- 主要终点
- Change from baseline using the Severity of Alopecia Tool (SALT) score
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to characterize the efficacy and safety of BNZ-1 administered by slow IV push weekly for 3 months to adults diagnosed with moderate to severe alopecia areata, defined as having a >50% loss of terminal hair on the scalp. The study has three periods:
- 30-Day Screening Period
- 3-Month Treatment Period
- 3-Month Follow-up Period The study will be conducted at approximately 15-20 clinical sites in the United States.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must have a diagnosis of moderate to severe AA defined as the presence of ≥50% total terminal hair loss at baseline as measured using the SALT score for > 6 months, but <10 yrs. Includes Alopecia Totalis and Alopecia Universalis
- •Patients may be naïve to treatment or have been treated with intralesional (IL) steroids or other treatments for AA, with a washout of at least 30 days or 5 times the elimination half-life prior to Day
- •Prior treatment with a janus kinase (JAK) inhibitor (e.g., tofacitinib, ruxolitnib) is allowed, but patients considered refractory to a JAK inhibitor are excluded from this trial.
排除标准
- •e subjects from this study if any of the following criteria are met:
- •Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator. Other active dermatologic conditions, including but not limited to vitiligo, atopic dermatitis, or non-scalp psoriasis are not exclusionary.
- •Patients with active inflammatory skin disease on the scalp, including but not limited to psoriasis, seborrheic dermatitis or folliculitis, which cannot be adequately controlled prior to screening.
- •Ongoing treatment with an immune system modulator or suppressant that cannot be discontinued prior to screening and at least 30 days or 5-times the elimination half-life prior to treatment.
- •Any ongoing topical treatment for alopecia areata
- •History of or currently active primary or secondary immunodeficiency.
- •Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including latent tuberculosis [TB] unless treatment is documented or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 60 days of study drug administration or oral antibiotics within 30 days prior to study drug administration.
- •Received other investigational products or therapy in the 60 days prior to study drug administration.
研究组 & 干预措施
Moderate Dose BNZ-1
Experimental
2 mg/kg QW
干预措施: BNZ-1 (Drug)
Placebo
Placebo Comparator
Normal saline
干预措施: Normal saline (Drug)
Low Dose BNZ-1
Experimental
0.5 mg/kg QW
干预措施: BNZ-1 (Drug)
结局指标
主要结局
Change from baseline using the Severity of Alopecia Tool (SALT) score
时间窗: 3 months
Treatment-Emergent Adverse Events
时间窗: 3 months
Safety profile defined as incidence, severity and relationship of treatment-emergent adverse events
次要结局
- Proportion of Patients with SALT100 (Disease-free)(3 months & 6 months)
- Change from Baseline on Alopecia Areata Symptom Impact Scale (AASIS)(3 months)
- Alopecia Areata Investigator Global Assessment (AA-IGA)(3 & 6 months)
- Proportion of Patients with SALT75(3 months & 6 months)
- Proportion of Patients with SALT90(3 months & 6 months)
- Patient Global Assessment(3 & 6 months)
- Proportion of Patients with SALT50(3 months & 6 months)
- Change from Baseline on Dermatology Life Quality Index (DLQI)(3 months)
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