A Phase 3, Multicenter, Open-label, Rater-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline for the Treatment of Multibacillary Leprosy When Combined With Rifampicin and Clofazimine
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 262
- 试验地点
- 11
- 主要终点
- Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the
研究概览
简要总结
This is a multicenter, randomized, open-label, rater-blind, active-controlled, interventional Phase 3 study in male and female participants aged 15 years or older and newly diagnosed with MB leprosy.
This study aims to demonstrate if the efficacy of the 24-week bedaquiline-containing MDT regimen is non-inferior to that of the 48-week WHO SOC MDT in participants with MB leprosy.
Primary Objective -
To demonstrate the efficacy of the 24-week bedaquiline-containing MDT (bedaquiline with RMP and CFZ) for the treatment of MB leprosy compared to the 48-week WHO SOC MDT (RMP, CFZ, and DDS) at 52 weeks after start of treatment as rated by the blinded, independent Adjudication Committee (AC).
Primary Outcome -
Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded, independent AC using a standardized skin assessment, at 52 weeks after start of treatment.
Key Secondary Objective -
To evaluate the efficacy of a 24-week bedaquiline-containing MDT for the treatment of MB leprosy compared to the 48-week WHO SOC MDT at 52 weeks after start of treatment as rated by the blinded onsite clinical rater.
Key Secondary Outcome -
Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded onsite clinical rater using a standardized skin assessment, at 52 weeks after start of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Fifteen years and older, on the day of signing the ICF/assent.
- •Has presence of AFB in any SSS taken at screening from a skin lesion from which a biopsy can be taken.
- •Has at least 3 skin lesions, consistent with MB leprosy, of which 2 measure at least 5 cm in diameter.
- •OR at least 10 nodules/lepromas, consistent with MB leprosy, of which 2 measure at least 0.5 cm in diameter.
- •Human immunodeficiency virus-infected participants are allowed if the participant: a.
- •Has a documented HIV-positive status prior to screening.
- •Started antiretroviral therapy at least 12 weeks before baseline.
- •Is on, or switches to, an ART regimen not containing efavirenz at least 4 weeks prior to enrollment.
- •Has a CD4+ cell count ≥200 cells/μL.
- •Has no acquired immunodeficiency syndrome (AIDS)-defining illness or did not show severe symptoms of HIV infection that would make the participant a poor candidate for participation in the study.
- •Has a body weight ≥30 kg.
排除标准
- •Has the clinical characteristics of leprosy but presenting only with diffuse infiltration without specific lesions.
- •Has active tuberculosis, ongoing leishmaniasis or Chagas disease, or active hepatitis B or hepatitis C.
- •Has a history of or current non-leprosy-related neuropathies that would affect the interpretation of data collected in the nerve function clinical testing.
- •Has any skin disorder that, in the opinion of the investigator, might interfere with the assessment of leprosy skin lesions.
- •Has a relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism, or excretion such as malabsorption syndrome or renal or hepatic disease.
结局指标
主要结局
Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the
时间窗: At Baseline and 52 weeks after start of treatment
blinded, independent AC using a standardized skin assessment
时间窗: At Baseline and 52 weeks after start of treatment
次要结局
- Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded onsite clinical rater using a standardized skin(assessment, at 52 weeks after start of treatment.)
研究者
Dr Sanish Davis
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.