Health Condition 1: A30- Leprosy [Hansens disease]
Conditions
Interventions
Intervention1: Arm A: Bedaquiline-containing Multiple-drug
Therapy (MDT): bedaquiline 200 mg qd for 14 days (intensive phase)
followed by bedaquiline 800 mg q4w from Day 28 (5 intakes) in combination
Sponsors
Janssen Pharmaceutica NV
Eligibility
Inclusion criteria
Inclusion criteria: 1. Fifteen years and older, on the day of signing the ICF/assent. 2. Has presence of AFB in any SSS taken at screening from a skin lesion from which a biopsy can be taken. 3. 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. OR at least 1 confluent skin lesion, consistent with MB leprosy, which measures at least 8 cm in diameter. 4. Human immunodeficiency virus-infected participants are allowed if the participant: a. Has a documented HIV-positive status prior to screening. b. Started antiretroviral therapy at least 12 weeks before baseline. c. Is on, or switches to, an ART regimen not containing efavirenz at least 4 weeks prior to enrollment. d. Has a CD4+ cell count =200 cells/µL. e. 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. 5. Has a body weight =30 kg
Exclusion criteria
Exclusion criteria: 1. Has the clinical characteristics of leprosy but presenting only with diffuse infiltration without specific lesions. 2. Has active tuberculosis, ongoing leishmaniasis or Chagas disease, or active hepatitis B or hepatitis C. 3. Has a history of or current non-leprosy-related neuropathies that would affect the interpretation of data collected in the nerve function clinical testing. 4. Has any skin disorder that, in the opinion of the investigator, might interfere with the assessment of leprosy skin lesions. 5. 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Screening period, Day 1, Weeks 12, 24, 36, 52, 64, 76, 88, 100 | — |
Primary
| Measure | Time frame |
|---|---|
| Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded, independent AC using a standardized skin assessmentTimepoint: At Baseline and 52 weeks after start of treatment | — |
Countries
Brazil, India
Contacts
Public ContactDr Sanish Davis
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
Outcome results
None listed