Multibacillary Leprosy MedDRA version: 20.0 Level: LLT Classification code 10024232 Term: Leprosy, unspecified System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Bedaquiline
Pharmaceutical Form: Tablet
INN or Proposed INN: Bedaquiline
Other descriptive name: BDQ
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
Janssen Pharmaceutica NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. Fifteen years and older, on the day of signing the ICF/assent. 2. Has presence of acid-fast bacilli in any slit-skin smear 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 6. A female participant of childbearing potential must have a negative highly sensitive pregnancy test at screening and on Day 1 before randomization. 7. A female participant must be a. Not of childbearing potential b. Of childbearing potential and adhering to the recommendations as specified in the protocol Are the trial subjects under 18? yes Number of subjects for this age range: 19 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 199 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Has the clinical characteristics of leprosy but presenting only with diffuse infiltration without specific lesions, or with only hypochromic/hypopigmented macules. 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. 6. Has any of the following cardiac risk factors during the screening period: - Clinical signs of heart failure. - QTcF interval >450 ms (confirmed by repeat ECG). - A personal or family history of congenital QT interval prolongation (long QT syndrome). - A history of or ongoing inadequately treated or untreated hypothyroidism. - A history of or ongoing bradyarrhythmia (HR <50 bpm). - A history of Torsade de Pointes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of the 24-week bedaquiline-containing multidrug therapy (bedaquiline with rifampicin and clofazimine) for the treatment of multibacillary leprosy compared to the 48-week WHO standard of care (rifampicin, clofazimine, and dapsone) at 48 weeks after start of treatment as rated by the blinded, independent Adjudication Committee.;Secondary Objective: To evaluate the efficacy of a 24-week bedaquiline-containing multidrug therapy for the treatment of multibacillary leprosy compared to the 48-week WHO standard of care multidrug therapy at 48 weeks after start of treatment as rated by the blinded onsite clinical rater.;Primary end point(s): Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded, independent AC using a standardized skin assessment;Timepoint(s) of evaluation of this end point: 52 weeks after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded onsite clinical rater using a standardized skin assessment;Timepoint(s) of evaluation of this end point: 52 weeks after start of treatment | — |
Countries
Brazil, India
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed