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

Phase 1

• Conditions: Multibacillary Leprosy; MedDRA version: 20.0Level: LLTClassification code 10024232Term: Leprosy, unspecifiedSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-006613-10-Outside-EU/EEA
• Lead Sponsor: Janssen Pharmaceutica NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified