A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy

NCT ID: NCT03384641

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2024-01-09

Brief Summary

The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy regimen in participants with treatment-naive, multibacillary (MB) leprosy.

Conditions

Leprosy, Multibacillary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bedaquiline

Participants will receive bedaquiline 200 (milligram) mg (2\*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet three times a week (tiw) for 6 weeks with at least 48 hours between doses.

Group Type: EXPERIMENTAL

Bedaquiline 200 mg

Intervention Type: DRUG

Participants will receive bedaquiline 200 mg (2\*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet tiw for 6 weeks with at least 48 hours between doses.

Interventions

Bedaquiline 200 mg

Participants will receive bedaquiline 200 mg (2\*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet tiw for 6 weeks with at least 48 hours between doses.

Intervention Type: DRUG

Other Intervention Names

TMC207

Eligibility Criteria

Inclusion Criteria

• Participant has: a) multibacillary (MB) leprosy, defined as 6 or more skin lesions or extensive confluent lesions or diffuse skin involvement, and is either borderline lepromatous or polar lepromatous, as determined using Ridley and Jopling classification system; and b) has a bacteriological index of >=4+ from the lesion biopsy obtained at screening, and a bacteriological index of >= 1+ from each of 4 slit skin smear assessments taken at screening
• Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
• Otherwise healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• a man must agree not to donate sperm throughout treatment with TMC207 and for 3 months after treatment is stopped
• Willing and able to adhere to the prohibitions, restrictions, and long-term follow up requirements specified in this protocol
• If a woman is of childbearing potential, must be practising a highly effective method of birth control (failure rate of <1% per year when used consistently and correctly) before entry, and must also agree to use a barrier contraceptive method (that is, male or female condom, diaphragm or cervical cap) plus spermicide. participant must also agree to continue to use a highly effective method of contraception plus a barrier method throughout treatment with TMC207 and until 6 months after treatment is stopped

Exclusion Criteria

• Has experienced or is experiencing a lepra reaction requiring treatment with a prohibited therapy
• Has a contraindication limiting the implementation of a medically accepted MB leprosy regimen
• a) Has ever received pharmacotherapy for leprosy; b) has ever been treated with a drug that is a component of the primary World Health Organization (WHO) regimen for the treatment of MB leprosy (example, dapsone, rifampicin, clofazimine). Short-term (<=2 weeks) pharmacotherapy with any antibiotic that could be used as a second line treatment for leprosy (eg, of the macrolide, quinolone, or tetracycline class) is acceptable as long as the last administration occurred >=4 weeks before first dose of study drug (TMC207)
• Has a concomitant infection that requires an additional systemic antimicrobial agent
• Has tuberculosis (TB), as determined by medical history and chest x-ray
• Is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Instituto Lauro de Souza Lima

Bauru, , Brazil

Fundacao Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta - FUHAM

Manaus, , Brazil

Countries

Brazil

References

Barreto J, Sammarco Rosa P, Adams L, Aguilar Z, Bakare N, Chaplan SR, Akli RD, Ernault E, Kulke S, Lounis N, Millington D, Palmer JA, Remmerie B, Wang M, Young S, Truman R, Rebello PFB. Bedaquiline Monotherapy for Multibacillary Leprosy. N Engl J Med. 2024 Dec 12;391(23):2212-2218. doi: 10.1056/NEJMoa2312928.

Reference Type: DERIVED

PMID: 39665652 (View on PubMed)

Other Identifiers

TMC207LEP2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108416

Identifier Type: -

Identifier Source: org_study_id