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

• ClinicalTrials.gov Identifier: NCT03384641
• Recruitment Status: Recruiting
• First Posted: December 27, 2017
• Last Update Posted: February 17, 2021
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: December 20, 2017
• First Posted Date: December 27, 2017
• Last Update Posted Date: February 17, 2021
• Actual Study Start Date: September 26, 2018
• Estimated Primary Completion Date: October 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2018)

Change from Baseline in the Odds of Mycobacterium leprae (M. leprae) Growth in Mouse Footpads Following 8 Weeks of Treatment with Bedaquiline [ Time Frame: Baseline up to Week 8 ]

Change from baseline in the odds of M. leprae growth in mouse footpads will be evaluated. M. leprae bacilli will be inoculated in footpads of mice, according to the method of Shepard. M. leprae growth will be determined by technologists trained and experienced in mouse footpad procedures, at 1 year after infection (or at mouse death or humane endpoint, if it occurs greater than or equal to [>=] 6 months after footpad inoculation). The number of footpads with positive growth (>=10^5 M. leprae) will be counted and used to determine the odds of bacterial growth.

Original Primary Outcome Measures (submitted: December 20, 2017)

Change from Baseline in the Odds of Mycobacterium leprae (M. leprae) Growth in Mouse Footpads Following 8 Weeks of Treatment with Bedaquiline [ Time Frame: Baseline up to Week 8 ]

Change from baseline in the odds of M. leprae growth in mouse footpads will be evaluated. M. leprae bacilli will be inoculated in footpads of mice, according to the method of Shephard. M. leprae growth will be determined by technologists trained and experienced in mouse footpad procedures. The number of footpads with positive growth (greater than or equal to (>=) 10^5 M. leprae) will be counted and used to determine the odds of bacterial growth.

Current Secondary Outcome Measures (submitted: December 20, 2017)

• Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 124 Weeks ]
  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
• Number of Participants with AEs by Severity [ Time Frame: Up to 124 Weeks ]
  Severity of adverse events will be graded by using division of microbiology and infectious diseases (DMID) adult toxicity scale to estimate grade of severity. Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, and Grade 4= Life-threatening.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy
• Official Title: An Open-Label Study to Evaluate the Efficacy and Safety of TMC207 in Subjects With Multibacillary Leprosy
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Leprosy, Multibacillary

Intervention

Drug: 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.

Other Name: TMC207

Study Arms

Experimental: 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.

Intervention: Drug: Bedaquiline 200 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 20, 2017): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 29, 2022
• Estimated Primary Completion Date: October 15, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Study Contact; 844-434-4210; JNJ.CT@sylogent.com

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT03384641
• Other Study ID Numbers: CR108416; TMC207LEP2001 ( Other Identifier: Janssen Research & Development, LLC )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Janssen Research & Development, LLC
• Study Sponsor: Janssen Research & Development, LLC
• Collaborators: Not Provided

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

• PRS Account: Janssen Research & Development, LLC
• Verification Date: February 2021