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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03384641
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Leprosy, Multibacillary Drug: Bedaquiline 200 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Efficacy and Safety of TMC207 in Subjects With Multibacillary Leprosy
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : March 25, 2021
Estimated Study Completion Date : March 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) an average bacteriological index greater than or equal to (>=) 4+ from a six-site skin smear assessment 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

Exclusion Criteria:

  • Has experienced a lepra reaction
  • Has a contraindication limiting the implementation of a medically accepted MB leprosy regimen
  • Has ever received pharmacotherapy for leprosy or is known to have ever received a pharmacotherapy that could be used to treat leprosy (for example, dapsone, clofazimine, rifampicin, moxifloxacin, ofloxacin)
  • Has a concomitant infection that requires an additional systemic antimicrobial agent
  • Has tuberculosis (TB), as determined by medical history and chest x-ray
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384641


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

Locations
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Brazil
Instituto Lauro de Souza Lima Recruiting
Bauru, Brazil, 17034-971
Alfredo da Matta Foundation Recruiting
Manaus, Brazil, 69065-130
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Additional Information:
To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03384641    
Other Study ID Numbers: CR108416
TMC207LEP2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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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
Additional relevant MeSH terms:
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Leprosy
Leprosy, Multibacillary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Bedaquiline
Diarylquinolines
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents