CTRI/2025/02/079888 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On:
21/07/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Efficacy and safety study of Bedaquiline in MB Leprosy.
Scientific Title of Study
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
Trial Acronym
LIGHT
Secondary IDs if Any
Secondary ID
Identifier
2021-006613-10
EudraCT
TMC207LEP3001, Version No. Original dated 09-NOV-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sanish Davis
Designation
Director Research and Development GCO India
Affiliation
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
Address
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. Johnson and Johnson Private Limited, Arena Space Jogeshwari East.
Mumbai
MAHARASHTRA
400060
India Johnson and Johnson Private Limited, Arena Space, JVLR, Behind Majas Depot, Jogeshwari East.
Mumbai
MAHARASHTRA
400060
India Mumbai MAHARASHTRA 400060 India
Phone
919820958943
Fax
Email
sdavis20@its.jnj.com
Details of Contact Person Scientific Query
Name
Dr Sanish Davis
Designation
Director Research and Development GCO India
Affiliation
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
Address
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. Johnson and Johnson Private Limited, Arena Space Jogeshwari East.
Mumbai
MAHARASHTRA
400060
India Johnson and Johnson Private Limited, Arena Space, JVLR, Behind Majas Depot, Jogeshwari East.
Mumbai
MAHARASHTRA
400060
India Mumbai MAHARASHTRA 400060 India
Phone
919820958943
Fax
Email
sdavis20@its.jnj.com
Details of Contact Person Public Query
Name
Dr Sanish Davis
Designation
Director Research and Development GCO India
Affiliation
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
Address
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. Johnson and Johnson Private Limited, Arena Space Jogeshwari East.
Mumbai
MAHARASHTRA
400060
India Johnson and Johnson Private Limited, Arena Space, JVLR, Behind Majas Depot, Jogeshwari East.
Mumbai
MAHARASHTRA
400060
India Mumbai MAHARASHTRA 400060 India
Phone
919820958943
Fax
Email
sdavis20@its.jnj.com
Source of Monetary or Material Support
Johnson & Johnson Private Limited, LBS Marg, Mulund West Mumbai 400080 Address
For correspondence: Arena Space, Behind Majas Bus Depot, Off J.V. Link Road, Jogeshwari
(E),Mumbai - 400060
Primary Sponsor
Name
Janssen Pharmaceutica NV
Address
Johnson and Johnson Pvt. Ltd., 501 Arena space, Behind Majas Bus
Depot, off J.V. Link Road, Jogeshwari East, Mumbai 400060
Maharashtra
Department of Dermatology; 578, B.T. Road, Kamarhati, Kolkata-700058, West Bengal, India Kolkata WEST BENGAL
9433394148
drdasnilay@gmail.com
Dr Ayush Gupta
Dr. D. Y. Patil Medical College, Hospital & Research Centre
OPD No 8, Department of Dermatology, Ground Floor, Sant Tukaram Nagar, Pimpri, Pune 411018 Maharashtra, India. Pune MAHARASHTRA
9545711211
aayush.gupta@dpu.edu.in
Dr Jacintha Martis
Father Muller Medical College Hospital
Skin OPD, Room No. 65, Department of Dermatology, Father Muller Medical College Hospital, Father Mullers Rd, Kankanady, Mangaluru, Karnataka 575002
Dakshina Kannada KARNATAKA
8242436301
jacimartis18@gmail.com
Dr Sushil Pande
NKP Salve Institute of Medical Sciences
Department of Dermatology, OPD No.04 1st Floor, Superspeciality building, NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital, Digdoh Hillas, Hingna Road Nagpur 440019 Nagpur MAHARASHTRA
7122289955
drsushilpande@gmail.com
Dr Sunil Dogra
Postgraduate Institute of Medical Education & Research (PGIMER)
Room No 5006, 5th Level Department of Dermatology New OPD Block, Postgraduate Institute of Medical Education and Research Sector-12, Chandigarh 160012 Chandigarh CHANDIGARH
9855005941
sundogra@hotmail.com
Dr Ilse Horo
SCHIEFFELIN INSTITUTE OF HEALTH – RESEARCH & LEPROSY CENTRE, KARIGIRI
KARIGIRI, Vellore, Tamil Nadu 632106 Vellore TAMIL NADU
6382719348
ilse.horo@karigiri.org
Dr Vikrant Saoji
Viveka Hospitals
5th floor,Room number 542 , Plot no 1A,Naik Layout, Subhash Nagar- Nagpur Maharashtra 440022,
Nagpur MAHARASHTRA
Arm A: Bedaquiline-containing Multiple-drug
Therapy (MDT)
bedaquiline 200 mg qd for 14 days (intensive phase)
followed by bedaquiline 800 mg q4w from Day 28 (5 intakes) in combination with RMP
600 mg q4w (6 intakes, starting at Day 1) + CFZ 300 mg q4w (6 intakes, starting at Day 1)
and CFZ 50 mg qd for a total duration of 24 weeks.
Comparator Agent
Arm B: World Health Organization (WHO) Standard of Care (SOC) MDT
RMP 600 mg q4w (12 intakes) + CFZ 300 mg q4w (12 intakes)
and CFZ 50 mg qd + DDS 100 mg qd (all starting at Day 1) for a total duration of 48 weeks.
1 tablet of Dapsone (100 Mg)
Once a day - Days 2 - 28
1 Capsule1 of Clofazimine (50 mg)
1 tablet of Dapsone (100 Mg)
Inclusion Criteria
Age From
15.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Fifteen years and older, on the day of signing the ICF/assent.
2. Has presence of AFB in any SSS 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
ExclusionCriteria
Details
1. Has the clinical characteristics of leprosy but presenting only with
diffuse infiltration without specific lesions.
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the
blinded, independent AC using a standardized skin assessment
At Baseline and 52 weeks after start of treatment
Secondary Outcome
Outcome
TimePoints
Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded onsite clinical rater using a standardized skin
assessment, at 52 weeks after start of treatment.
Total Sample Size="262" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
18/03/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
10/01/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="8" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a multicenter, randomized, open-label, rater-blind, active-controlled, interventional Phase 3 study in male and female participants aged 15 years or older and newly diagnosed with MB leprosy.
This study aims to demonstrate if the efficacy of the 24-week bedaquiline-containing MDT regimen is non-inferior to that of the 48-week WHO SOC MDT in participants with MB leprosy.
Primary Objective -
To demonstrate the efficacy of the 24-week bedaquiline-containing MDT (bedaquiline with RMP and CFZ) for the treatment of MB leprosy compared to the 48-week WHO SOC MDT (RMP, CFZ, and DDS) at 52 weeks after start of treatment as rated by the blinded, independent Adjudication Committee (AC).
Primary Outcome -
Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded, independent AC using a standardized skin assessment, at 52 weeks after start of treatment.
Key Secondary Objective -
To evaluate the efficacy of a 24-week bedaquiline-containing MDT for the treatment of MB leprosy compared to the 48-week WHO SOC MDT at 52 weeks after start of treatment as rated by the blinded onsite clinical rater.
Key Secondary Outcome -
Favorable clinical response based on improvement of leprosy skin characteristics, as determined by the blinded onsite clinical rater using a standardized skin assessment, at 52 weeks after start of treatment.