LeprosyPhase 3BE-PEOPLE P3NCT05597280
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
A Phase 3 study testing BE-PEP Bedaquiline, SDR-PEP Rifampicin and BE-PEP Rifampicin in people with Leprosy, run by Institute of Tropical Medicine, Belgium at 1 site in Comoros.
Trial summary
There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- BE-PEP Bedaquiline, SDR-PEP Rifampicin and BE-PEP Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124,000 participants
- Where
- 1 siteComoros
- Study dates
- 22 Mar 2023to 15 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health
- Aged 2 years and above, as leprosy is very rare among infants and young toddlers. Children age 2-4 years or weighing less than 20 kg will not be given bedaquiline. If eligible they will receive only rifampicin.
- Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)
Who cannot join
- Signs of active leprosy
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)
- Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
- Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
- Self-reported (suspected) pregnancy or breastfeeding
- Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natacha Herssens contact
Comoros1 site, 1 recruiting
- Recruiting
Fondation Damien
Moroni
Younoussa Assoumani, yaoussaoumani@gmail.com
About this study
Official title: Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study
There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.
Read the detailed description
Assuming the phase 2 study will not reveal any drug related adverse events and following the advice of the DSMB and the involved ethics committees, the investigators will proceed with a phase 3 study for which randomization will take place in December, 2022. There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms anyone living within 100 meters of an index case will be targeted or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the overall leprosy incidence over the follow-up period will be compared between the two study arms. As stated above, the primary outcome measure will be the incidence rate ratio of leprosy between those who received BE-PEP and those who received the standard SDR-PEP. From this analysis the investigators will exclude those not eligible for BE-PEP, i.e. children below 5 years of age and/or with a weight below 20 kg. A Poisson model will be fit with village nested in island as random effect and controlled for distance to the nearest index case at baseline. In addition the investigators will compute incidence rate ratios between the entire BE-PEP and SDR-PEP arms over the period 2023-2026, also based on a Poisson model with village nested in island as random effect. Throughout the BE-PEOPLE trial the investigators will continue sampling leprosy patients identified (a skin biopsy from the edge of non-facial lesions), with the aim of using molecular assays for M. leprae as quality assurance mechanism. If sufficient DNA is available Deeplex-MycLep will be used for typing the strains, which will allow to perform highly sensitive surveillance for (traces of) resistance to rifampicin and bedaquiline. As part of BE-PEOPLE, the investigators will moreover enroll all microbiologically confirmed tuberculosis patients on all islands of Comoros (Moheli, Anjouan, and Grande Comore, where bedaquiline will not be introduced, maximum 100 patients/ year) and assess whether they ever received (BE-)PEP or leprosy treatment. The investigators will genotype their sputum with Deeplex-MycTB XL, which includes all M. tuberculosis genes (potentially) involved in resistance to rifampicin and bedaquiline, to be able to detect the earliest traces of acquired resistance to these drugs, which is unexpected after single dose administration.The overall goal of BE-PEOPLE is to validate a robust and safe leprosy PEP regimen, and its optimal administration, that prevents leprosy in the individual and interrupts transmission at the village level.If BE-PEP turns out to be safe and successful, the investigators aim to adjust national guidelines in Comoros towards island wide implementation on Anjouan and Moheli, allowing to sustainably eliminate leprosy.
- Conditions
- Leprosy
- Being tested
- BE-PEP Bedaquiline, SDR-PEP Rifampicin, BE-PEP Rifampicin
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BE-PEP BedaquilineDrug
bedaquiline
SDR-PEP RifampicinDrug
SDR-PEP: rifampicin
BE-PEP RifampicinDrug
BE-PEP rifampicin
| Study group | Role | What they receive |
|---|---|---|
| BE-PEP | Experimental | Intervention arm in which BE-PEP will be provided to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts.
BE-PEP: bedaquiline (400 or 800 mg depending on weight band) combined with rifampicin (10 mg/kg) will be provided as post-exposure prophylaxis
Both arms will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg, for bedaquiline it's 20 mg or 100 mg. Receives: Drug: BE-PEP Bedaquiline; Drug: BE-PEP Rifampicin |
| SDR PEP | Active comparator | WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms anyone living within 100 meters of an index case will be targeted or the entire village if more than 50% are eligible.
The dosage form of rifampicine is 150 mg and 300 mg. Receives: Drug: SDR-PEP Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate effectiveness of PEP based on a combination of rifampicin and bedaquiline (BE-PEP), in preventing leprosy among contacts of incident cases.
The incidence rate ratio of leprosy between contacts who received the trial regimen (BE-PEP: rifampicin 600 mg plus bedaquiline 800mg, repeated once after four weeks for household contacts) and those who received the WHO standard prophylactic regimen (SDR-PEP: rifampicin 600 mg, single dose).
Measured: Through study completion, an average of 4 years
Secondary outcomes (6)
To assess effectiveness of the BE-PEP regimen at village level.
The incidence rate ratio between villages that received BE-PEP and villages that received SDR-PEP.
Measured: Through study completion, an average of 4 years
To quantify frequency of potential adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions
The proportion of participants treated with BE-PEP that report adverse events, with a breakdown by type of event.
Measured: Until day 30 after treatment administration. 2026 final analyses
To assess anti-PGL-I sero surveys as a tool to monitor leprosy transmission
anti-PGL-I sero prevalence rates in villages belonging to arm 4 of the original PEOPLE trial at the time of the first survey round in 2019 and the final round of BE-PEOPLE in 2026
Measured: Through study completion, an average of 4 years
To monitor rifampicin and bedaquiline resistance among leprosy and tuberculosis patients
The investigators will quantify the prevalence of rifampicin and/or bedaquiline resistant strains of M. leprae and M. tuberculosis on each of the study islands making use of molecular markers.
Measured: Through study completion, an average of 4 years
To assess cost-effectiveness of the BE-PEP regimen compared to SDR-PEP.
Cost per case averted between BE-PEP arm and SDR-PEP.
Measured: Through study completion, an average of 4 years
To evaluate the viability of Mycobacterium tuberculosis during and after treatment among TB patients on Grande Comore.
The change in viability of Mycobacterium tuberculosis in subsequent samples of TB patient undergoing treatment on Grande Comore
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start22 Mar 2023
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Younoussa Assoumani, Principal investigator, Damien Foundation Comoros
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597280
- Sponsor's protocol ID
- BE-PEOPLE Phase 3
- Acronym
- BE-PEOPLE P3
- Status last verified
- May 2026
- First submitted
- 3 Oct 2022
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Younoussa A, Samidine SN, Bergeman AT, Piubello A, Attoumani N, Grillone SH, Braet SM, Tsoumanis A, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Snijders R, Corstjens P, Ortuno-Gutierrez N, Hoof C, Geluk A, de Jong BC, Hasker E. Protocol, rationale and design of BE-PEOPLE (Bedaquiline enhanced exposure prophylaxis for LEprosy in the Comoros): a cluster randomized trial on effectiveness of rifampicin and bedaquiline as post-exposure prophylaxis of leprosy contacts. BMC Infect Dis. 2023 May 9;23(1):310. doi: 10.1186/s12879-023-08290-0.
PubMed 37161571
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study
- ClinicalTrials.gov ID
- NCT05597280
- Acronym / sponsor ID
- BE-PEOPLE P3 / BE-PEOPLE Phase 3
- Conditions
- Leprosy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124,000 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.
Detailed description
Assuming the phase 2 study will not reveal any drug related adverse events and following the advice of the DSMB and the involved ethics committees, the investigators will proceed with a phase 3 study for which randomization will take place in December, 2022. There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms anyone living within 100 meters of an index case will be targeted or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the overall leprosy incidence over the follow-up period will be compared between the two study arms. As stated above, the primary outcome measure will be the incidence rate ratio of leprosy between those who received BE-PEP and those who received the standard SDR-PEP. From this analysis the investigators will exclude those not eligible for BE-PEP, i.e. children below 5 years of age and/or with a weight below 20 kg. A Poisson model will be fit with village nested in island as random effect and controlled for distance to the nearest index case at baseline. In addition the investigators will compute incidence rate ratios between the entire BE-PEP and SDR-PEP arms over the period 2023-2026, also based on a Poisson model with village nested in island as random effect. Throughout the BE-PEOPLE trial the investigators will continue sampling leprosy patients identified (a skin biopsy from the edge of non-facial lesions), with the aim of using molecular assays for M. leprae as quality assurance mechanism. If sufficient DNA is available Deeplex-MycLep will be used for typing the strains, which will allow to perform highly sensitive surveillance for (traces of) resistance to rifampicin and bedaquiline. As part of BE-PEOPLE, the investigators will moreover enroll all microbiologically confirmed tuberculosis patients on all islands of Comoros (Moheli, Anjouan, and Grande Comore, where bedaquiline will not be introduced, maximum 100 patients/ year) and assess whether they ever received (BE-)PEP or leprosy treatment. The investigators will genotype their sputum with Deeplex-MycTB XL, which includes all M. tuberculosis genes (potentially) involved in resistance to rifampicin and bedaquiline, to be able to detect the earliest traces of acquired resistance to these drugs, which is unexpected after single dose administration.The overall goal of BE-PEOPLE is to validate a robust and safe leprosy PEP regimen, and its optimal administration, that prevents leprosy in the individual and interrupts transmission at the village level.If BE-PEP turns out to be safe and successful, the investigators aim to adjust national guidelines in Comoros towards island wide implementation on Anjouan and Moheli, allowing to sustainably eliminate leprosy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BE-PEP | Experimental | Drug: BE-PEP Bedaquiline, Drug: BE-PEP RifampicinIntervention arm in which BE-PEP will be provided to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. BE-PEP: bedaquiline (400 or 800 mg depending on weight band) combined with rifampicin (10 mg/kg) will be provided as post-exposure prophylaxis Both arms will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg, for bedaquiline it's 20 mg or 100 mg. |
| SDR PEP | Active comparator | Drug: SDR-PEP RifampicinWHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms anyone living within 100 meters of an index case will be targeted or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health
- Aged 2 years and above, as leprosy is very rare among infants and young toddlers. Children age 2-4 years or weighing less than 20 kg will not be given bedaquiline. If eligible they will receive only rifampicin.
- Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)
Key exclusion criteria (6 listed)
- Signs of active leprosy
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)
- Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
- Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
- Self-reported (suspected) pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BE-PEP Bedaquilinebedaquiline | Drug | BE-PEP |
| SDR-PEP RifampicinSDR-PEP: rifampicin | Drug | SDR PEP |
| BE-PEP RifampicinBE-PEP rifampicin | Drug | BE-PEP |
Primary outcome
To evaluate effectiveness of PEP based on a combination of rifampicin and bedaquiline (BE-PEP), in preventing leprosy among contacts of incident cases.
Time frame: Through study completion, an average of 4 years
The incidence rate ratio of leprosy between contacts who received the trial regimen (BE-PEP: rifampicin 600 mg plus bedaquiline 800mg, repeated once after four weeks for household contacts) and those who received the WHO standard prophylactic regimen (SDR-PEP: rifampicin 600 mg, single dose).
6 secondary outcomes
To assess effectiveness of the BE-PEP regimen at village level.
Time frame: Through study completion, an average of 4 years
To quantify frequency of potential adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions
Time frame: Until day 30 after treatment administration. 2026 final analyses
To assess anti-PGL-I sero surveys as a tool to monitor leprosy transmission
Time frame: Through study completion, an average of 4 years
To monitor rifampicin and bedaquiline resistance among leprosy and tuberculosis patients
Time frame: Through study completion, an average of 4 years
To assess cost-effectiveness of the BE-PEP regimen compared to SDR-PEP.
Time frame: Through study completion, an average of 4 years
To evaluate the viability of Mycobacterium tuberculosis during and after treatment among TB patients on Grande Comore.
Time frame: Through study completion, an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 37161571Younoussa A, Samidine SN, Bergeman AT, Piubello A, Attoumani N, Grillone SH, Braet SM, Tsoumanis A, Baco A, Mzembaba A, Salim Z, Amidy M, Grillone S, Snijders R, Corstjens P, Ortuno-Gutierrez N, Hoof C, Geluk A, de Jong BC, Hasker E. Protocol, rationale and design of BE-PEOPLE (Bedaquiline enhanced exposure prophylaxis for LEprosy in the Comoros): a cluster randomized trial on effectiveness of rifampicin and bedaquiline as post-exposure prophylaxis of leprosy contacts. BMC Infect Dis. 2023 May 9;23(1):310. doi: 10.1186/s12879-023-08290-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natacha Herssens contact
Younoussa Assoumani principal investigator
Damien Foundation Comoros
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BE-PEP Bedaquiline, SDR-PEP Rifampicin and BE-PEP Rifampicin in people with Leprosy, run by Institute of Tropical Medicine, Belgium at 1 site in Comoros.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Comoros. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolien Hoof (+32(0)32470716, choof@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate effectiveness of PEP based on a combination of rifampicin and bedaquiline (BE-PEP), in preventing leprosy among contacts of incident cases. (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.