Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)
NCT07918573, Phase 2, Not yet recruiting, Fondation Raoul Follereau
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial) | ClinicalTrials.gov |
| NCT number | NCT07918573 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondation Raoul Follereau | ClinicalTrials.gov |
| Conditions | Leprosy, Multibacillary | ClinicalTrials.gov |
| Interventions | Telacebec 300 mg, Telacebec 600 mg, Telacebec + Rifampicine | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in viable Mycobacterium leprae load in participants' skin lesions | Baseline (Day 0) and Day 84 | Treatment response of leprosy infection in each participant, measured in skin biopsies taken from the same lesion at baseline and Day 84 using the Molecular Viability Assay (MVA): quantitative RT-PCR of esxA and hsp18 transcripts, standardised to 3,000 bacilli. Reported as change in log10 viability; a larger decrease indicates a greater bactericidal effect of treatment in the participant. Arms B, C and D are compared with standard WHO MB-MDT (Arm A) | ClinicalTrials.gov |
| Secondary | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | From first dose through Day 84 (end of study drug period) | Clinical and laboratory adverse events, graded for severity and assessed for relationship to study drug, in participants receiving telacebec 300 mg, telacebec 600 mg, telacebec 300 mg + rifampicin 600 mg, or WHO MB-MDT | ClinicalTrials.gov |
| Secondary | Proportion of participants with clinical improvement of leprosy skin lesions | Day 84 and Month 12 (end of treatment) | Assessed with standardised lesion-response criteria based on clinical examination and standardised photographs, classified as clear, moderate or no improvement. Classification validated by an independent external expert panel. | ClinicalTrials.gov |
| Secondary | Incidence and severity of leprosy reactions | Baseline through Month 24 (end of follow-up) | Number of participants with Type 1 (reversal) reactions, defined by WHO criteria, and Type 2 reactions (erythema nodosum leprosum). ENL severity scored with the ENLIST ENL Severity Scale (EESS). | ClinicalTrials.gov |
| Secondary | Change in peripheral nerve sensory function | Baseline, Day 84, Month 12, Month 24 | Semmes-Weinstein monofilament thresholds at standardised sites of the hands and feet. | ClinicalTrials.gov |
| Secondary | Change in peripheral nerve motor function | Baseline, Day 84, Month 12, Month 24 | Voluntary Muscle Testing (VMT) scores. | ClinicalTrials.gov |
| Secondary | Number of participants with new nerve function impairment | Baseline through Month 24 | ClinicalTrials.gov | |
| Secondary | Change in health-related quality of life (EQ-5D) | Baseline, Day 84, Month 12 | ClinicalTrials.gov | |
| Other | Participant-reported global impression of change (PGI-C) | Day 84, Month 12 | ClinicalTrials.gov | |
| Other | Proportion of participants with viable M. leprae in skin lesions | Baseline and Day 84 | Skin biopsy material from a subset of participants (5 to 6 per group) are tested: Data reported per participant (presence of viable bacilli on day 84 compared to that participant's baseline sample). | ClinicalTrials.gov |
| Other | Change from baseline in M. leprae rRNA synthesis (RS) ratio in participants' skin lesions | Baseline and Day 84 | Marker of ongoing bacterial replication in each participant's lesion | ClinicalTrials.gov |
| Other | Number of participants who discontinue or interrupt study treatment because of adverse events | Throught Day 84 | ClinicalTrials.gov | |
| Other | Number of participants with treatment-emergent laboratory abnormalities | Throught Day 84 | Haematology, biochemistry and liver function tests | ClinicalTrials.gov |
| Other | Plasma concentration of telacebec in participants | Day 0 through Day 84 | Sparse pharmacokinetic sampling | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)