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Not Yet Recruiting NCT07918573

Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)

Conditions: Leprosy, Multibacillary

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Fondation Raoul Follereau

Location: Centre de Dépistage et de Traitement de la Lèpre et de l'Ulcère de Buruli (Raoul et Madeline Follereau) de Pobè Pobé Pobé

Summary

The goal of this clinical trail is to evaluate whether short-course telacebec-based regimens can induce rapid and measurable reductions in M. leprae viability, potentially establishing the foundation for future shorter, safer, and simplified therapeutic strategies for MB leprosy. Participants will be randomised into one of the four study arms (A, B, C and D). The arm A is non interventional. For arms B, C, and D, the three-month study drug treatment will be followed by 9 months of MDT, bringing the total treatment time to 12 months. This provision of MDT ensures that the participant has received the recommended standard treatment for leprosy and is primarily for ethics considerations.

Eligibility Criteria

Inclusion Criteria: * Be an individual aged 18-60 years. * Has been diagnosed with MB leprosy with a Bacillary Index (BI) of at least 2+ on a slit skin smear (SSS). * Have no prior leprosy treatment (WHO MDT and/or dapsone monotherapy). * Be able to give voluntary informed consent. * Be able to complete the full study period and follow-up (with no planned migration and an accurate, known and accessible address). * Be able to accept hospitalisation for at least three months (site-specific requirement). * "Body weight \< 85 kg at screening." (participants with weight \>= 85 kg have an increased risk of severe transaminitis under telacebec) Exclusion Criteria: * Unable to give voluntary informed consent. * Is a pregnant or breastfeeding woman. * Presenting with reinfection or relapse after WHO MDT/dapsone monotherapy, or has received anti-mycobacterial drugs in the last 30 days. * Presenting a leprosy reaction at diagnosis. * Being currently involved or having been involved within the last 30 days in a clinical trial. * Has any of the following medical conditions: a baseline QTcF of \>450 ms or a clinically significant ECG abnormality or significant heart disease; HIV co-infection; HBV co-infection; history of or current pancreatitis; known or suspected cirrhosis of the liver; active clinical tuberculosis; any condition which, in the opinion of the investigator, may cause harm to the patient; known alcohol or drug addiction; known uncontrolled chronic disease such as diabetes (HbA1c \>10%) or renal failure (GFR \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07918573). StuddyBuddy aggregates publicly available trial information.