NCT07350174

Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis

A Multicenter, Open-label, Randomized, Active-controlled, Phase 2a Study to Evaluate the Pharmacokinetics and Safety of Alpibectir/Ethionamide in Combination With the Standard Regimen in Patients With Tuberculosis Meningitis.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: BioVersys AG · Industry
• Sex: All
• Age: 15 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

AlpE is a novel drug combination under development for the treatment of TB, with several positive attributes for TBM, including rapid bactericidal activity. The current trial aims to assess the plasma and CSF PK, as well as the safety and tolerability of alpibectir and three doses of Eto in patients with newly diagnosed TBM. Additionally, it is attended to investigate the effect of AlpE on the PK and efficacy of DTG during the first month of antiretroviral treatment (ART) for Human Immunodeficiency Virus (HIV)-positive patients.

Conditions

• Tuberculosis Meningitis

Interventions

Type	Name	Description
DRUG	HRZE	Isoniazid (5 mg/kg/day); Rifampicin (10 mg/kg/day); Pyrazinamide (30 mg/kg/day); Ethambutol (20 mg/kg/day).
DRUG	HRZE plus Alpe375	isoniazid (5 mg/kg/day); rifampicin (10 mg/kg/day); pyrazinamide (30 mg/kg/day); ethambutol (20 mg/kg/day), Alpe375 (alpibectir (30 mg/day), ethionamide (375 mg/day))
DRUG	HRZE plus AlpE500	isoniazid (5 mg/kg/day); rifampicin (10 mg/kg/day); pyrazinamide (30 mg/kg/day); ethambutol (20 mg/kg/day), Alpe375 (alpibectir (30 mg/day), ethionamide (500 mg/day))
DRUG	HRZE plus AlpE625	isoniazid (5 mg/kg/day); rifampicin (10 mg/kg/day); pyrazinamide (30 mg/kg/day); ethambutol (20 mg/kg/day), Alpe375 (alpibectir (30 mg/day), ethionamide (625 mg/day))

Timeline

• Start date: 2026-03-30
• Primary completion: 2028-03-30
• Completion: 2028-10-30
• First posted: 2026-01-20
• Last updated: 2026-03-03

Regulatory

• FDA-regulated drug study