NCT05221502

Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB

A Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid, ethambutol, pyrazinamide (RHEZ) administered for 26 weeks.

Detailed description

Eligible participants for this study have a diagnosis of pulmonary DS-TB. This is a Phase 2b/c multicenter, open-label, randomized, dose-finding study, consisting of up to 26 weeks of treatment period. Following a screening period of up to 14 days, eligible participants will be randomized in the study. Randomization will be stratified by presence of bilateral cavitation on screening chest x-ray (yes or no). After the end of the treatment period, participants will be followed until 12 months post randomization.

Conditions

• Pulmonary TB

Interventions

Type	Name	Description
DRUG	Delamanid + Bedaquiline + OPC-167832 10 mg	Delamanid (300 mg QD) + Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (10 mg QD) for 17 weeks
DRUG	Delamanid + Bedaquiline + OPC-167832 30 mg	Delamanid (300 mg QD\] + Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (30 mg QD) for 17 weeks
DRUG	Delamanid + Bedaquiline + OPC-167832 90 mg	Delamanid (300 mg QD) + Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (90 mg QD) for 17 weeks
DRUG	RHEZ	RHEZ for 8 weeks followed by 18 weeks of rifampin and isoniazid (for a total of 26 weeks)

Timeline

• Start date: 2022-04-12
• Primary completion: 2024-04-08
• Completion: 2024-05-19
• First posted: 2022-02-03
• Last updated: 2025-04-10

Locations

6 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study