drugset / Trial / NCT05971602
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
Phase 2
Terminated
93 enrolled
Gates Medical Research Institute
Global Alliance for TB Drug Development · collabJanssen Pharmaceuticals · collabOtsuka Pharmaceutical Co., Ltd. · collab
RandomizedSequentialOpen-labelTreatment
Summary
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).
Timeline
- Start
- 2023-07-26
- Primary completion
- 2025-02-06
- Completion
- 2025-02-06
Outcome
Outcome not reported
Stopped: “Data generated in the Gates MRI-TBD06-201 trial do not support the investigational regimens being able to achieve the trial objective of identifying a new regimen to treat tuberculosis in 3 months or less.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | — |
| Subject | Delamanid | Small molecule | 300 mg | — |
| Subject | Ethambutol | Small molecule | 275 mg | — |
| Subject | Isoniazid | Small molecule | 75 mg | — |
| Subject | Pretomanid | Small molecule | 200 mg | — |
| Subject | Pyrazinamide | Small molecule | 400 mg | — |
| Subject | Quabodepistat | Small molecule | 30 mg | — |
| Subject | Rifampicin | Small molecule | 150 mg | — |
| Subject | Sutezolid | Small molecule | 1200 mg | — |