Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06114628 | Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB | PHASE2 | RECRUITING | 2,500 | — | — | Jan 9, 2024 | Aug 11, 2027 | Oct 6, 2025 | 11 | Moldova, South Africa +3 |
Primary Efficacy Outcome in Phase 2B, rate of change in log10(Time to positivity)
Primary Efficacy Outcome in Phase 2C, the proportion of participants with a favourable outcome status
| Arm | Type | Description |
|---|---|---|
| A. Standard TB Regimen. 2HRZE/4HR | ACTIVE_COMPARATOR | 24 weeks treatment in both Phase 2B and 2C - 8 weeks Rifampicin, Isoniazid, Pyrazinamide, Ethambutol followed by 16 weeks Rifampicin and Isoniazid. |
| Arm B. BDM | EXPERIMENTAL | Bedaquiline, Delamanid, Moxifloxacin for 16 weeks in Phase 2B |
| Arm C. BDM + Gan | EXPERIMENTAL | Bedaquiline, Delamanid, Moxifloxacin and Ganfeborole for 16 weeks in Phase 2B Bedaquiline, Delamanid, Moxifloxacin and Ganfeborole for 8-16 weeks in phase 2C |
| Arm D. BDZ + Gan | EXPERIMENTAL | Bedaquiline, Delamanid, Pyrazinamide and Ganfeborole for 16 weeks in Phase 2B Bedaquiline, Delamanid, Pyrazinamide and Ganfeborole for 8-16 weeks in phase 2C |
| Arm E. BDL + 656 | EXPERIMENTAL | Bedaquiline, Delamanid, Linezolid and Ganfeborole for 8 weeks followed by 8 weeks Bedaquiline, Delamanid and Ganfeborole in Phase 2B Bedaquiline, Delamanid, Linezolid and Ganfeborole for 8 weeks followed by 0-8 weeks Bedaquiline, Delamanid and Ganfeborole in Phase 2C |
| Arm F. BPaM + Gan | EXPERIMENTAL | Bedaquiline, Pretomanid, Moxifloxacin and Ganfeborole for 16 weeks in Phase 2B Bedaquiline, Pretomanid, Moxifloxacin and Ganfeborolefor 8-16 weeks in Phase 2C |
| Arm G. BDM + BTZ-043 | EXPERIMENTAL | Bedaquiline, Delamanid, Moxifloxacin and BTZ-043 for 16 weeks in Phase 2B Bedaquiline, Delamanid, Moxifloxacin and BTZ-043 for 8-16 weeks in phase 2C |
| Arm H. BDZ + BTZ-043 | EXPERIMENTAL | Bedaquiline, Delamanid, Pyrazinamide and BTZ-043 for 16 weeks in Phase 2B Bedaquiline, Delamanid, Pyrazinamide and BTZ-043 for 8-16 weeks in phase 2C |
| Arm I. BDL + BTZ-043 | EXPERIMENTAL | Bedaquiline, Delamanid, Linezolid and BTZ-043 for 8 weeks followed by 8 weeks Bedaquiline, Delamanid and BTZ-043 in Phase 2B Bedaquiline, Delamanid, Linezolid and BTZ-043 for 8 weeks followed by 0-8 weeks Bedaquiline, Delamanid and BTZ-043 in Phase 2C |
| Arm J. BPaM + BTZ-043 | EXPERIMENTAL | Bedaquiline, Pretomanid, Moxifloxacin and BTZ-043 for 16 weeks in Phase 2B Bedaquiline, Pretomanid, Moxifloxacin and BTZ-043 for 8-16 weeks in Phase 2C |
| Arm K. BMZ + BTZ-043 | EXPERIMENTAL | Bedaquiline, Moxifloxacin, Pyrazinamide and BTZ-043 for 16 weeks in Phase 2B Bedaquiline, Moxifloxacin, Pyrazinamide and BTZ-043 for 8-16 weeks in phase 2C |
| Arm L. BD + Gan + BTZ-043 | EXPERIMENTAL | Bedaquiline, Delamanid, Ganfeborole and BTZ-043 for 16 weeks in Phase 2B Bedaquiline, Delamanid, Ganfeborole and BTZ-043 for 8-16 weeks in phase 2C |
| Arm M: BDM + Q | EXPERIMENTAL | Bedaquiline, delamanid, moxifloxacin, quabodepistat for 16 weeks in Phase 2B |
| Arm N: BPAM + Q | EXPERIMENTAL | Bedaquiline, pretomanid, moxifloxacin, quabodepistat for 16 weeks in Phase 2B |
| Arm O: BD + Gan + Q | EXPERIMENTAL | Bedaquiline, delamanid, ganfeborole, quabodepistat for 16 weeks in Phase 2B |
| Arm P: BPa + Gan +Q | EXPERIMENTAL | Bedaquiline, pretomanid, ganfeborole, quabodepistat for 16 weeks in Phase 2B |
| Arm Q: BPa + DZD + BTZ-043 | EXPERIMENTAL | Bedaquiline, pretomanid, delpazolid, BTZ-043 for 16 weeks in Phase 2B |
| Name | Type | Description |
|---|---|---|
| Ganfeborole | DRUG | Oral daily dosage of 20mg. |
| BTZ-043 | DRUG | Oral daily dosage of 1000mg. |
| Bedaquiline (B) | DRUG | Oral daily dosage of 400mg for the first 2 weeks, thereafter 100mg daily until end of treatment. |
| Delamanid (D) | DRUG | Oral daily dosage of 300mg. |
| Pretomanid (Pa) | DRUG | Oral daily dosage of 200mg. |
| Moxifloxacin (M) | DRUG | Oral daily dosage of 400mg. |
| Linezolid (L) | DRUG | Oral daily dosage of 600mg for the first 8 weeks. |
| Pyrazinamide (Z) | DRUG | Oral daily dosage of 1200mg-2000mg depending on weight. |
| Rifampicin (R) | DRUG | Oral daily dosage of 450mg-750mg depending on weight. |
| Isoniazid (H) | DRUG | Oral daily dosage of 225mg-375mg depending on weight. |
| Ethambutol (E) | DRUG | Oral daily dosage of 825mg-1375mg depending on weight. |
| Delpazolid (DZD) | DRUG | Oral daily dosage of 1200mg |
| Quabodepistat (Q) | DRUG | Oral daily dosage of 30mg |
Inclusion Criteria: 1. Age 18 years or above at screening (or above age of legal consent at screening, if this is higher than 18 years in the jurisdiction in which the study is taking place) 2. Clinical evidence of active TB disease, meeting either or both of the following criteria: * Symptoms ...