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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05496374 | A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease | PHASE2 | COMPLETED | 25 | — | — | Dec 14, 2022 | Dec 2, 2024 | Oct 9, 2025 | 28 | United States |
| Arm | Type | Description |
|---|---|---|
| Investigator Blind: Placebo | PLACEBO_COMPARATOR | Participants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days. |
| Investigator Blind: SPR720 500 mg | EXPERIMENTAL | Participants received SPR720 500 mg (250 mg × 2) capsules along with 2 SPR720 matching- placebo capsules, orally, QD for 56 days. |
| Investigator Blind: SPR720 1000 mg | EXPERIMENTAL | Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. |
| Open-label: SPR720 1000 mg | EXPERIMENTAL | Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. |
| Open-label: SPR720 500 mg | EXPERIMENTAL | Participants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo-matching capsules was administered orally. |
| SPR720 500 mg | DRUG | SPR720 500 mg (250 mg × 2 capsules) was administered orally. |
| SPR720 1000 mg | DRUG | SPR720 500 mg (250 mg × 4 capsules) was administered orally. |
Inclusion Criteria: 1. Has a prior diagnosis of NTM-PD due to MAC according to American Thoracic Society (ATS) criteria 2. Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage \[BAL\]) positive for MAC in the 12 months prior to consent 3. Has an induced sputum culture ...