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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04816604 | Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) | PHASE2 | ACTIVE NOT_RECRUITING | 74 | — | — | Apr 5, 2021 | Dec 1, 2027 | Apr 9, 2026 | 28 | United States, Australia +5 |
| NCT03926793 | Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension | PHASE1 | COMPLETED | 8 | — | — | Feb 4, 2020 | May 5, 2021 | Sep 1, 2021 | 14 | United States, United Kingdom |
To evaluate the safety and tolerability of GB002
To evaluate the long-term safety and tolerability and efficacy of GB002
| Arm | Type | Description |
|---|---|---|
| GB002 (seralutinib) | EXPERIMENTAL | GB002 (seralutinib) inhaled orally twice per day (BID) |
| Cohort 1 | EXPERIMENTAL | Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days |
| Cohort 2 | EXPERIMENTAL | Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days |
| Open Label Extension | EXPERIMENTAL | Eligible subjects may participate in the Open Label Extension (OLE) study for a period of 24 weeks. |
| Name | Type | Description |
|---|---|---|
| GB002 (seralutinib) | DRUG | Capsule containing GB002 (seralutinib) |
| Generic Dry Powder Inhaler | DEVICE | Generic dry powder inhaler for GB002 (seralutinib) delivery |
| GB002 | DRUG | GB002 low dose or high dose for inhalation |
| Placebo | DRUG | Placebo for inhalation |
Inclusion Criteria: Type of Subject and Disease Characteristics 1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) vi...