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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH or PH-ILD. The study will determine the short-term and long-term safety and tolerability of L606 in this patient population.
This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of repeated doses of L606 in patients with PAH or PH-ILD.
Cohort A: Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso and willing to switch to L606.
Cohort B: Subjects with PAH (not initially on prostacyclin therapy) who are likely to receive clinical benefit from inhaled treprostinil based on the opinion of the investigator.
Cohort A subjects will sequentially participate in the Main Study Period (MSP) for 2 weeks and the Open Extension Period (OEP) for 46 weeks. Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L606 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L606 inhalation suspension | Combination Product | L606 inhalation suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs | (MSP for Cohort A): Proportion of patients with PAH or PH-ILD on a stable Tyvaso dose who would develop treatment-emergent AEs/SAEs after switching to L606 dosing for up to 2 weeks during MSP. | 2 weeks |
| Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs | (MSP for Cohort B): Proportion of patients with PAH (not initially on prostacyclin therapy) who would develop treatment-emergent AEs/SAEs during 12 weeks of the MSP with titration on twice daily L606. | 12 weeks |
| Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term) | (OEP for Cohorts A and B): Proportion of subjects with PAH or PH-ILD, choosing to continue twice daily L606 dosing for up to 48 weeks, who would develop treatment emergent AEs/SAEs up to 48 hours after the last dose. | 48 weeks |
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Key Inclusion Criteria:
Males and females ≥18 and ≤80 years of age.
Diagnosed with
Subjects with PAH: Documentation of having PAH as confirmed by RHC meeting the following criteria:
i. Mean PAP >20 mmHg. ii. Pulmonary arterial wedge pressure ≤15 mmHg. iii. Pulmonary vascular resistance >3 Wood units. Subjects with PH-ILD: Confirmation of the underlying ILD must be based on HRCT imaging with demonstration of diffuse parenchymal lung disease and documented by the Investigator or radiology report. Subjects may have any form of ILD or CPFE.
NYHA functional class II, III, or IV at the screening visit.
Can complete a screening 6MWD of ≥150 meters
For subjects with PAH: >65% of predicted and FEV1/FVC ratio >65% at screening. For subjects with PH-ILD: >40% of predicted and FEV1/FVC ratio >70% at screening.
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pulmonary Specialists | Scottsdale | Arizona | 85258 | United States | ||
| VA Greater Los Angeles Healthcare |
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Cohort A: Tyvaso stabilized PAH or PH-ILD patients Cohort B: Prostacyclin naive - PAH patients
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| Los Angeles |
| California |
| 90073 |
| United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6504 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Summit Health Eastside Clinic | Bend | Oregon | 97701 | United States |
| Baylor Scott and White Research Institute | Temple | Texas | 76508 | United States |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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