Trials / Completed
CompletedNCT05934526
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 390 (actual)
- Sponsor
- GB002, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Matching capsule containing placebo |
| DRUG | Seralutinib | Capsule containing seralutinib |
| DEVICE | Generic Dry Powder Inhaler | Generic dry powder inhaler for seralutinib or placebo delivery |
Timeline
- Start date
- 2023-12-28
- Primary completion
- 2025-11-27
- Completion
- 2025-12-22
- First posted
- 2023-07-07
- Last updated
- 2026-04-09
Locations
166 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05934526. Inclusion in this directory is not an endorsement.