This Phase 3 study is designed as a 24-week randomized, double-blind, placebo-controlled period (PCP) followed by a 144-week long-term extension (LTE) period. The primary objective of the PCP is to evaluate the effect of seralutinib on improving exercise capacity in subjects with World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease. The primary objective of the LTE is to evaluate the long-term safety and tolerability of seralutinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
Matching capsule containing placebo
Capsule containing seralutinib
Generic dry powder inhaler for seralutinib or placebo delivery
Valley Advanced Lung Diseases Institute
Fresno, California, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Hillel Yaffe Medical Center
Hadera, Israel
Change in distance achieved on the six-minute walk test (6MWT), from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Incidence of treatment-emergent adverse events
Time frame: From first dose of LTE study treatment through LTE Week 148
Time to first event of Adjudication Committee (AC)-confirmed clinical worsening from first dose of investigational product (IP) through PCP Week 24
Event is defined as: * Death (all causes) * Hospitalization for ≥ 24 hours due to a worsening cardiopulmonary indication * ≥ 15% 6MWD decline from baseline, directly related to PH-ILD assessed by two 6MWTs at least 4 hours apart and no more than 1 week apart
Time frame: Baseline to PCP Week 24
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Change in absolute forced vital capacity (FVC) from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Proportion of subjects meeting each AC-confirmed component of clinical worsening by PCP Week 24
Components of clinical worsening are defined for the first secondary outcome measure above.
Time frame: Baseline to PCP Week 24
Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to PCP Week 24
The EQ-5D-5L is a patient questionnaire that includes two components. The first is the EQ-5D-5L descriptive system, which profiles a subject's current health state across 5 dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Each dimension is comprised of a single question with 5 possible responses that are scored 1-5, corresponding to no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems, respectively. Higher scores for a dimension mean a worse outcome. The second is a visual analogue scale (EQ VAS), which asks a subject to assess their overall health. The EQ VAS has a range of 0-100, with a higher score representing a better outcome.
Time frame: Baseline to PCP Week 24
Change in Living with Pulmonary Fibrosis (L-PF) from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Changes in distance achieved on the 6MWT
Time frame: LTE Week 12 to LTE Week 148
Changes in NT-proBNP
Time frame: LTE Week 4 to LTE Week 148
Changes in absolute forced vital capacity (FVC)
Time frame: LTE Week 12 to LTE Week 148
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