This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
330
Capsule containing seralutinib
Generic dry powder inhaler for seralutinib delivery
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From baseline to end of study (up to 48 months or availability of commercial product)
Changes in distance achieved on the Six-Minute Walk Test (6MWT)
Δ6MWT from Baseline to End of Study
Time frame: Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Changes in NT-proBNP
Change in NT-proBNP from Baseline to End of Study
Time frame: Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
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