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 Hypertension Associated With Interstitial Lung Disease (PH-ILD) Followed by a Long-Term Extension Evaluating Safety and Efficacy
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.
• Adult subjects aged 18 years to 80 years, inclusive, at the time of voluntarily signing the informed consent form, prior to initiation of any study-specific activities/procedures.
• Body mass index (BMI) ≥ 15 kg/m2 and ≤ 40 kg/m2.
• A diagnosis of WHO Group 3 pulmonary hypertension (PH) associated with interstitial lung disease.
• Right heart catheterization at Screening meeting the following criteria:
∙ Pulmonary vascular resistance (PVR) ≥ 4 Woods Units, AND
‣ Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mm Hg, AND
‣ Mean pulmonary arterial pressure (mPAP) ≥ 25 mm Hg. Historic RHC up to 12 weeks prior to Screening may be acceptable for eligibility.
• Forced vital capacity (FVC) ≥ 45% predicted at Screening.
• Screening 6MWD of ≥ 100 m and ≤ 475 m.
• Subjects receiving permitted chronic medication for underlying fibrotic ILD must be receiving background therapy from at least 16 weeks prior to Screening.
• Subjects receiving SARD medication must be receiving background therapy from at least 16 weeks prior to Screening.
• Subjects on supportive medications (eg, diuretics) must be on an optimized dose for ≥ 30 days prior to and throughout Screening.
⁃ In the opinion of the Investigator, the subject has no other medical conditions that impair the proper use of the inhaler.
⁃ Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on PCP Day 1 before first administration of IP.
⁃ WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
⁃ Women of nonchildbearing potential (WONCBP), classified by 1 of the following:
• Surgical sterilization
∙ Evidence of post-menopausal status.
⁃ Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.