Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With … (NCT07181382) | Clinical Trial Compass
SuspendedPhase 3
Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Stopped: Sponsor decision
United States, Israel480 participantsStarted 2026-02
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Diagnosis of pulmonary arterial hypertension (PAH) or PH other than WHO Group 3.
What they're measuring
1
Change in distance achieved on the six-minute walk test (6MWT), from baseline to PCP Week 24
Timeframe: Baseline to PCP Week 24
2
Incidence of treatment-emergent adverse events
Timeframe: From first dose of LTE study treatment through LTE Week 148
✕. PH associated with sarcoidosis, combined pulmonary fibrosis and emphysema, chronic obstructive pulmonary disease, or progressive massive fibrosis.
✕. Human immunodeficiency virus (HIV).
✕. Uncontrolled atrial fibrillation or paroxysmal atrial fibrillation.
✕. History of a potentially life-threatening cardiac arrhythmia with an ongoing risk.
✕. Uncontrolled systemic hypertension
✕. Subjects receiving \> 10 L/min of oxygen supplementation via nasal cannula at rest or \> 15 L/min during six-minute walk tests conducted during Screening.
✕. Acute pulmonary embolism within 12 weeks prior to and throughout Screening.