Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Paused · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension Associated With Interstitial Lung Disease

In brief

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.

Key facts

Study ID

NCT07181382

Run by

GB002, Inc.

People needed

480

Starts

2026-02-01

Expected to finish

2028-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Diagnosis of pulmonary arterial hypertension (PAH) or PH other than WHO Group 3.
• 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.
• Untreated moderate or severe obstructive sleep apnea.
• Clinically significant history of liver disease (ie, Child-Pugh Class A - C, viral hepatitis, liver cirrhosis, hepatobiliary disorders, etc).
• History of malignancy within 5 years prior to Screening, with the exception of localized and adequately treated non-metastatic basal and squamous cell carcinoma of the skin and in-situ carcinoma of the cervix.
• Uncontrolled bacterial, viral, or fungal infections which require ongoing systemic therapy.
• Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration, or absolute neutrophil count (ANC) < 1 x 109/L.
• Pregnant or nursing or intends to become pregnant during the duration of the study.
• Major surgical procedures planned to occur during trial period.
• Any other medical condition or laboratory abnormality that, in the opinion of the Investigator, would prohibit the subject from participating in the study, eg, severe concomitant illness limiting life expectancy (< 24 weeks).
• Body weight < 40 kg at Screening.
• Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2
• Evidence of active Hepatitis B or Hepatitis C, or active tuberculosis (TB) infections at Screening.
• Subjects receiving both nintedanib and pirfenidone.
• Initiation of an exercise program for cardiopulmonary rehabilitation within 12 weeks prior to and throughout Screening or planned during their time on the PCP.
• Prior participation in seralutinib studies and/or prior treatment with seralutinib.
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device for the treatment of PH-ILD within 12 weeks or 5 half-lives of the investigational agent, whichever is longer, prior to Screening.
• Current use or within 24 weeks prior to Randomization of inhaled tobacco- or nicotine-containing products (including e-vapor products) and/or inhaled marijuana.
• Current alcohol use disorder based on the opinion of the Investigator, and/or a positive test for drugs of abuse at Screening.

Where it is running

• 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

Full record on ClinicalTrials.gov

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