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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in distance achieved on the six-minute walk test (6MWT), from baseline to PCP Week 24

Timeframe: Baseline to PCP Week 24

Incidence of treatment-emergent adverse events

Timeframe: From first dose of LTE study treatment through LTE Week 148

Trial details

NCT IDNCT07181382

SponsorGB002, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Pulmonary Hypertension Associated With Interstitial Lung Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria