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New inhaled drug aims to help patients with lung scarring and high blood pressure
NCT ID NCT07181382
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests an inhaled drug called seralutinib for people with pulmonary hypertension (high blood pressure in the lungs) caused by interstitial lung disease (lung scarring). About 480 adults will receive either seralutinib or a placebo for 24 weeks, followed by a long-term safety extension. The main goal is to see if the drug improves how far patients can walk in six minutes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- seralutinib (inhaled powder)
- What this could lead to
- If it works, this could offer a new treatment option to improve exercise ability and slow worsening for people with pulmonary hypertension due to lung scarring.
- What could go wrong
- This trial is suspended, so results are uncertain. Even if effective, it may only help a subset of patients and side effects from the drug or inhaler are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Body mass index (BMI) ≥ 15 kg/m2 and ≤ 40 kg/m2. 3. A diagnosis of WHO Group 3 pulmonary hypertension (PH) associated with interstitial lung disease. 4. Right heart catheterization at Screening meeting the following criteria: 1. Pulmonary vascular resistance (PVR) ≥ 4 Woods Units, AND 2. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mm Hg, AND 3. Mean pulmonary arterial pressure (mPAP) ≥ 25 mm Hg. Historic RHC up to 12 weeks prior to Screening may be acceptable for eligibility. 5. Forced vital capacity (FVC) ≥ 45% predicted at Screening. 6. Screening 6MWD of ≥ 100 m and ≤ 475 m. 7. Subjects receiving permitted chronic medication for underlying fibrotic ILD must be receiving background therapy from at least 16 weeks prior to Screening. 8. Subjects receiving SARD medication must be receiving background therapy from at least 16 weeks prior to Screening. 9. Subjects on supportive medications (eg, diuretics) must be on an optimized dose for ≥ 30 days prior to and throughout Screening. 10. In the opinion of the Investigator, the subject has no other medical conditions that impair the proper use of the inhaler. 11. 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. 12. 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. 13. Women of nonchildbearing potential (WONCBP), classified by 1 of the following: 1. Surgical sterilization 2. Evidence of post-menopausal status. 14. 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. Exclusion Criteria: 1. Diagnosis of pulmonary arterial hypertension (PAH) or PH other than WHO Group 3. 2. PH associated with sarcoidosis, combined pulmonary fibrosis and emphysema, chronic obstructive pulmonary disease, or progressive massive fibrosis. 3. Human immunodeficiency virus (HIV). 4. Uncontrolled atrial fibrillation or paroxysmal atrial fibrillation. 5. History of a potentially life-threatening cardiac arrhythmia with an ongoing risk. 6. Uncontrolled systemic hypertension 7. 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. 8. Acute pulmonary embolism within 12 weeks prior to and throughout Screening. 9. Untreated moderate or severe obstructive sleep apnea. 10. Clinically significant history of liver disease (ie, Child-Pugh Class A - C, viral hepatitis, liver cirrhosis, hepatobiliary disorders, etc). 11. 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. 12. Uncontrolled bacterial, viral, or fungal infections which require ongoing systemic therapy. 13. 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. 14. Pregnant or nursing or intends to become pregnant during the duration of the study. 15. Major surgical procedures planned to occur during trial period. 16. 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). 17. Body weight \< 40 kg at Screening. 18. Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2 19. Evidence of active Hepatitis B or Hepatitis C, or active tuberculosis (TB) infections at Screening. 20. Subjects receiving both nintedanib and pirfenidone. 21. Initiation of an exercise program for cardiopulmonary rehabilitation within 12 weeks prior to and throughout Screening or planned during their time on the PCP. 22. Prior participation in seralutinib studies and/or prior treatment with seralutinib. 23. 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. 24. Current use or within 24 weeks prior to Randomization of inhaled tobacco- or nicotine-containing products (including e-vapor products) and/or inhaled marijuana. 25. Current alcohol use disorder based on the opinion of the Investigator, and/or a positive test for drugs of abuse at Screening. 26. Subjects with a history of severe milk protein allergy. 27. QT interval corrected for heart rate using Fridericia's formula (QTcF) of \> 500 msec. 28. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or has any disease or condition that would likely be the primary limit to ambulation (as opposed to PH). NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hillel Yaffe Medical Center
Hadera, Israel
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Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230, United States
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
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Valley Advanced Lung Diseases Institute
Fresno, California, 93720, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New inhaled drug aims to ease lung scarring and heart strain
- New inhaled powder for lung blood pressure condition tested in 80 patients
- New combo therapy for lung scarring and high blood pressure under study
- New drug APL-9796 tested for lung blood pressure disorder
- Inhaled drug tested for long-term safety in lung-related high blood pressure