New inhaled drug aims to help patients with lung scarring and high blood pressure

NCT ID NCT07181382

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Hillel Yaffe Medical Center

    Hadera, Israel

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230, United States

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131, United States

  • Valley Advanced Lung Diseases Institute

    Fresno, California, 93720, United States

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