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New inhaled drug shows promise for rare lung disease

NCT ID NCT04816604

Disease control Sponsor: Gossamer Bio USA, Inc. Source: ClinicalTrials.gov ↗

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
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study looks at the long-term safety of an inhaled drug called GB002 for people with pulmonary arterial hypertension (PAH), a serious lung condition. It includes 74 patients who already completed a previous GB002 study. Researchers will track side effects and measure how far patients can walk in six minutes to see if the drug helps over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GB002 (seralutinib) inhaled via a dry powder inhaler
What this could lead to
If successful, this could provide a new inhaled treatment option to help control pulmonary arterial hypertension and improve patients' ability to walk.
What could go wrong
This is a small, early-phase extension study with no placebo group, so results may not prove effectiveness. Long-term safety is still unknown, and side effects may emerge.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

74 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Dec 2027

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: Type of Subject and Disease Characteristics 1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit. 2. Treatment with standard of care PAH disease-specific background therapies (stable dose). Informed Consent 3. Review and signature of an IRB-approved informed consent form. Exclusion Criteria: Medical Conditions 1. Persistent and clinically significant systemic hypertension or hypotension. 2. Interval history of newly developed left-sided heart disease. 3. Potentially life-threatening cardiac arrhythmia with an ongoing risk. 4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy. 5. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. 6. History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher. 7. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose. 8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations. 9. Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \[PCP\]). 10. Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in the study. Diagnostic Assessments 11. Chronic renal insufficiency 12. Hemoglobin (Hgb) concentration \<8.5 g/dL. 13. Absolute neutrophil count (ANC) \< 1x 10\^9/L. 14. Platelet count \<50 x 10\^9/L. Prior Therapy 15. Use of inhaled prostanoids. 16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant \[NOAC\]/direct oral anticoagulant \[DOAC\]). 17. Chronic use of any prohibited medication. NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • AP-HP Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • DRK Kliniken Berlin

    Berlin, Germany

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • INTEGRIS Baptist Medical Center, Inc.

    Oklahoma City, Oklahoma, 73112, United States

  • Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited

    London, United Kingdom

  • Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule

    Hanover, 30625, Germany

  • Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Medical Corporation

    Santa Barbara, California, 93105, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • New York Presbyterian Hospital - Weill Cornell Medicine

    New York, New York, 10065, United States

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202, United States

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, CB2 OAY, United Kingdom

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, 69126, Germany

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V

    Giessen, Germany

  • University of California, Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Utah Health

    Salt Lake City, Utah, 84132, United States

  • Všeobecná fakultní nemocnice v Praze

    Prague, 128 08, Czechia

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