Pulmonary Hypertension Associated With Interstitial Lung DiseasePhase 3SERANATANCT07181382
Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
A Phase 3 study testing Seralutinib and Generic Dry Powder Inhaler in people with Pulmonary Hypertension Associated With Interstitial Lung Disease, run by GB002, Inc. at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension Associated With Interstitial Lung Disease
- What is being tested?
- Seralutinib and Generic Dry Powder Inhaler
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
- Subjects with a history of severe milk protein allergy.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) of > 500 msec.
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Valley Advanced Lung Diseases Institute
Fresno, California, 93720
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) Followed by a Long-Term Extension Evaluating Safety and Efficacy
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.
- Being tested
- Placebo, Seralutinib, Generic Dry Powder Inhaler
- Keywords
- seralutinib, GB002, SERANATA, Pulmonary hypertension, Interstitial lung disease
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching capsule containing placebo
SeralutinibDrug
Capsule containing seralutinib
Generic Dry Powder InhalerDevice
Generic dry powder inhaler for seralutinib or placebo delivery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo inhaled orally twice daily (BID) for 24 weeks in PCP. Subjects randomized to the placebo treatment group in the PCP will receive seralutinib in LTE. Receives: Drug: Placebo; Drug: Seralutinib; Device: Generic Dry Powder Inhaler |
| Seralutinib 90 mg | Experimental | Seralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE. Receives: Drug: Seralutinib; Device: Generic Dry Powder Inhaler |
| Seralutinib 120 mg | Experimental | Seralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE. Receives: Drug: Seralutinib; Device: Generic Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distance achieved on the six-minute walk test (6MWT), from baseline to PCP Week 24
Measured: Baseline to PCP Week 24
Incidence of treatment-emergent adverse events
Measured: From first dose of LTE study treatment through LTE Week 148
Secondary outcomes (9)
Time to first event of Adjudication Committee (AC)-confirmed clinical worsening from first dose of investigational product (IP) through PCP Week 24
Event is defined as:
- Death (all causes)
- Hospitalization for ≥ 24 hours due to a worsening cardiopulmonary indication
- ≥ 15% 6MWD decline from baseline, directly related to PH-ILD assessed by two 6MWTs at least 4 hours apart and no more than 1 week apart
Measured: Baseline to PCP Week 24
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to PCP Week 24
Measured: Baseline to PCP Week 24
Change in absolute forced vital capacity (FVC) from baseline to PCP Week 24
Measured: Baseline to PCP Week 24
Proportion of subjects meeting each AC-confirmed component of clinical worsening by PCP Week 24
Components of clinical worsening are defined for the first secondary outcome measure above.
Measured: Baseline to PCP Week 24
Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to PCP Week 24
The EQ-5D-5L is a patient questionnaire that includes two components. The first is the EQ-5D-5L descriptive system, which profiles a subject's current health state across 5 dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Each dimension is comprised of a single question with 5 possible responses that are scored 1-5, corresponding to no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems, respectively. Higher scores for a dimension mean a worse outcome. The second is a visual analogue scale (EQ VAS), which asks a subject to assess their overall health. The EQ VAS has a range of 0-100, with a higher score representing a better outcome.
Measured: Baseline to PCP Week 24
Change in Living with Pulmonary Fibrosis (L-PF) from baseline to PCP Week 24
Measured: Baseline to PCP Week 24
Changes in distance achieved on the 6MWT
Measured: LTE Week 12 to LTE Week 148
Changes in NT-proBNP
Measured: LTE Week 4 to LTE Week 148
Changes in absolute forced vital capacity (FVC)
Measured: LTE Week 12 to LTE Week 148
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study startFeb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Associated With Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GB002, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Sponsor
- Investigators
- Richard Aranda, MD, Study director, Gossamer Bio USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181382
- Sponsor's protocol ID
- GB002-3201
- Other IDs
- 2025-521777-13-00, 2025
- Acronym
- SERANATA
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) Followed by a Long-Term Extension Evaluating Safety and Efficacy
- ClinicalTrials.gov ID
- NCT07181382
- Acronym / sponsor ID
- SERANATA / GB002-3201
- Keywords
- seralutinib, GB002, SERANATA, Pulmonary hypertension, Interstitial lung disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor decision
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- GB002, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: Seralutinib, Device: Generic Dry Powder InhalerPlacebo inhaled orally twice daily (BID) for 24 weeks in PCP. Subjects randomized to the placebo treatment group in the PCP will receive seralutinib in LTE. |
| Seralutinib 90 mg | Experimental | Drug: Seralutinib, Device: Generic Dry Powder InhalerSeralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE. |
| Seralutinib 120 mg | Experimental | Drug: Seralutinib, Device: Generic Dry Powder InhalerSeralutinib inhaled orally BID for 24 weeks in PCP. Seralutinib inhaled orally BID up to 144 weeks in LTE. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- Forced vital capacity (FVC) ≥ 45% predicted at Screening.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching capsule containing placebo | Drug | Placebo |
| SeralutinibCapsule containing seralutinib | Drug | Placebo, Seralutinib 120 mg, Seralutinib 90 mg |
| Generic Dry Powder InhalerGeneric dry powder inhaler for seralutinib or placebo delivery | Device | Placebo, Seralutinib 120 mg, Seralutinib 90 mg |
Primary outcome
Change in distance achieved on the six-minute walk test (6MWT), from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Incidence of treatment-emergent adverse events
Time frame: From first dose of LTE study treatment through LTE Week 148
9 secondary outcomes
Time to first event of Adjudication Committee (AC)-confirmed clinical worsening from first dose of investigational product (IP) through PCP Week 24
Time frame: Baseline to PCP Week 24
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Change in absolute forced vital capacity (FVC) from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Proportion of subjects meeting each AC-confirmed component of clinical worsening by PCP Week 24
Time frame: Baseline to PCP Week 24
Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Change in Living with Pulmonary Fibrosis (L-PF) from baseline to PCP Week 24
Time frame: Baseline to PCP Week 24
Changes in distance achieved on the 6MWT
Time frame: LTE Week 12 to LTE Week 148
Changes in NT-proBNP
Time frame: LTE Week 4 to LTE Week 148
Changes in absolute forced vital capacity (FVC)
Time frame: LTE Week 12 to LTE Week 148
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Aranda, MD study director
Gossamer Bio USA, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seralutinib and Generic Dry Powder Inhaler in people with Pulmonary Hypertension Associated With Interstitial Lung Disease, run by GB002, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in distance achieved on the six-minute walk test (6MWT), from baseline to PCP Week 24 (time frame: Baseline to PCP Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.