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

NCT07181382 | Suspended Phase 3 DMC FDA Drug

• 2 other identifiers: GB002-32012025-521777-13-00
• Study Type: interventional
• Target: 480
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Pulmonary Hypertension Associated With Interstitial Lung Disease

Keywords

seralutinib; GB002; SERANATA; Pulmonary hypertension; Interstitial lung disease

Outcome Measures

Primary Outcomes (2)

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

  Baseline to PCP Week 24

• Incidence of treatment-emergent adverse events

  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

  Baseline to PCP Week 24

• Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to PCP Week 24

  Baseline to PCP Week 24

• Change in absolute forced vital capacity (FVC) from baseline to PCP Week 24

  Baseline to PCP Week 24

• Proportion of subjects meeting each AC-confirmed component of clinical worsening by PCP Week 24

  Baseline to PCP Week 24

• Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to PCP Week 24

  Baseline to PCP Week 24

Study Arms (3)

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.

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.

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.

Drug: Seralutinib; Device: Generic Dry Powder Inhaler

Interventions

Placebo DRUG

Matching capsule containing placebo

Placebo

Seralutinib DRUG

Capsule containing seralutinib

Placebo; Seralutinib 120 mg; Seralutinib 90 mg

Generic Dry Powder Inhaler DEVICE

Generic dry powder inhaler for seralutinib or placebo delivery

Placebo; Seralutinib 120 mg; Seralutinib 90 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• GB002, Inc.: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (4)

Valley Advanced Lung Diseases Institute

Fresno, California, 93720, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230, United States

Location

Hillel Yaffe Medical Center

Hadera, Israel

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard Aranda, MD

  Gossamer Bio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); IL (1)