Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

Phase 3

Recruiting

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Seralutinib; Device: Gereic Dry Powder Inhaler

• Registration Number: NCT06274801
• Lead Sponsor: GB002, Inc.

Brief Summary

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Detailed Description

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-23
• Study Start: 2024-09-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
5. 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.
6. 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.

Read More

Exclusion Criteria

1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seralutinib 90 mg	Seralutinib	Seralutinib inhaled orally twice per day (BID)
Seralutinib 90 mg	Gereic Dry Powder Inhaler	Seralutinib inhaled orally twice per day (BID)

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	From baseline to end of study (up to 48 months or availability of commercial product)

Secondary Outcome Measures

Name	Time	Method
Changes in distance achieved on the Six-Minute Walk Test (6MWT)	Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)	Δ6MWT from Baseline to End of Study
Changes in NT-proBNP	Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)	Change in NT-proBNP from Baseline to End of Study

Trial Locations

Locations (24)

Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie; 🇩🇪 Heidelberg, Germany

Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin; 🇩🇪 Würzburg, Germany

AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic; 🇬🇷 Thessaloníki, Greece

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Norton Pulmonary Specialists; 🇺🇸 Louisville, Kentucky, United States

Pulmonary Associates of Richmond, Inc.; 🇺🇸 Richmond, Virginia, United States

Cardiologia Palermo; 🇦🇷 Buenos Aires, Argentina

Instituto de Cardiologia de Corrientes Juana Francisca Cabral; 🇦🇷 Corrientes, Argentina

Instituto Medico Rio Cuarto; 🇦🇷 Río Cuarto, Argentina

Hospital Provincial Dr. Jose Maria Cullen; 🇦🇷 Santa Fe, Argentina

St Vincent's Hospital (Melbourne); 🇦🇺 Fitzroy, Australia

Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze; 🇨🇿 Praha, Czechia

Aarhus Universiteshospital; 🇩🇰 Aarhus, Denmark

CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie; 🇫🇷 Le Kremlin-Bicêtre, France

CHU de Nice - Hopital Pasteur; 🇫🇷 Nice, France

Lady Davis Carmel Medical Center; 🇮🇱 Haifa, Israel

A.O.U. Policlinico Umberto I; 🇮🇹 Roma, Italy

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos; 🇱🇹 Kaunas, Lithuania

Hospital Clinic I Provincial; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain