Menu
Recruiting NCT06274801

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

Phase III Interventional Pulmonary Arterial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Seralutinib, Gereic Dry Powder Inhaler.
Who it may be relevant to
Registry conditions: Pulmonary Arterial Hypertension. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Belgium, Brazil +25
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Overview

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.

Interventions

  • Drug Seralutinib
    Capsule containing seralutinib
  • Device Gereic Dry Powder Inhaler
    Generic dry powder inhaler for seralutinib delivery

Primary outcome measures

  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: From baseline to end of study (up to 48 months or availability of commercial product)]
Secondary outcome measures (2)
  • Changes in distance achieved on the Six-Minute Walk Test (6MWT) [Time frame: 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)]
  • Changes in NT-proBNP [Time frame: 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)]

Eligibility criteria

Inclusion criteria

  • Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
  • 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.
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • 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.
  • 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.
  • 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

  • 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).
  • Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 33 centers
  • Valley Advanced Lung Diseases Institute — Fresno
  • Department of Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles
  • UC Davis Health Medical Center — Sacramento
  • Stanford Healthcare — Stanford
  • University of Florida Health — Gainesville
  • Mayo Clinic Jacksonville — Jacksonville
  • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead — Atlanta
  • The Emory Clinic — Atlanta
  • … and 25 more centers
Germany · 7 centers
  • Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, — Cologne
  • Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat — Dresden
  • Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und — Giessen
  • Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hyp — Heidelberg
  • Klinikum der LMU Medizinische Klinik und Poliklinik V — Munich
  • Krankenhaus Neuwittelsbach — München
  • Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmung — Würzburg
Japan · 7 centers

Center list to be confirmed — check the primary protocol.

Brazil · 6 centers
  • Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa — Belo Horizonte
  • Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di — Blumenau
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS — Porto Alegre
  • Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de — São Paulo
  • Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESP — São Paulo
United Kingdom · 6 centers

Center list to be confirmed — check the primary protocol.

Argentina · 5 centers
  • Cardiologia Palermo — Buenos Aires
  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral — Corrientes
  • Instuto de Investigacion Clinicas Quilmes — Quilmes
  • Instituto Medico Rio Cuarto — Río Cuarto
  • Hospital Provincial Dr. Jose Maria Cullen — Santa Fe
Spain · 5 centers

Center list to be confirmed — check the primary protocol.

Canada · 4 centers
  • Peter Lougheed Center — Calgary
  • London Health Sciences Centre - Victoria Hospital — London
  • University of Ottawa Heart Institute — Ottawa
  • University Health Network, Toronto General Hospital — Toronto
France · 4 centers
  • CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie — Le Kremlin-Bicêtre
  • Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur — Lille
  • CHU de Nice - Hopital Pasteur — Nice
  • CHU de Poitiers — Poitiers
Greece · 4 centers
  • "Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary H — Athens
  • ATTIKON University Hospital, 2nd Critical Care Department — Athens
  • Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department — Kallithea
  • AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic — Thessaloniki
Italy · 4 centers
  • IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC — Bologna
  • Azienda Ospedaliera Dei Colli - Ospedale Monaldi — Naples
  • Fondazione IRCCS Policlinico San Matteo — Pavia
  • … and 1 more center
South Korea · 4 centers

Center list to be confirmed — check the primary protocol.

Australia · 3 centers
  • Pulmonary Hypertension Research Queensland — Auchenflower
  • St Vincent's Hospital (Melbourne) — Fitzroy
  • Royal Hobart Hospital — Hobart
Belgium · 2 centers
  • Hopital Erasme — Anderlecht
  • University Hospitals of Leuven (Campus Gasthuisberg) — Leuven
Chile · 2 centers
  • Centro de Investigacion Clinica UC-CICUC — Santiago
  • Enroll SpA — Santiago
Colombia · 2 centers
  • Fundacion Abood Shaio — Bogotá
  • Fundacion Neumologica Colombiana — Bogotá
Czechia · 2 centers
  • Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenz — Prague
  • Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1. — Prague
Mexico · 2 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 2 centers

Center list to be confirmed — check the primary protocol.

Poland · 2 centers

Center list to be confirmed — check the primary protocol.

Portugal · 2 centers

Center list to be confirmed — check the primary protocol.

Romania · 2 centers

Center list to be confirmed — check the primary protocol.

Saudi Arabia · 2 centers

Center list to be confirmed — check the primary protocol.

Singapore · 2 centers

Center list to be confirmed — check the primary protocol.

Denmark · 1 center
  • Aarhus Universiteshospital — Aarhus
Ireland · 1 center
  • Mater Misericordiae University Hospital — Dublin
Israel · 1 center
  • Lady Davis Carmel Medical Center — Haifa
Latvia · 1 center

Center list to be confirmed — check the primary protocol.

Lithuania · 1 center

Center list to be confirmed — check the primary protocol.

Serbia · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06274801 · GB002-3102 · 2023-506334-75

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗