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

Part of paid clinical trials in Fresno, California.

Sponsor
Gossamer Bio USA, Inc.
Study ID
NCT06274801
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Seralutinib — DRUG
    Capsule containing seralutinib
  • Gereic Dry Powder Inhaler — DEVICE
    Generic dry powder inhaler for seralutinib delivery

Study Details

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

Key Dates

First listed
Feb 23, 2024
Start date
Sep 3, 2024
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
330 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Seralutinib 90 mg
    Seralutinib inhaled orally twice per day (BID)

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From baseline to end of study (up to 48 months or availability of commercial product) ]

Central Contacts

Locations (33)

FacilityCityStateZIPSite coordinators
Valley Advanced Lung Diseases InstituteFresnoCalifornia93720-
Department of Veterans Affairs Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
UC Davis Health Medical CenterSacramentoCalifornia95817-
Stanford HealthcareStanfordCalifornia94305-
University of Florida HealthGainesvilleFlorida32610-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Northside Hospital - AtlantaAtlantaGeorgia30342-
Piedmont Physicians Pulmonary & Sleep Medicine of BuckheadAtlantaGeorgia30309-
The Emory ClinicAtlantaGeorgia30322-
UI Health HospitalChicagoIllinois60612-
University of Kansas Medical CenterKansas CityKansas66160-
Norton Pulmonary SpecialistsLouisvilleKentucky40202-
University of MichiganAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
University of New Mexico Health Sciences CenterAlbuquerqueNew Mexico87131-
NYU Langone HealthNew YorkNew York10016-
University of Rochester Medical CenterRochesterNew York14642-
UNC HospitalsChapel HillNorth Carolina27514-
University of Cincinnati Medical CenterCincinnatiOhio45219-
INTEGRIS Cardiovascular PhysiciansOklahoma CityOklahoma73112-
Temple Heart and Vascular Institute (Outpatient Clinic)PhiladelphiaPennsylvania19140-
The Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMC Presbyterian HospitalPittsburghPennsylvania15213-
Medical University of South Carolina - Nexus Research CenterCharlestonSouth Carolina29425-
UT Southwestern Medical CenterDallasTexas75390-
CHI St. Luke's Health Baylor College of Medicine Medical CenterHoustonTexas77030-
Houston Methodist Outpatient CenterHoustonTexas77030-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
Intermountain Medical CenterMurrayUtah84107-
University of Utah HospitalSalt Lake CityUtah84132-
Inova Fairfax Medical CampusFalls ChurchVirginia22042-
Pulmonary Associates of Richmond, Inc.RichmondVirginia23230-

Find similar trials in Fresno, CA

By research site
Valley Advanced Lung Diseases Institute· Fresno, CADepartment of Veterans Affairs Greater Los Angeles Healthcare System· Los Angeles, CAUC Davis Health Medical Center· Sacramento, CAStanford Healthcare· Stanford, CAUniversity of Florida Health· Gainesville, FLMayo Clinic Jacksonville· Jacksonville, FL

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