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

Pulmonary Arterial Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06274801
• Other study ID #: GB002-3102
• Secondary ID: 2023-506334-75
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Gossamer Bio Inc.
• Contact: GB002 Inc.
• Phone: 1-866-668-4083
• Email: ClinicalTrials[@]gossamerbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects must have completed 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 or his/her legal representative, 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 pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP).

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.

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 or in the opinion of the Sponsor's MM (or designee) in consultation with the Investigator, would prohibit the subject from participating in the study.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Seralutinib
Capsule containing seralutinib

Device:
• Gereic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib delivery

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Pulmonary Associates of Richmond, Inc.	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
GB002, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)		From baseline to end of study (up to 48 months or availability of commercial product)
Secondary	Changes in distance achieved on the Six-Minute Walk Test (6MWT)	?6MWT from Baseline to End of Study	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)
Secondary	Changes in NT-proBNP	Change in NT-proBNP from Baseline to End of Study	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)