SERALUTINIB for Pulmonary arterial hypertension

Inclusion criteria

• {"criterion_text":"- 1. Subjects must have completed a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.\n- 2. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at Enrollment visit before first administration of seralutinib. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required, and results must be negative.\n- 3. 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 seralutinib; acceptable methods include hormonal contraception (oral contraceptives – provided stable dose, patch, implant, or injection), intrauterine devices, or other form of highly effective contraception. Female subjects must refrain from egg donation throughout this period.\n- 4. Women of nonchildbearing potential (WONCBP), classified by one of the following: a. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation, Falope® rings, clips, or bands; segmental destruction of the fallopian tubes with electrocoagulation; suture ligation, a microinsert such as the Essure® system, or hysterectomy). b. Evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and have luteinizing hormone (LH), follicle stimulating hormone (FSH), and estradiol levels in the post-menopausal range at the Enrollment visit.\n- 5. 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 seralutinib. Male subjects must refrain from sperm donation throughout this period.\n- 6. 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.\n- 7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures."}

Exclusion criteria

• {"criterion_text":"- 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 MM (or designee).\n- 2. Have any other condition or reason that, in the opinion of the Investigator would prohibit the subject from participating in the study."}

Primary endpoints

• {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1. Changes in distance achieved on the six-minute walk test (6MWT), (Δ6MWD)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. Changes in NT-proBNP","definition_or_measurement_approach":""}

Primary sponsor

Full Name

GB002 Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Global Ltd.

Responsibilities

12

Name

PPD Romania S.R.L.

Responsibilities

1, 12

Name

PPD Development LP

Responsibilities

1,12,13,2,4,5,6

Name

WCG Clinical Inc.

Responsibilities

15 (Study Coordinator provision & website)

Name

Fisher Clinical Services Inc.

Responsibilities

14

Name

Medidata Solutions Inc.

Responsibilities

7

Third parties

• {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"sponsorDuties codes: 12","organisation_type":"Pharmaceutical company"}
• {"country":"Romania","full_name":"PPD Romania S.R.L.","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: 15 (Study Coordinator provision & website)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"United Biosource LLC","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"sponsorDuties codes: 15 (Patient Travel France Only)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Professional Case Management Clinical Trials LLC","duties_or_roles":"sponsorDuties codes: 15 (Home Health Care)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: 15 (Patient Travel & Subject Reimbursement)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Olink Proteomics Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"FluidDa","duties_or_roles":"sponsorDuties codes: 15 (High-resolution computer tomography)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,12,13,2,4,5,6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}