A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study (SOMBRERO)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hypertension, Pulmonary

Treatments: Drug: Selexipag

Study type: Interventional

Funder types: Industry

Identifiers

NCT04565990

67896049PUH3001 (Other Identifier)

2020-000475-21 (EudraCT Number)

CR108892

Details and patient eligibility

About

The purpose of this study is to assess the long-term safety of selexipag while providing continued selexipag treatment for participants who were previously enrolled in an Actelion-sponsored study with selexipag and who derived benefit from selexipag in indications for which a positive benefit-risk has been established.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated with selexipag at the end of a parent study and: a) the parent study has established efficacy with a favorable benefit/risk profile for the indication under investigation; b) participant may continue to benefit from treatment with selexipag; c) has completed the end of treatment (EOT) visit of the parent study; d) no alternative means of access to selexipag have been identified
• Women of childbearing potential must use an acceptable method of contraception throughout the study and until at least 1 month following the last dose of study intervention
• Women of childbearing potential must have a negative urine (or serum if applicable) pregnancy test at screening on Day 1 or at the last visit of the parent study
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion criteria

• Suspected or known pulmonary veno-occlusive disease
• Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
• Interruption of study intervention for more than 14 days since the last dose of study intervention taken in the parent study
• Female participant being pregnant, or breastfeeding, or planning to become pregnant at the time of screening and while enrolled in this study
• Uncontrolled thyroid disease
• Known and documented severe hepatic impairment, example, Child-Pugh Class C
• Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention: a) treatment with a strong CYP 2C8 inhibitor (example, gemfibrozil); b) treatment with oral prostacyclin analogs (example, beraprost, treprostinil) since the last dose of study intervention taken in the parent study; c) any investigational treatment other than selexipag
• Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure if not under close medical supervision, severe arrhythmia, cerebrovascular events (example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Selexipag

Experimental group

Description:

Participants will receive selexipag tablets twice daily with the dose strength corresponding to their individual maximum tolerated dose (iMTD) from the parent study.

Treatment:

Drug: Selexipag