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

A Multicenter, Single-arm, Open-label, Long-term Follow-up Safety Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Drug: Selexipag

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 220036
    • The Republican Scientific-Practical Center ''Cardiology''
  • Minsk, Belarus, 220143
    • Minsk Regional Clinical Hospital
• India
  • Ahmedabad, India, 380015
    • Sanjivani Hospitals
  • Chennai, India, 600006
    • Apollo Hospitals
• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St. Mary'S Hospital
• Romania
  • Bucuresti, Romania, 050152
    • Institutul de pneumoftiziologie Marius Nasta
• Taiwan
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• Ukraine
  • Dnipro, Ukraine
    • Municipal Inst. Of Dnipropetrovsk Region. Council
  • Kharkiv, Ukraine
    • Health Care Municipal Institution City Clinical Hospital #13
  • Kyiv, Ukraine, 03680
    • State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selexipag; Participants will receive selexipag tablets twice daily with the dose strength corresponding to their individual maximum tolerated dose (iMTD) from the parent study.	Drug: Selexipag; Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.; Other Names: JNJ-67896049; ACT-293987

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention.	From Day 1 up to 7 years (end of study)
Frequency of AEs Leading to Premature Discontinuation of Selexipag	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention.	From Day 1 up to 7 years (end of study)
Frequency of Serious Adverse Events (SAEs)	An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product or medically important.	From Day 1 up to 7 years (end of study)
Frequency of Death	Frequency of death will be reported.	From Day 1 up to 7 years (end of study)
Number of Pregnancies with Maternal Exposure to Selexipag	Number of pregnancies with maternal exposure to selexipag will be reported.	From Day 1 up to 7 years (end of study)

Collaborators and Investigators

• Sponsor: Actelion
• Investigators: Study Director: Actelion Clinical Trial, Actelion

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): November 10, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Antihypertensive Agents; Selexipag
• Other Study ID Numbers: CR108892; 2020-000475-21 (EudraCT Number); 67896049PUH3001 (Other Identifier: Actelion)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No