A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

NCT04565990 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CR1088922020-000475-2167896049PUH3001
• Study Type: interventional
• Target: 43
• Locations: 6 countries
• Sites: 13

Brief Summary

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.

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days. Data includes all TEAEs irrespective of whether they were serious or non-serious.

  From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

• Number of Participants With TEAEs Leading to Premature Discontinuation of Selexipag

  Number of participants with TEAEs leading to premature discontinuation of selexipag were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days.

  From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

• Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

  Number of participants with TESAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TESAEs were defined as TSAEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days.

  From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

• Number of Participants With Treatment-emergent Deaths

  Number of participants with treatment-emergent deaths during the study were reported.

  From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

• Number of Pregnant Females With Maternal Exposure to Selexipag

  Number of pregnant females with maternal exposure to selexipag were reported.

  From Day 1 up to 30 days after last dose of drug (up to 29 months)

Study Arms (1)

Selexipag

EXPERIMENTAL

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

Interventions

Selexipag DRUG

Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.

Also known as: JNJ-67896049, ACT-293987

Selexipag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (13)

The Republican Scientific-Practical Center ''Cardiology''

Minsk, 220036, Belarus

Location

Minsk Regional Clinical Hospital

Minsk, 220143, Belarus

Location

Sanjivani Hospitals

Ahmedabad, 380015, India

Location

Apollo Hospitals

Chennai, 600006, India

Location

Institutul de pneumoftiziologie Marius Nasta

Bucharest, 050152, Romania

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Municipal Inst. Of Dnipropetrovsk Region. Council

Dnipro, Ukraine

Location

Health Care Municipal Institution City Clinical Hospital #13

Kharkiv, Ukraine

Location

State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

Kyiv, 03680, Ukraine

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

selexipag

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Executive Medical Director CP
• Organization: Actelion Pharmaceuticals Ltd

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Actelion Clinical Trial

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: May 3, 2021
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: May 1, 2025
• Results First Posted: November 20, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (2); RO (1); BE (2); UA (3); IN (2); KR (3)