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An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension
EU CTIS ID: 2023-509305-68-00
What this study is testing
To evaluate the long-term safety and tolerability of ralinepag (APD811) in subjects who participated in a preceding Phase 2 or Phase 3 study of ralinepag.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
- Subjects who are willing and able to comply with scheduled clinic visits, treatment plans, laboratory tests, and other study procedures.
- Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
- Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through the 30-Day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (ie, actively attempt to become pregnant or to impregnate, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of ralinepag.
You likely can't join if
- Subjects who prematurely discontinued ralinepag due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol-defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study.
- Subjects who withdrew consent during participation in another ralinepag study.
- Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit).
- Women who are pregnant, lactating, or breastfeeding
- Subjects who have undergone lung or heart/lung transplant or the initiation of long-term (>12 weeks) parenteral (intravenous or subcutaneous infusion) or inhaled therapy with a prostacyclin or oral therapy with another IP receptor agonist during the time since participation in their original ralinepag study.
- Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.
See the full eligibility criteria
- Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
- Subjects who are willing and able to comply with scheduled clinic visits, treatment plans, laboratory tests, and other study procedures.
- Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
- Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through the 30-Day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (ie, actively attempt to become pregnant or to impregnate, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of ralinepag.
- Subjects who prematurely discontinued ralinepag due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol-defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study.
- Subjects who withdrew consent during participation in another ralinepag study.
- Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit).
- Women who are pregnant, lactating, or breastfeeding
- Subjects who have undergone lung or heart/lung transplant or the initiation of long-term (>12 weeks) parenteral (intravenous or subcutaneous infusion) or inhaled therapy with a prostacyclin or oral therapy with another IP receptor agonist during the time since participation in their original ralinepag study.
- Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.
- Known hypersensitivity to ralinepag or any of the excipients.
- Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study, eg, noncompliance concerns, any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Taiwan
- United States
- Australia
- Singapore
- China
- Israel
- Serbia
- Mexico
- Brazil
- Canada
- United Kingdom
- Argentina
- Chile
- Ukraine
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Taiwan; United States; Australia; Singapore; China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.