This study has been transitioned to CTIS with ID 2023-509305-68-00 check the CTIS register for the current data. To evaluate the long-term safety and tolerability of ralinepag (ADP811) in subjects who participated in a preceding Phase 2 or Phase 3…
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy assessments will include an evaluation of:
• N-terminal pro b-type natriuretic peptide (NT-proBNP)
• 6-minute walk distance (6MWD)
• WHO/NYHA functional class
• The proportion of subjects who achieve all 3 of the following (at
specified time points):
* NT-proBNP level <300 pg/mL
* 6MWD >440 meters
* WHO/NYHA FC II status or better
• HRQoL measures (where validated)
• Time to all-cause hospitalization during the study period
• Time to all-cause mortality during the study period
Secondary outcome
N/A
Background summary
PAH results from the small arteries (blood vessels) in your lungs becoming
narrow or blocked. These narrow or blocked blood vessels make it harder for the
blood to flow, which can cause the blood pressure in your lungs to increase and
means that the heart will need to work harder to pump the blood to the lungs.
Eventually, this can lead to a decreased function of your heart (heart
failure).
Ralinepag, the investigational study drug, is designed to activate the
prostacyclin receptor (a protein found on cells of blood vessels to which a
naturally occurring substance called prostacyclin attach). In patients with
PAH, reduced activity of the prostacyclin receptors can cause the blood vessels
in the lungs to become narrow, making it harder for the blood to flow. By
increasing the activity of prostacyclin receptors, it is anticipated that
ralinepag may improve blood flow to the lungs, which may improve symptoms of
PAH (shortness of breath while exercising, dizziness, high blood pressure).
Study objective
This study has been transitioned to CTIS with ID 2023-509305-68-00 check the CTIS register for the current data.
To evaluate the long-term safety and tolerability of ralinepag (ADP811) in
subjects who participated in a preceding Phase 2 or Phase 3 study of ralinepag.
Study design
The APD811-303 study is a multicenter, open-label extension (OLE) study for
subjects with WHO Group 1 PAH who have participated in another Phase 2 or Phase
3 study of ralinepag and who qualify for entry based upon participation in the
prior study.
Intervention
Treatment with ralinepag will continue for up to 6 years or until the subject
either prematurely discontinues treatment due to an AE/SAE or other reason,
marketing approval of ralinepag is granted in the region in which the study is
conducted, or the study is discontinued by the Sponsor.
Study burden and risks
The measurements of PAH-symptoms will be repeated more often than during SoC
and Subject will need to visit the hospital more often.
T.W. Alexander Drive 55
Research Triangle Park NC 27709
US
T.W. Alexander Drive 55
Research Triangle Park NC 27709
US
Listed location countries
Age
Inclusion criteria
Each subject must meet ALL of the following inclusion criteria to be eligible
for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document
indicating that the subject has been informed of all pertinent aspects of the
study prior to initiation of any study-related procedures.
2. Subjects who are willing and able to comply with scheduled visits, treatment
plan, laboratory tests, and other study procedures.
3. Completed the protocol-defined Study Drug Termination Visit or End of Study
Visit procedures in the preceding ralinepag study.
4. 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 (i.e., actively attempt to become pregnant or to impregnate, sperm
donation, in vitro fertilization) during the study and for 30 days after the
last dose of ralinepag.
Exclusion criteria
Eligible subjects must not meet ANY of the following exclusion criteria to be
eligible for enrollment into the study:
1. Subjects who prematurely discontinued investigational medicinal product
(IMP) 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.
2. Subjects who withdrew consent during participation in another ralinepag
study.
3. Female subjects who wish to become pregnant or who have a positive pregnancy
test on Day 1 (OLE Entry Visit).
4. Women who are pregnant, lactating or breast-feeding
5. Subjects who have undergone lung or heart/lung transplant or are receiving
longterm parenteral (intravenous [i.v.] infusion or subcutaneous infusion) or
inhaled therapy with a prostacyclin or oral therapy with another IP receptor
agonist (selexipag) during the time since participation in their original
ralinepag study.
6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF)
>450 msec and female subjects with QTcF > 470 msec on electrocardiogram (ECG)
recorded within 12 weeks prior to Day 1.
7. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3
ralinepag study.
8. Known hypersensitivity to ralinepag or any of the excipients.
9. Any reason that, in the opinion of the investigator or medical monitor,
precludes the subject from participating in the study, e.g., non-compliance
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-509305-68-00 |
| EudraCT | EUCTR2018-001189-40-NL |
| Other | IND 109021 |
| CCMO | NL67366.029.18 |