To navigate the following site navigation expect to utilize the tab key to move through items sequentially. The spacebar or enter keys can be utilized to interact with items that open sub-navigation.
When autocomplete results are available use up and down arrows to review and enter to select.
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Study Purpose
The primary objective of this study is to evaluate the safety and tolerability of the
long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and
other lead-in studies of TPIP in participants with PH-ILD.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Participants who completed the end of treatment visit in Study INS1009-211
(NCT05176951).
Participants for whom the OLE study was not available at the time of
their completion of the lead-in study are eligible for enrolment within one year of
their lead-in end of treatment visit.
- Complete baseline screening assessments to confirm eligibility to participate if more
than 30 days have elapsed since the end of the study visit in Study INS1009-211, or
any other lead-in PH-ILD TPIP study.
- Capable of giving signed informed consent that includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.
Exclusion Criteria:
- Participants who experienced any hypersensitivity or adverse drug reaction or were
withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of
the Investigator, could indicate that continued treatment with TPIP may present an
unreasonable risk for the participant.
- Initiation of parenteral administration of prostacyclin analogues (eg, TRE,
epoprostenol) since the completion of Study INS1009-211 or other TPIP studies.
Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost) and oral
prostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg, selexipag) are
permitted if stopped 24 hours prior to the start of study drug administration.
Pregnant or breastfeeding. Male and female participants must use contraceptives that are
consistent with local regulations regarding the methods of contraception for those
participating in clinical studies. Female participants of childbearing potential must have
a negative urine pregnancy test result at trial entry before the first dose of study drug.
- Any medical or psychological condition, including relevant laboratory abnormalities at
screening that, in the opinion of the Investigator, suggest a new and/or insufficiently
understood disease that may present an unreasonable risk to the study participant as a
result of participation in the study.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2/Phase 3
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Insmed Incorporated
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Argentina, Australia, Belgium, Germany, Italy, Spain, United Kingdom
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Participants who are not transitioning immediately from INS1009-211 and other lead-in studies, will be administered TPIP, once daily (QD), during 3-week titration period.
Participants who are transitioning immediately from a randomized blinded lead-in TPIP study and who previously received:
TPIP- will be administered placebo QD along with the maximum tolerated dose (MTS) TPIP dose from lead-in study in a blinded manner during 3-week titration period.
Placebo- will be administered TPIP QD along with the achieved placebo dose from lead-in study in a blinded manner during 3-week titration period.
The overall treatment period will be 24 months.
Interventions
Drug: - Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Drug: - Placebo
Oral placebo inhalation using a capsule-based dry powder inhaler device.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
ARG003, Autonomus City Of Buenos Aires, Buenos Aires, Argentina
Status
Recruiting
Address
ARG003
Autonomus City Of Buenos Aires, Buenos Aires, C1280AEB
