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A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
EU CTIS ID: 2025-521769-29-00
What this study is testing
To evaluate the safety and tolerability of the long-term use of TPIP in participants with PHILD from Study INS1009-311
- 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
- Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311.
- Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.
You likely can't join if
- Participants who experienced any AEs evaluated as causally related to TPIP by the Investigator in a lead-in study , which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.
- Current use or expected need for PAH-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.
- Pregnant or breastfeeding. Male and female (WOCBP) participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies (contraceptive guidance is located in Section 10.4). Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.4.5 and Section 8.5.5.
- Any medical or psychological condition, including relevant laboratory abnormalities that, in the opinion of the Investigator, may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.
- Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema)
- Evidence of left ventricular failure, HFpEF or postcapillary PH
See the full eligibility criteria
Who can join
- Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311.
- Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.
What rules you out
- Participants who experienced any AEs evaluated as causally related to TPIP by the Investigator in a lead-in study , which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.
- Current use or expected need for PAH-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.
- Pregnant or breastfeeding. Male and female (WOCBP) participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies (contraceptive guidance is located in Section 10.4). Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.4.5 and Section 8.5.5.
- Any medical or psychological condition, including relevant laboratory abnormalities that, in the opinion of the Investigator, may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.
- Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema)
- Evidence of left ventricular failure, HFpEF or postcapillary PH
- Platelet count <50.0 x 103/μL at Enrollment, and/or unexplained coagulation abnormalities in repeated laboratory tests.
- Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- United Kingdom
- Peru
- Brazil
- United States
- Switzerland
- New Zealand
- Georgia
- Australia
- Philippines
- Malaysia
- Serbia
- Colombia
- Argentina
- Turkey
- Taiwan
- Israel
- Korea, Republic of
- Japan
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; United Kingdom; Peru; Brazil; United States; Switzerland and 14 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.