Phase 3 Pulmonary Hypertension Trial, Recruiting NCT07179380 Sponsor: Insmed Incorporated Condition: Pulmonary Hypertension
Back to Pulmonary Hypertension

Phase 3 Pulmonary Hypertension Trial, Recruiting

NCT07179380
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with pulmonary hypertension (high blood pressure in the lungs) related to a scarring lung disease, such as idiopathic interstitial pneumonia, chronic hypersensitivity pneumonitis, connective tissue disease-associated lung disease, or combined pulmonary fibrosis and emphysema.
  • A CT scan (a detailed X-ray of the lungs) has confirmed you have a fibrotic (scarring) lung disease, either at screening or within the past 12 months.
  • A procedure called a right heart catheterization has confirmed your pulmonary hypertension, showing specific pressure and resistance readings in your lungs, either at screening or within the past 12 months (confirm with trial site for exact values).
  • You are able to walk between 100 and 500 meters in a 6-minute walking test, with two tests done at least 4 hours apart giving similar results.
  • If you are already taking long-term medicines for your condition (such as anti-scarring drugs, immune system medicines, or certain blood pressure medications), you have been on them for at least 90 days and at the same dose for at least 30 days before screening.
  • You are able to understand and sign a consent form agreeing to take part in the trial.

Who may not be able to join:

  • You have a different type of pulmonary hypertension not caused by scarring lung disease (WHO Groups 1, 2, 4, or 5, or other Group 3 subtypes).
  • Your main diagnosis is chronic obstructive pulmonary disease (COPD), or breathing tests show a specific pattern associated with COPD (confirm with trial site).
  • You have significant heart problems on the left side of your heart, such as serious valve disease, weak heart pumping, a certain type of heart failure, signs of pressure coming from the left heart affecting the lungs, unstable angina, or uncontrolled irregular heartbeat.
  • You have evidence of blood clots in the lung arteries (chronic thromboembolic disease), or you have had a sudden lung blood clot within the past 6 months.
  • You have a known allergy or medical reason why you cannot take the study drug (treprostinil/TPIP) or its ingredients, such as mannitol or leucine.
  • You currently smoke cigarettes or use e-cigarettes regularly or occasionally, and have smoked at least 100 cigarettes in your lifetime.
  • You have used inhaled marijuana (for any reason) at least once in the past 30 days, or expect to use it during the study.
  • You have any other medical or mental health condition that, in the doctor's opinion, could put you at risk, affect your ability to complete the trial, or make the results harder to interpret (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 18444467633

Australian sites

AUS001, Camperdown, New South Wales
AUS006, Kingswood, New South Wales
AUS005, New Lambton Heights, New South Wales
AUS003, Westmead, New South Wales

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Insmed Incorporated
Registry
ClinicalTrials.gov
Start date
7 January 2026
Est. completion
30 December 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇳🇿 New Zealand 🇵🇹 Portugal 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change in 6MWD Measured at Peak Exposure From Baseline to Week 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov