BridgeMD
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)
EU CTIS ID: 2023-504904-26-00
What this study is testing
To evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC from baseline to Week 52 in subjects with PPF.
- 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
- Subject gives voluntary informed consent to participate in the study.
- In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
- Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
- Subject has radiological evidence of pulmonary fibrosis of >10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
- Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator: a) Clinically significant decline in % predicted FVC based on ≥10% relative decline b) Marginal decline in % predicted FVC based on ≥5% to <10% relative decline combined with worsening of respiratory symptoms c) Marginal decline in % predicted FVC based on ≥5% to <10% relative decline combined with increasing extent of fibrotic changes on chest imaging d) Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
- FVC ≥45% predicted at Screening (confirmed by central review).
You likely can't join if
- Subject is pregnant or lactating.
- Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
- Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
- Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in noninterventional, observational, or registry studies are eligible.
- Subject has received nerandomilast within 60 days prior to Baseline.
- Acute pulmonary embolism within 90 days prior to Baseline.
See the full eligibility criteria
Who can join
- Subject gives voluntary informed consent to participate in the study.
- In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
- Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
- Subject has radiological evidence of pulmonary fibrosis of >10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
- Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator: a) Clinically significant decline in % predicted FVC based on ≥10% relative decline b) Marginal decline in % predicted FVC based on ≥5% to <10% relative decline combined with worsening of respiratory symptoms c) Marginal decline in % predicted FVC based on ≥5% to <10% relative decline combined with increasing extent of fibrotic changes on chest imaging d) Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
- FVC ≥45% predicted at Screening (confirmed by central review).
- Subjects must be on 1 of the following: a) On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator’s opinion, are planning to continue treatment through the study b) Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator’s opinion, not planning to initiate either treatment during the study. Concomitant use of both nintedanib and pirfenidone is not permitted.
- Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator’s clinical opinion, must be refractory to treatment.
- Women of childbearing potential must be nonpregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and nonlactating, and will agree to do 1 of the following: a) Abstain from intercourse (when it is in line with their preferred and usual lifestyle) b) Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. 1)Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide. Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.
- Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
What rules you out
- Subject is pregnant or lactating.
- Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
- Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
- Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in noninterventional, observational, or registry studies are eligible.
- Subject has received nerandomilast within 60 days prior to Baseline.
- Acute pulmonary embolism within 90 days prior to Baseline.
- In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
- In the opinion of the Investigator, life expectancy <12 months due to ILD or a concomitant illness.
- Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC <0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
- Subject has a diagnosis of IPF.
- Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
- Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5Is), soluble guanylate cyclase stimulators , or activin signaling inhibitors (sotatercept) within 60 days prior to Baseline. As needed use of a PDE5I for erectile dysfunction is permitted, provided no doses are taken within 48 hours prior to any studyrelated efficacy assessments.
- Subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
- Chile
- Taiwan
- Canada
- Korea, Republic of
- New Zealand
- Argentina
- Peru
- Israel
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 United Kingdom; Australia; Chile; Taiwan; Canada; Korea, Republic of and 4 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.