Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05255991




Registration number
NCT05255991
Ethics application status
Date submitted
15/02/2022
Date registered
25/02/2022
Date last updated
27/08/2024

Titles & IDs
Public title
Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2)
Secondary ID [1] 0 0
2021-005881-17
Secondary ID [2] 0 0
RIN-PF-303
Universal Trial Number (UTN)
Trial acronym
TETON-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Inhaled Treprostinil
Treatment: Devices - Treprostinil Ultrasonic Nebulizer

Placebo comparator: Placebo - Matching placebo inhaled using an ultrasonic nebulizer QID

Experimental: Inhaled Treprostinil - Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.


Treatment: Drugs: Placebo
Placebo administered QID

Treatment: Drugs: Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered QID

Treatment: Devices: Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Absolute FVC from Baseline to Week 52
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Time to Clinical Worsening
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Time to First Acute Exacerbation of IPF
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Overall Survival at Week 52
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Change in % Predicted FVC from Baseline to Week 52
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Change in K-BILD Questionnaire Score from Baseline to Week 52
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Change in DLCO from Baseline to Week 52
Timepoint [6] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
1. Subject gives voluntary informed consent to participate in the study.
2. Subject is =40 years of age, inclusive, at the time of signing informed consent.
3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution computed tomography (HRCT) (performed within the previous 12 months), and if available, surgical lung biopsy.
4. FVC =45% predicted at Screening.
5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for =30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted.
6. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
7. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
8. 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is pregnant or lactating.
2. Subject has primary obstructive airway physiology: FEV1/FVC <0.70 at Screening.
3. The 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.
4. The 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 (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours of any study-related efficacy assessments.
5. Use of any of the following medications: azathioprine (AZA), cyclosporine, mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the combination of OCS+AZA+N-acetylcysteine within 30 days prior to Baseline; cyclophosphamide within 60 days prior to Baseline; or rituximab within 6 months prior to Baseline.
6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
7. Exacerbation of IPF 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 IPF or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
9. 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.
10. 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 non-interventional, observational, or registry studies are eligible.
11. Life expectancy <6 months due to IPF or a concomitant illness.
12. Acute pulmonary embolism within 90 days prior to Baseline.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
Accrual to date
Final
597
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital, Missenden Road - Camperdown
Recruitment hospital [2] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [3] 0 0
Westmead Hospital, Corner of Hawkesbury and Darcy Road - Westmead
Recruitment hospital [4] 0 0
Cairns Hospital - Cairns
Recruitment hospital [5] 0 0
Lung Research Qld - Chermside
Recruitment hospital [6] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [7] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [8] 0 0
Respiratory Clinical Trials Pty Ltd - Kent Town
Recruitment hospital [9] 0 0
Alfred Health - Melbourne
Recruitment hospital [10] 0 0
Austin Health - Melbourne
Recruitment hospital [11] 0 0
Institute for Respiratory Health - Midland - Nedlands
Recruitment hospital [12] 0 0
Institute for Respiratory Health - Nedlands - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
5067 - Kent Town
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Cordoba
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Argentina
State/province [4] 0 0
Tucuman
Country [5] 0 0
Argentina
State/province [5] 0 0
Mendoza
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Namur
Country [8] 0 0
Belgium
State/province [8] 0 0
Aalst
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Chile
State/province [12] 0 0
Maule
Country [13] 0 0
Chile
State/province [13] 0 0
Region Metropolitana
Country [14] 0 0
Chile
State/province [14] 0 0
Región Metropolitana
Country [15] 0 0
Chile
State/province [15] 0 0
Valparaiso
Country [16] 0 0
Denmark
State/province [16] 0 0
Aarhus N
Country [17] 0 0
Denmark
State/province [17] 0 0
Hellerup
Country [18] 0 0
Denmark
State/province [18] 0 0
Odense C
Country [19] 0 0
France
State/province [19] 0 0
Ille-et-Vilaine
Country [20] 0 0
France
State/province [20] 0 0
Seine-Saint Denis
Country [21] 0 0
France
State/province [21] 0 0
Amiens Cedex 1
Country [22] 0 0
France
State/province [22] 0 0
Caen
Country [23] 0 0
France
State/province [23] 0 0
Lyon
Country [24] 0 0
France
State/province [24] 0 0
Marseille
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Reims Cedex
Country [27] 0 0
France
State/province [27] 0 0
Rouen
Country [28] 0 0
France
State/province [28] 0 0
Toulouse Cedex 9
Country [29] 0 0
France
State/province [29] 0 0
TOURS Cedex 9
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-Württemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Bayern
Country [32] 0 0
Germany
State/province [32] 0 0
Nordrhein-Westfalen
Country [33] 0 0
Germany
State/province [33] 0 0
Bad Berka
Country [34] 0 0
Germany
State/province [34] 0 0
Coswig
Country [35] 0 0
Germany
State/province [35] 0 0
München
Country [36] 0 0
Israel
State/province [36] 0 0
HaDarom
Country [37] 0 0
Israel
State/province [37] 0 0
HaMerkaz
Country [38] 0 0
Israel
State/province [38] 0 0
Tel-Aviv
Country [39] 0 0
Israel
State/province [39] 0 0
Yerushalayim
Country [40] 0 0
Israel
State/province [40] 0 0
Hadera
Country [41] 0 0
Israel
State/province [41] 0 0
Haifa
Country [42] 0 0
Israel
State/province [42] 0 0
Petah Tiqva
Country [43] 0 0
Italy
State/province [43] 0 0
Emilia-Romagna
Country [44] 0 0
Italy
State/province [44] 0 0
Lombardia
Country [45] 0 0
Italy
State/province [45] 0 0
Sicilia
Country [46] 0 0
Italy
State/province [46] 0 0
Toscana
Country [47] 0 0
Italy
State/province [47] 0 0
Ancona
Country [48] 0 0
Italy
State/province [48] 0 0
Modena
Country [49] 0 0
Italy
State/province [49] 0 0
Roma
Country [50] 0 0
Italy
State/province [50] 0 0
Rome
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Gyeonggido
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Seoul Teugbyeolsi
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Incheon
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Mexico
State/province [55] 0 0
Nuevo León
Country [56] 0 0
Mexico
State/province [56] 0 0
Ciudad de México
Country [57] 0 0
Netherlands
State/province [57] 0 0
Limburg
Country [58] 0 0
Netherlands
State/province [58] 0 0
Utrecht
Country [59] 0 0
Netherlands
State/province [59] 0 0
Zuid-Holland
Country [60] 0 0
New Zealand
State/province [60] 0 0
Canterbury
Country [61] 0 0
New Zealand
State/province [61] 0 0
Waikato
Country [62] 0 0
Peru
State/province [62] 0 0
Cusco
Country [63] 0 0
Peru
State/province [63] 0 0
Lima
Country [64] 0 0
Spain
State/province [64] 0 0
Asturias
Country [65] 0 0
Spain
State/province [65] 0 0
Barcelona
Country [66] 0 0
Spain
State/province [66] 0 0
Islas Baleares
Country [67] 0 0
Spain
State/province [67] 0 0
Granada
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Murcia
Country [70] 0 0
Spain
State/province [70] 0 0
Santander
Country [71] 0 0
Spain
State/province [71] 0 0
Santiago de Compostela
Country [72] 0 0
Taiwan
State/province [72] 0 0
Samin District
Country [73] 0 0
Taiwan
State/province [73] 0 0
Kaohsiung
Country [74] 0 0
Taiwan
State/province [74] 0 0
New Taipei City
Country [75] 0 0
Taiwan
State/province [75] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
United Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
United Therapeutics Global Medical Information
Address 0 0
Country 0 0
Phone 0 0
919-485-8350
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05255991