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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05176951




Registration number
NCT05176951
Ethics application status
Date submitted
10/12/2021
Date registered
4/01/2022
Date last updated
25/03/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Scientific title
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Secondary ID [1] 0 0
2021-003294-66
Secondary ID [2] 0 0
INS1009-211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Treprostinil Palmitil
Treatment: Drugs - Placebo

Experimental: Treprostinil Palmitil - Participants will be administered TPIP once per day at a starting dose of 80 micrograms (µg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 µg and 640 µg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.

Placebo Comparator: Placebo - Participants will be administered a placebo matching TPIP once daily.


Treatment: Drugs: Treprostinil Palmitil
Oral inhalation using a capsule-based dry powder inhaler device.

Treatment: Drugs: Placebo
Oral inhalation using a capsule-based dry powder inhaler device.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to Day 140
Primary outcome [2] 0 0
Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to Day 140
Primary outcome [3] 0 0
Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels
Timepoint [3] 0 0
Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Timepoint [1] 0 0
Day 1 to Week 16
Secondary outcome [2] 0 0
Cmax of Treprostinil
Timepoint [2] 0 0
Day 1 to Week 16
Secondary outcome [3] 0 0
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Timepoint [3] 0 0
Day 1 to Week 16
Secondary outcome [4] 0 0
Tmax of Treprostinil
Timepoint [4] 0 0
Day 1 to Week 16
Secondary outcome [5] 0 0
Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil
Timepoint [5] 0 0
Day 1 to Week 16
Secondary outcome [6] 0 0
AUCtau of Treprostinil
Timepoint [6] 0 0
Day 1 to Week 16
Secondary outcome [7] 0 0
Area Under Concentration-time Curve From 0 to Infinity (AUC8) of Treprostinil Palmitil
Timepoint [7] 0 0
Day 1 to Week 16
Secondary outcome [8] 0 0
AUC8 of Treprostinil
Timepoint [8] 0 0
Day 1 to Week 16
Secondary outcome [9] 0 0
Area Under Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Timepoint [9] 0 0
Day 1 to Week 16
Secondary outcome [10] 0 0
AUClast of Treprostinil
Timepoint [10] 0 0
Day 1 to Week 16
Secondary outcome [11] 0 0
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Timepoint [11] 0 0
Day 1 to Week 16
Secondary outcome [12] 0 0
CL/F of Treprostinil
Timepoint [12] 0 0
Day 1 to Week 16
Secondary outcome [13] 0 0
Elimination Half-life (t1/2) of Treprostinil Palmitil
Timepoint [13] 0 0
Day 1 to Week 16
Secondary outcome [14] 0 0
t1/2 of Treprostinil
Timepoint [14] 0 0
Day 1 to Week 16
Secondary outcome [15] 0 0
Apparent Volume of Distribution After Terminal Phase (Vd/F) of Treprostinil Palmitil
Timepoint [15] 0 0
Day 1 to Week 16
Secondary outcome [16] 0 0
Vd/F of Treprostinil
Timepoint [16] 0 0
Day 1 to Week 16

Eligibility
Key inclusion criteria
- Males and females must be = 18 to = 80 years of age at the time of signing the
informed consent form (ICF).

- Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease
(ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary
fibrosis [IPF], connective tissue disease [CTD], sarcoidosis).

- Male and female participants must use contraceptives that are consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies.

- Male participants:

Male participants who are not sterile, with female partners of childbearing potential, must
be using effective contraception from Day 1 to at least 90 days after the last dose of
study drug.

Male participants with women of child bearing potential (WOCBP) partner must use a condom
in order to avoid potential exposure to embryo/fetus.

- Female participants: Women must be postmenopausal (defined as no menses for 12 months
without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or
bilateral salpingo-oophorectomy) or using highly effective contraception methods (ie,
methods that alone or in combination achieve <1% unintended pregnancy rates per year when
used consistently and correctly) from Day 1 to at least 90 days after the last dose of
study drug.

- Capable of giving signed informed consent that includes compliance with the requirements
and restrictions listed in the ICF and in this protocol.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary diagnosis of chronic obstructive pulmonary disease (COPD).

- Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil
(TRE) or mannitol (an excipient of the TPIP formulation).

- Received or currently treated with riociguat, endothelin receptor antagonists,
selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within
30 days prior to Screening.

- Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, if
already receiving either medication, there is a dose change within 30 days of
Screening Visit.

- Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal
atrial fibrillation), and/or any symptomatic bradycardia.

- History of heart disease including left ventricular ejection fraction (LVEF) = 40% or
clinically significant valvular, constrictive, or symptomatic atherosclerotic heart
disease (eg, stable angina, myocardial infarction, etc).

- Participation in a cardiopulmonary rehabilitation program within 30 days of the first
Screening Visit. Participation in the maintenance program of a cardiopulmonary
rehabilitation program is allowed.

- Acutely decompensated heart failure within 30 days of Screening Visit.

- Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previous
diagnosis of moderate to severe disease, or hospitalization due to COVID-19.

- Supplemental oxygen requirement > 10L/min at rest at Screening.

- Exacerbation of underlying lung disease or active pulmonary or upper respiratory
infection within 30 days of the first dose of study drug (may be rescreened at
appropriate time).

- Current or recent (past 30 days) lower respiratory tract infection (may be rescreened
at appropriate time).

- Any form of congenital heart disease or congenital heart defect (repaired or
unrepaired) other than a patent foramen ovale.

- History of alcohol or drug abuse within 6 months prior to Screening.

- Current use of cigarettes (as defined by Center for Disease Control (CDC)) or
e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime
and who currently smokes either every day or some days.

- Participants who currently inhale marijuana (recreational or medical).

- Acute or chronic impairment (other than dyspnea), limiting the ability to comply with
study requirements, in particular with 6-minute walk test (6MWT) (eg, angina pectoris,
claudication, musculoskeletal disorder, need for walking aids).

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2024
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
AUS003 - Camperdown
Recruitment hospital [2] 0 0
AUS005 - Macquarie Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad Autónoma De BuenosAires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fe
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Germany
State/province [5] 0 0
Baden-Württemberg
Country [6] 0 0
Germany
State/province [6] 0 0
Hessen
Country [7] 0 0
Germany
State/province [7] 0 0
Nordrhein-Westfalen
Country [8] 0 0
Germany
State/province [8] 0 0
Sachsen
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Munich
Country [11] 0 0
Italy
State/province [11] 0 0
Campania
Country [12] 0 0
Italy
State/province [12] 0 0
Lombardia
Country [13] 0 0
Italy
State/province [13] 0 0
Sicilia
Country [14] 0 0
Spain
State/province [14] 0 0
Asturias
Country [15] 0 0
Spain
State/province [15] 0 0
Baleares
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
las Palmas de Gran Canaria
Country [18] 0 0
Spain
State/province [18] 0 0
Santiago de Compostela
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Lanarkshire
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of
treprostinil palmitil inhalation powder (TPIP) compared with placebo
Trial website
https://clinicaltrials.gov/ct2/show/NCT05176951
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries