A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
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| ClinicalTrials.gov Identifier: NCT05176951 |
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Recruitment Status :
Recruiting
First Posted : January 4, 2022
Last Update Posted : March 24, 2023
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Sponsor:
Insmed Incorporated
Information provided by (Responsible Party):
Insmed Incorporated
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Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Hypertension | Drug: Treprostinil Palmitil Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 32 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | December 22, 2022 |
| Estimated Primary Completion Date : | August 31, 2023 |
| Estimated Study Completion Date : | August 31, 2023 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Treprostinil
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Treprostinil Palmitil
Oral inhalation using a capsule-based dry powder inhaler device
Other Name: INS1009 |
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Placebo Comparator: Placebo
Participants will be administered a placebo matching treprostinil palmitil (TPIP) once daily.
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Drug: Placebo
Oral inhalation using a capsule-based dry powder inhaler device. |
Primary Outcome Measures :
- Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 140 ]
- Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs) [ Time Frame: Up to Day 140 ]
- Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels [ Time Frame: Pre-, during, and post- 6-minute walk test (6MWT) at baseline, Week 5, Week 10, and Week 16 ]
Secondary Outcome Measures :
- Maximum plasma concentration (Cmax) of treprostinil palmitil [ Time Frame: Day 1 to week 16 ]
- Cmax of treprostinil [ Time Frame: Day 1 to week 16 ]
- Time to maximum plasma concentration (Tmax) of treprostinil palmitil [ Time Frame: Day 1 to week 16 ]
- Tmax of treprostinil [ Time Frame: Day 1 to week 16 ]
- Area under concentration-time curve from time 0 to 24 hours post-dose (AUC24) of treprostinil palmitil [ Time Frame: Day 1 to week 16 ]
- AUC24 of treprostinil [ Time Frame: Day 1 to week 16 ]
- Apparent total clearance (CL/F) of treprostinil palmitil [ Time Frame: Day 1 to week 16 ]
- CL/F of treprostinil [ Time Frame: Day 1 to week 16 ]
- Elimination half-life (t1/2) of treprostinil palmitil [ Time Frame: Day 1 to week 16 ]
- t1/2 of treprostinil [ Time Frame: Day 1 to week 16 ]
- Apparent volume of distribution after terminal phase (Vd/F) of treprostinil palmitil [ Time Frame: Day 1 to week 16 ]
- Vd/F of treprostinil [ Time Frame: Day 1 to week 16 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females must be ≥ 18 to ≤ 75 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, post-tubal ligation for at least 12 months) 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.
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, endothelial 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.
- Acutely decompensated heart failure within 30 days of Screening Visit.
- Active and current symptomatic COVID-19 and/or previous diagnosis of moderate to severe disease, or hospitalization due to COVID-19.
- Supplemental oxygen requirement > 10L/min 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
- 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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05176951
Contacts
| Contact: Insmed Medical Information | 1-844-446-7633 | medicalinformation@insmed.com |
Locations
Show 41 study locations
Sponsors and Collaborators
Insmed Incorporated
| Responsible Party: | Insmed Incorporated |
| ClinicalTrials.gov Identifier: | NCT05176951 |
| Other Study ID Numbers: |
INS1009-211 2021-003294-66 ( EudraCT Number ) |
| First Posted: | January 4, 2022 Key Record Dates |
| Last Update Posted: | March 24, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Insmed Incorporated:
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Pulmonary Hypertension Interstitial Lung Disease Treprostinil Palmitil |
Additional relevant MeSH terms:
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Lung Diseases Hypertension, Pulmonary Lung Diseases, Interstitial Hypertension Vascular Diseases |
Cardiovascular Diseases Respiratory Tract Diseases Treprostinil Antihypertensive Agents |