Interstitial Lung Disease, Pulmonary Hypertension
Conditions
Keywords
pulmonary hypertension, interstitial lung disease
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
Interventions
Oral inhalation using a capsule-based dry powder.
DRUGPlacebo
Oral inhalation in initial double-dummy titration period.
Sponsors
Insmed Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380). * Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.
Exclusion criteria
* Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant. * Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed. * Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema). * Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine). Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) | Up to 108 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose | Up to 104 weeks |
| Absolute Change From Baseline in Forced Vital Capacity (FVC) | Up to 104 weeks |
| Percent Change From Baseline in Forced Vital Capacity (FVC) | Up to 104 weeks |
| Absolute Change From Baseline in Percent Predicted FVC (FVC% pred) | Up to 104 weeks |
| Percent Change From Baseline in Percent Predicted FVC (FVC% pred) | Up to 104 weeks |
| Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Up to 104 weeks |
| Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Up to 104 weeks |
| Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%) | Up to 104 weeks |
| Percent Change From Baseline in Percent Predicted FEV1 (FEV1%) | Up to 104 weeks |
| Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) | Up to 104 weeks |
| Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD) | Up to 104 weeks |
| Percentage of Participants With a Clinical Worsening Events | Up to 104 weeks |
| Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score | Up to 104 weeks |
| Mean Change From Baseline in L-PF Cough Domain Score | Up to 104 weeks |
| Mean Change From Baseline in L-PF Dyspnea Domain Score | Up to 104 weeks |
| Mean Change From Baseline in L-PF Impact Domain Score | Up to 104 weeks |
| Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score | Up to 104 weeks |
| Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) | Up to 104 weeks |
| Percentage of Participants With Major Morbidity or Mortality Events | Up to 104 weeks |
Countries
Japan, South Korea, Spain, Taiwan, United States
Contacts
CONTACTInsmed Incorporated
STUDY_DIRECTORStudy Director
Insmed Incorporated
Outcome results
None listed