This study has been transitioned to CTIS with ID 2024-514761-19-00 check the CTIS register for the current data. The primary objective of RIN-PF-303 is to evaluate superiority of inhaled treprostinil against placebo for the annual rate of change in…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the change in absolute FVC in subjects
with IPF from baseline to Week 52.
Safety will be assessed by reviewing the following parameters:
• Adverse events (AEs) and serious adverse events (SAEs)
• Clinical laboratory parameters
• Vital signs, including saturation of peripheral capillary oxygenation (SpO2)
• 12-lead electrocardiograms (ECGs)
Secondary outcome
Secondary efficacy endpoints of the study are:
• Time to clinical worsening (including time to death, respiratory
hospitalization, or >=10% relative decline in % predicted FVC)
• Time to first acute exacerbation of IPF
• Overall survival at Week 52
• Change from baseline in % predicted FVC at Week 52
• Change from baseline in King*s Brief Interstitial Lung Disease Questionnaire
score at Week 52
• Change from baseline in diffusion capacity of lungs for carbon monoxide
(DLCO) at Week 52
Exploratory efficacy endpoints of the study are:
• Change from baseline in absolute FVC at Weeks 16, 28, and 40
• Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
at Week 52
• Change from baseline in resting supplemental oxygen use at Week 52
Background summary
Idiopathic Pulmonary Fibrosis (IPF) is a serious, chronic, progressive,
fibrosing interstitial pneumonia with no known cause typically occurring in
patients above 50 years of age. It is characterized by progressive fibrosis,
lung scarring, and a typical radiological pattern. IPF is associated with
increasing cough and dyspnea, greatly impacts patient quality of life, and
eventually leads to death from respiratory failure or complicating
comorbidities. Currently there is no cure for IPF, and only 2 drugs are
approved to treat the condition (nintedanib and pirfenidone). (protocol 1.1)
Treprostinil belongs to the group of prostacyclins and has a well-characterized
pharmacology. treprostinil is approved for the treatment of pulmonary arterial
hypertension (PAH) following the subcutaneous, intravenous, inhaled (as
treprostinil sodium), or oral (as treprostinil diolamine) routes of
administration. (protocol 1.2.1)
The improvements in FVC and reduced exacerbations of underlying lung disease
from the INCREASE study (RCT), combined with the preclinical evidence of
antifibrotic activity of treprostinil, suggest that inhaled treprostinil may
offer a treatment option for patients with IPF. (protocol 1.3)
This study hypothesizes that inhaled treprostinil will have a positive effect
on absolute FVC after 52 weeks of therapy as compared with placebo when
administered to subjects with IPF. (protocol 1.4)
Study objective
This study has been transitioned to CTIS with ID 2024-514761-19-00 check the CTIS register for the current data.
The primary objective of RIN-PF-303 is to evaluate superiority of inhaled
treprostinil against placebo for the annual rate of change in absolute forced
vital capacity (FVC) from baseline to Week 52.
Study design
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational,
efficacy and safety study of subjects with IPF treated with inhaled
treprostinil over a 52-week period.
Intervention
Daily treatment duirng 52 weeks with inhaled treprostinil or placebo using the
TD-300 ultrasonic nebulizer.
Study burden and risks
Treprostinil has a long history of safety and efficacy in WHO Group 1 PAH and
is currently marketed as 3 formulations (parenteral solution, inhalation
solution, and oral tablet) in various regions. Additionally, the recently
completed INCREASE study (RIN-PH-201) demonstrated
that inhaled treprostinil is safe and efficacious for the treatment of PH-ILD.
The pulmonary function test safety results from INCREASE suggest that inhaled
treprostinil may provide substantial benefit with minimal risks for the
treatment of IPF.
The TD-300/A has been in use since 01 May 2018. Use of the TD-300/A has
resulted in no occasional, probable, or frequent severe ADEs. A further
analysis of the anticipated ADEs resulting from the risk mitigation processes,
which incorporate the TD-300/A post-market use,
can be found in the TD-300/A IB. The potential benefits of the nebulised
treprostinil solution administered with the TD-300/A in IPF subjects discussed
previously, and the minimal observed risk of the TD-300/A after more than 4
million exposure days, suggest the TD-300/A provides substantial benefit with
minimal risks for the treatment of IPF.
P. Smith
Alexander Drive 55 Tw
Durham 27709-0152
United States
+1 9194255431
psmith@unither.com
RP Regulatory Department
Alexander Drive 55 Tw
Durham 27709-0152
United States
+19194255431
rtpregulatory@unither.com
Listed location countries
Age
Inclusion criteria
Eligible subjects must be >=40 years of age at the time of signing informed
consent; have 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 imaging and
if available, surgical lung biopsy; and have a FVC >=45% predicted. Subjects on
pirfenidone or nintedanib must be on a stable and optimized dose for >=30 days
prior to Baseline.
Exclusion criteria
Subjects with forced expiratory volume in 1 second (FEV1)/FVC <0.70, those on
>10 L/min of
supplemental oxygen at rest at Baseline, and women who are pregnant or
lactating will not be eligible to participate in the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82375.100.22 |
| EudraCT | 2021-005881-17 |
| EU-CTR | 2024-514761-19-00 |
| CCMO | NL82375.100.22 |