Clinical trial NCT05497284: To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Official title: A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis


Eligibility criteria: Inclusion Criteria:

* Male and female participants at least 40 years of age
* IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
* FVC ≥45% predicted
* DLCO, corrected for hemoglobin, ≥25% predicted (inclusive)
* Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
* If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization

Exclusion Criteria:

* Airway obstruction (i.e. prebronchodilator FEV1/ FVC \< 0.7) or evidence of a bronchodilator response at screening
* Emphysema \>20% on screening HRCT
* Fibrosis \<10% on screening HRCT
* Clinical diagnosis of any connective tissue disease
* Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization

Additional protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary outcomes:
measure: Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 26
measure: Time to progression
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 26
measure: Number of participants with absolute decline of ≥10% predicted in FVC
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 26
measure: Change from baseline to the end of treatment epoch in DLCO
timeFrame: Baseline, Weeks 12 and 26
measure: Change from baseline to the end of treatment epoch in 6-minute walk distance
timeFrame: Baseline, Weeks 12 and 26
measure: Change from baseline to the end of treatment epoch in scores from the K-BILD questionnaire
timeFrame: Baseline, Weeks 12 and 26
measure: Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire
timeFrame: Baseline, Weeks 12 and 26
measure: Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire
timeFrame: Baseline, Weeks 12 and 26
measure: Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts)
timeFrame: Baseline, Weeks 12 and 26
measure: Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms)
timeFrame: Baseline, Weeks 12 and 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham .
state: Alabama
city: Kansas City
country: United States
facility: University of Kansas Hospital Main Centre
state: Kansas
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ranelagh Partido De Berazate
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Parana
country: Argentina
facility: Novartis Investigative Site
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Chermside
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Spearwood
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
city: Coswig
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Nieuwegein
country: Netherlands
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
Study officials:
References: