To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497284
• Other study ID #: CADPT09A12201
• Status: Recruiting
• Phase: Phase 2
• Start date: November 10, 2022
• Est. completion date: November 22, 2024

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: November 22, 2024
• Est. primary completion date: November 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• LTP001
LTP001 will be administered once daily in the morning
• Placebo
Placebo to LTP001 will be administered once daily in the morning
• Standard of Care (SoC)
nintedanib, pirfenidone, or neither

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Parana
Argentina	Novartis Investigative Site	Ranelagh, Partido De Berazate	Buenos Aires
Australia	Novartis Investigative Site	Camperdown	New South Wales
Australia	Novartis Investigative Site	Chermside	Queensland
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Spearwood	Western Australia
Australia	Novartis Investigative Site	Westmead	New South Wales
Czechia	Novartis Investigative Site	Praha 4
Germany	Novartis Investigative Site	Coswig
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Muenchen
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Nieuwegein
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Lodz
United States	University of Alabama at Birmingham .	Birmingham	Alabama
United States	Inova Fairfax Hosp Inst of Rsrch	Falls Church	Virginia
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Vanderbilt Unversity Medical Center .	Nashville	Tennessee
United States	University of Washington Med Ctr .	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Czechia,  Germany,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted	To assess the efficacy of the investigational products compared to placebo in participants with IPF	Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary	Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC)	To assess the efficacy of the investigational products compared to placebo in participants with IPF	Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary	Time to progression	Time to progression as defined by a composite endpoint including any of the following events; Absolute reduction from baseline of =10% predicted in FVC, Nonelective hospitalization for respiratory events, Lung Transplant, Death	Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary	Number of participants with absolute decline of =10% predicted in FVC	To assess the incidence of absolute decline in FVC over 10% predicted	Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary	Change from baseline to the end of treatment epoch in DLCO	To assess the impact of the investigational products on pulmonary physiology	Baseline, Weeks 12 and 26
Secondary	Change from baseline to the end of treatment epoch in 6-minute walk distance	To assess the impact of the investigational products on exercise capacity	Baseline, Weeks 12 and 26
Secondary	Change from baseline to the end of treatment epoch in scores from the K-BILD questionnaire	To assess the patient reported impacts of cough of the investigational products compared to placebo in K-Bild Scores	Baseline, Weeks 12 and 26
Secondary	Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire	To assess the patient reported impacts of cough of the investigational products compared to placebo in Leicester Cough Scores	Baseline, Weeks 12 and 26
Secondary	Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire	To assess the patient reported impacts IPF on quality of life of the investigational products compared to placebo in R-Scale Scores	Baseline, Weeks 12 and 26
Secondary	Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts)	To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores	Baseline, Weeks 12 and 26
Secondary	Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms)	To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores and Symptoms	Baseline, Weeks 12 and 26