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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05497284




Registration number
NCT05497284
Ethics application status
Date submitted
5/08/2022
Date registered
11/08/2022
Date last updated
25/06/2024

Titles & IDs
Public title
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Scientific 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
Secondary ID [1] 0 0
CADPT09A12201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LTP001
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of Care (SoC)

Experimental: LTP001 - Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks

Experimental: Placebo - Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks


Treatment: Drugs: LTP001
LTP001 will be administered once daily in the morning

Treatment: Drugs: Placebo
Placebo to LTP001 will be administered once daily in the morning

Treatment: Drugs: Standard of Care (SoC)
nintedanib, pirfenidone, or neither
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary outcome [1] 0 0
Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC)
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary outcome [2] 0 0
Time to progression
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary outcome [3] 0 0
Number of participants with absolute decline of =10% predicted in FVC
Timepoint [3] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary outcome [4] 0 0
Change from baseline to the end of treatment epoch in DLCO
Timepoint [4] 0 0
Baseline, Weeks 12 and 26
Secondary outcome [5] 0 0
Change from baseline to the end of treatment epoch in 6-minute walk distance
Timepoint [5] 0 0
Baseline, Weeks 12 and 26
Secondary outcome [6] 0 0
Change from baseline to the end of treatment epoch in scores from the K-BILD questionnaire
Timepoint [6] 0 0
Baseline, Weeks 12 and 26
Secondary outcome [7] 0 0
Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire
Timepoint [7] 0 0
Baseline, Weeks 12 and 26
Secondary outcome [8] 0 0
Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire
Timepoint [8] 0 0
Baseline, Weeks 12 and 26
Secondary outcome [9] 0 0
Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts)
Timepoint [9] 0 0
Baseline, Weeks 12 and 26
Secondary outcome [10] 0 0
Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms)
Timepoint [10] 0 0
Baseline, Weeks 12 and 26

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/08/2024
Actual
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [3] 0 0
Novartis Investigative Site - Chermside
Recruitment hospital [4] 0 0
Novartis Investigative Site - Spearwood
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Parana
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha 4
Country [9] 0 0
Germany
State/province [9] 0 0
Coswig
Country [10] 0 0
Germany
State/province [10] 0 0
Essen
Country [11] 0 0
Germany
State/province [11] 0 0
Muenchen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Amsterdam
Country [13] 0 0
Netherlands
State/province [13] 0 0
Nieuwegein
Country [14] 0 0
Poland
State/province [14] 0 0
Bialystok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT05497284
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries