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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

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
Stopped early
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
Actual
26/09/2024
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 - Chermside
Recruitment hospital [3] 0 0
Novartis Investigative Site - Spearwood
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 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
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Parana
Country [5] 0 0
Czechia
State/province [5] 0 0
Praha 4
Country [6] 0 0
Germany
State/province [6] 0 0
Coswig
Country [7] 0 0
Germany
State/province [7] 0 0
Essen
Country [8] 0 0
Germany
State/province [8] 0 0
Muenchen
Country [9] 0 0
Netherlands
State/province [9] 0 0
Groningen
Country [10] 0 0
Netherlands
State/province [10] 0 0
Nieuwegein
Country [11] 0 0
Poland
State/province [11] 0 0
Bialystok

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05497284