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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LTP001
Placebo
Standard of Care (SoC)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LTP001

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Number of participants with absolute decline of ≥10% predicted in FVC
To assess the incidence of absolute decline in FVC over 10% predicted
Change from baseline to the end of treatment epoch in DLCO
To assess the impact of the investigational products on pulmonary physiology
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
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
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
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
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
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

Full Information

First Posted
August 5, 2022
Last Updated
October 24, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05497284
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
May 26, 2026 (Anticipated)
Study Completion Date
June 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LTP001
Arm Type
Experimental
Arm Description
Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks
Intervention Type
Drug
Intervention Name(s)
LTP001
Intervention Description
LTP001 will be administered once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to LTP001 will be administered once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Standard of Care (SoC)
Intervention Description
nintedanib, pirfenidone, or neither
Primary Outcome Measure Information:
Title
Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted
Description
To assess the efficacy of the investigational products compared to placebo in participants with IPF
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 26
Secondary Outcome Measure Information:
Title
Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC)
Description
To assess the efficacy of the investigational products compared to placebo in participants with IPF
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 26
Title
Time to progression
Description
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
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 26
Title
Number of participants with absolute decline of ≥10% predicted in FVC
Description
To assess the incidence of absolute decline in FVC over 10% predicted
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 26
Title
Change from baseline to the end of treatment epoch in DLCO
Description
To assess the impact of the investigational products on pulmonary physiology
Time Frame
Baseline, Weeks 12 and 26
Title
Change from baseline to the end of treatment epoch in 6-minute walk distance
Description
To assess the impact of the investigational products on exercise capacity
Time Frame
Baseline, Weeks 12 and 26
Title
Change from baseline to the end of treatment epoch in scores from the K-BILD questionnaire
Description
To assess the patient reported impacts of cough of the investigational products compared to placebo in K-Bild Scores
Time Frame
Baseline, Weeks 12 and 26
Title
Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire
Description
To assess the patient reported impacts of cough of the investigational products compared to placebo in Leicester Cough Scores
Time Frame
Baseline, Weeks 12 and 26
Title
Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire
Description
To assess the patient reported impacts IPF on quality of life of the investigational products compared to placebo in R-Scale Scores
Time Frame
Baseline, Weeks 12 and 26
Title
Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts)
Description
To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores
Time Frame
Baseline, Weeks 12 and 26
Title
Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms)
Description
To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores and Symptoms
Time Frame
Baseline, Weeks 12 and 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7330
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ranelagh, Partido De Berazate
State/Province
Buenos Aires
ZIP/Postal Code
1884
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Parana
ZIP/Postal Code
3100
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-044
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90 153
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

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

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