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

NCT05497284 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CADPT09A12201
• Study Type: interventional
• Target: 46
• Locations: 7 countries
• Sites: 15

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

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis; FVC; DLCO; 6-minute walk test; patient reported outcome; HRCT

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted

  Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. It is expressed as percent predicted, defined as FVC of the participant divided by the average FVC in the population for any person of similar age, sex, and body composition multiplied by 100. A positive change from baseline is considered a favorable outcome.

  Baseline, up to approximately 26 weeks

Secondary Outcomes (9)

• Change From Baseline to End of Treatment Epoch in FVC

  Baseline, up to approximately 26 weeks

• Progression-free Survival (PFS)

  Baseline, up to approximately 26 weeks

• Number of Participants With Absolute Decline of ≥10% Predicted in FVC

  Baseline, up to approximately 26 weeks

• Change From Baseline to the End of Treatment Epoch in Diffusion Capacity of Lung for Carbon Monoxide (DLCO)

  Baseline, up to approximately 26 weeks

• Change From Baseline to the End of Treatment Epoch in 6-minute Walk Distance (6MWD)

  Baseline, up to approximately 26 weeks

Study Arms (2)

LTP001

EXPERIMENTAL

LTP001 orally once daily in the morning for approximately 26 weeks.

Drug: LTP001; Drug: Standard of Care (SoC)

Placebo

EXPERIMENTAL

Placebo orally once daily in the morning for approximately 26 weeks.

Drug: Placebo; Drug: Standard of Care (SoC)

Interventions

LTP001 DRUG

LTP001 administered once daily in the morning

LTP001

Placebo DRUG

Placebo to LTP001 administered once daily in the morning

Placebo

Standard of Care (SoC) DRUG

nintedanib, pirfenidone, or neither

LTP001; Placebo

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Novartis Investigative Site

CABA, Buenos Aires, C1056ABJ, Argentina

Location

Novartis Investigative Site

Ranelagh Partido de Berazate, Buenos Aires, 1884, Argentina

Location

Novartis Investigative Site

Paraná, 3100, Argentina

Location

Novartis Investigative Site

Camperdown, New South Wales, 2050, Australia

Location

Novartis Investigative Site

Chermside, Queensland, 4032, Australia

Location

Novartis Investigative Site

Spearwood, Western Australia, 6163, Australia

Location

Novartis Investigative Site

Prague, 140 59, Czechia

Location

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

Location

Novartis Investigative Site

Coswig, 01640, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Novartis Investigative Site

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Novartis Investigative Site

Bialystok, 15-044, Poland

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+ 1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 11, 2022
• Study Start: November 10, 2022
• Primary Completion: August 26, 2024
• Study Completion: September 26, 2024
• Last Updated: January 13, 2026
• Results First Posted: September 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

AR (3); CZ (1); NL (2); DE (3); US (2); AU (3); PL (1)