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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05497284

CADPT09A12201

Details and patient eligibility

About

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

Full description

This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.

Enrollment: 46 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

LTP001

Experimental group

Description:

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

Treatment:

Drug: LTP001

Drug: Standard of Care (SoC)

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Standard of Care (SoC)