Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis

Summary

Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have been approved for treating PF of unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of patients stop taking the prescribed drug within a year because of side effects. The study includes the use of saracatinib, an investigational drug originally developed to treat certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial.

The objectives of this study are to: i) evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and to explore the efficacy of saracatinib in IPF; ii) identify biomarkers of Src kinase activity and fibrogenesis linked to pulmonary fibrosis; and iii) explore the application of these biomarkers to assess the anti-fibrotic effect of saracatinib in IPF patients

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

DRUG

Saracatinab

125 mg once daily by mouth for 24 weeks

DRUG

Placebo

once daily by mouth for 24 weeks

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• AstraZeneca

  collaborator INDUSTRY

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Baylor University

  collaborator OTHER

• International Center for Health Outcomes and Innovation Research

  collaborator OTHER

• National Jewish Health

  lead OTHER

Principal Investigators

• Gregory Downey, MD · National Jewish Health

• Maria Padilla, MD · Icahn School of Medicine at Mount Sinai

• Danielle Antin-Ozerkis, MD · Yale University

• Susan Mathai, MD · Baylor University Medical Center (BUMC)

• Annetine Gelijns, PhD · Data and Clinical Coordinating Center- InCHOIR

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-12

Primary Completion

2024-09-15

Completion

2025-06-30

FDA Drug

Yes

Countries

• United States

Study Locations