Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis (STOP-IPF)
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- STATUS
- Recruiting
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- End date
- Jun 30, 2023
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- participants needed
- 100
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- sponsor
- National Jewish Health
Summary
Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have recently 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
Description
This is a double blind, randomized, placebo-controlled, single-dose, three-site trial. The trial is a biomarker-based, integrated Phase 1b/2a clinical trial involving 100 subjects. One group (n=50) will receive placebo, while the other group (n=50) will receive 125 mg of oral saracatinib once daily.
Randomization will be stratified by center. The randomization scheme will be in random blocks of 2 and 4 within each stratum to maintain balance. The study is designed to have interim analysis of the drop-out rates when approximately 30% of the randomized patients have achieved the 24-week assessment. Should the drop-out rate be higher than the 20% that is anticipated, a new sample size calculation will be performed to make sure that the power of the study is maintained at 80% .
Duration of follow-up will be 28 weeks including 24 weeks of treatment with saracatinib or placebo.
Details
| Condition | Idiopathic Pulmonary Fibrosis (IPF) |
|---|---|
| Treatment | Placebo, Saracatinab |
| Clinical Study Identifier | NCT04598919 |
| Sponsor | National Jewish Health |
| Last Modified on | 24 April 2022 |
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