Sarcoidosis, Pulmonary Clinical Trial
Official title:
A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis
This is a multicenter, single-arm, unblinded/open-label study of the effect size of HRCT endpoints in response to glucocorticoid induction therapy in subjects with a diagnosis of pulmonary sarcoidosis who have not received glucocorticoid as initial sarcoidosis therapy (≥ 20 mg/day prednisone or prednisolone) or other sarcoidosis therapy for at least 3 months prior to enrollment. This study will enroll a total of approximately 24 subjects.
Optimal development of novel treatments for sarcoidosis requires clinical study endpoints
that efficiently reflect changes in disease activity over short treatment durations. Such
endpoints enable preliminary assessment of candidate drug efficacy in small studies - prior
to exposing large cohorts to experimental compounds in pursuit of registrational data.
This study will accordingly investigate the ways that certain HRCT-based functional
respiratory imaging (FRI) measures can serve as more quantitative and sensitive endpoints
compared to pulmonary function tests to measure drug effect in a short duration small sample
size study in patients with pulmonary sarcoidosis. The study is designed to minimize impact
on sarcoid care that the patient would have otherwise received. Glucocorticoid (≥ 30 mg/day
prednisone or prednisolone) as per local clinical practice of sarcoidosis initial induction
therapy will be taken orally in this study. The glucocorticoid dose may be modified depending
on ongoing assessment as a part of standard local clinical practice.
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