drugset / Trial / NCT07668895

Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis

NCT07668895

Phase 2/3 Not yet recruiting 126 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn whether a study drug called Compound Betamethasone (also known as Diprospan) works to treat pulmonary sarcoidosis in people with early-stage disease (stage I or II). It will also learn about its safety compared to the standard treatment, prednisone. The main questions it aims to answer are: * How much does the study drug improve lung function (measured by a test called FVC%) after 24 weeks of treatment? * How does it compare to prednisone in controlling symptoms, reducing chest lymph node swelling, and preventing relapse? Researchers will compare Compound Betamethasone injections (given once every 4 weeks) to prednisone pills (taken daily with a gradual dose reduction). Participants will: * Receive either the study drug injection or prednisone pills for 24 weeks * Visit the clinic for checkups and lung function tests at weeks 6, 12, and 24 * Have chest CT scans and blood tests to monitor their condition and any side effects * Be followed up for additional 24 weeks (up to week 48) to see if the disease comes back after treatment stops

Timeline

Start
2026-07
Primary completion
2027-07
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject BETAMETHASONE DIPROPIONATE Small molecule 1 ml Intramuscular
Comparator Prednisone Other / unclassified 40 mg Oral

Indications