A Phase III Study of Osilodrostat to Treat Cushing’s Disease

CLCI699C2302: A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study with an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients with Cushing’s Disease

Purpose

In people with a disorder known as Cushing’s disease, levels of the hormone cortisol are very high in the urine and blood. Lowering cortisol levels relieves the symptoms of Cushing’s disease. Osilodrostat is an investigational drug that inhibits an enzyme needed for cortisol to be made.

In this study, researchers are assessing the safety and effectiveness of osilodrostat in patients with Cushing¿s disease and observing its ability to reduce cortisol levels. In the first 12 weeks of the study, patients will receive osilodrostat or a placebo (inactive drug). After week 12 and continuing through week 48, all patients will receive osilodrostat. Patients will then have the option to continue taking osilodrostat for up to 100 weeks into the study, if they wish.

Osilodrostat is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have Cushing¿s disease with elevated levels of cortisol in the urine.
  • An acceptable amount of time must have passed between the completion of prior therapies and entry into the study, to allow for a sufficient “washout” period.
  • This study is for patients ages 18 to 75.

For more information about this study and to inquire about eligibility, please contact Dr. Eliza Geer at 646-888-2627.

Protocol

17-351

Phase

III

Investigator

Co-Investigators

Diseases

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