SPI-62 as a treatment for adrenocorticotropic hormone-dependent Cushing's Syndrome (RESCUE)

SPI-62 as a treatment for adrenocorticotropic hormone-dependent Cushing's Syndrome (RESCUE)

ClinicalTrials.gov ID: NCT05307328
Sponsor: Sparrow Pharmaceuticals
Information provided by: Sparrow Pharmaceuticals (Responsible Party)
Last Update Posted: 2024-04-19

Brief Summary:
This is a randomized, placebo-controlled, study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome caused by a non-adrenal tumor. Subjects will receive each of the following 2 treatments for 24 weeks: SPI-62 and matching placebo with the option of long-term extension.

Detailed Description:
This is a multicenter, randomized, placebo-controlled, Phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period (Days -35 to -8), a baseline period (Days -7 to -1), and a treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24) and, the option of long-term extension. Subjects have the option to continue with the study on active study drug and return to the site every 3 months for blood tests and study drug dispensing. The visits may be conducted remotely if testing can be arranged.

Official Title:
SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome

Intervention / Treatment: 
- Drug: SPI-62
- Drug: Placebo

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