SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome — RESCUE  

Cortisol; Hypersecretion Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Adrenocortical Hyperfunction
• Cortisol Overproduction
• Cortisol; Hypersecretion
• Cushing Syndrome
• Pituitary ACTH Hypersecretion
• Syndrome

• NCT number: NCT05307328
• Study type: Interventional
• Source: Sparrow Pharmaceuticals
• Contact: Frank Czerwiec, MD
• Phone: +1-617-465-0328
• Email: fczerwiec@sparrowpharma.com
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Completion date: December 1, 2025