Clinical Trial: SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome (RESCUE)

[~MaryO~]

Brief Summary:

This is a randomized, placebo-controlled, crossover study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo

 

Condition or disease	Intervention/treatment	Phase
Cushing's Syndrome ICushing Disease Due to Increased ACTH Secretion Cortisol ExcessCortisol; Hypersecretion Cortisol Overproduction Ectopic ACTH Secretion	Drug: SPI-62 Drug: Placebo	Phase 2

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 3 periods: a 28-day screening period (Days -35 to -8), a 7-day baseline period (Days -7 to -1), and a 24-week treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24). Up to 26 subjects will be enrolled with the aim that 18 subjects with Cushing's disease will complete the study. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo.

Study Design

 

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Study Type  :	Interventional  (Clinical Trial)
Estimated Enrollment  :	26 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Intervention Model Description:	Staggered parallel crossover
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
Actual Study Start Date  :	March 1, 2022
Estimated Primary Completion Date  :	March 15, 2023
Estimated Study Completion Date  :	August 15, 2023

 

More info at https://clinicaltrials.gov/ct2/show/record/NCT05307328