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 |
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 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