SPI-62 for Cushing's Syndrome

(RESCUE Trial)

Recruiting at 26 trial locations

Overseen By Frank Czerwiec, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sparrow Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Frank Czerwiec, MD

Principal Investigator

Sparrow Pharmaceuticals ([e-mail])

Eligibility Criteria

This trial is for adults over 18 with ACTH-dependent Cushing's syndrome not caused by an adrenal tumor. Participants must have consistent cortisol excess and a confirmed diagnosis. They can't join if they've had recent Cushing's surgery, are at risk of tumor growth complications, have conditions that could affect the study, are pregnant or not using contraception, or have had certain past treatments for Cushing's.

Inclusion Criteria

You have ongoing high levels of cortisol in your body.

I am 18 years old or older.

I have been diagnosed with ACTH-dependent Cushing's syndrome.

Exclusion Criteria

I don't have any health issues that would affect this study's process or results.

I have had or will have surgery for Cushing's disease within 6 months.

I have a history of specific adrenal gland surgery or rare forms of Cushing's syndrome.

Treatment Details

Interventions

• Placebo (Other)
• SPI-62 (Other)

Trial Overview The study tests SPI-62 against a placebo in patients with ACTH-dependent Cushing's syndrome. Each participant will receive both SPI-62 and a placebo for 24 weeks each, with an option to continue longer. The assignment to either SPI-62 or placebo is random.

Participant Groups

Group I: SPI-62 Experimental Treatment 2 Interventions

Active drug by mouth each morning for up to 12 weeks

Group II: Placebo Placebo Group 2 Interventions

Placebo by mouth each morning for up to 12 weeks

Who Is Running the Clinical Trial?

Sparrow Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

160+