SPI-62 for Cushing's Syndrome (RESCUE Trial)

Palo Alto (17 mi)

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.

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

I am 18 years old or older.

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

I am a man or a woman who does not have periods.

Exclusion Criteria

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.

I have not had radiation for Cushing's in the last 2 or 4 years.

I am not pregnant, breastfeeding, or planning to become pregnant and agree to use birth control or abstain.

My tumor is large and may press on important body parts.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SPI-62Experimental Treatment2 Interventions

Active drug by mouth each morning for up to 12 weeks

Group II: PlaceboPlacebo Group2 Interventions

Placebo by mouth each morning for up to 12 weeks