Clinical trial · Interventional
SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
NCT05307328CI-TRIAL-00096410RESCUEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cortisol Excess | — | UNRESOLVED | — |
| Cortisol; Hypersecretion | — | UNRESOLVED | — |
| Cortisol Overproduction | — | UNRESOLVED | — |
| Cushing Disease Due to Increased ACTH Secretion | — | UNRESOLVED | — |
| Cushing's Syndrome I | — | UNRESOLVED | — |
| Ectopic ACTH Secretion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| SPI-62 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPI-62
- description
- Active drug by mouth each morning for up to 12 weeks
- interventionNames
- Drug: SPI-62
- Drug: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo by mouth each morning for up to 12 weeks
- interventionNames
- Drug: SPI-62
- Drug: Placebo
Primary outcomes (1)
- measure
- Change from baseline in urinary HSD-1 ratio
- timeFrame
- Baseline to 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or non-menstruating female * 18 years or older * Active and consistent cortisol excess * Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing's disease, ectopic ACTH secretion, and ectopic CRH secretion. Exclusion Criteria: * Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization. * History of any fractionated radiation therapy for Cushing's within the past 2 years or conventional radiation therapy within 4 years. * History of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-ACTH-dependent Cushing's syndrome (including certain inherited conditions). * High risk of acute morbidity from corticotroph adenoma growth (similar to that which occurs with Nelson's syndrome) defined as current evidence of macroadenoma at risk of impingement of vital structures. * Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results, including but not limited to poor venous access or recent receipt or donation of blood products. * Women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence.
References
Publications (0)
Data not yet available
No reference posted for this study.