Clinical trial · Interventional
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
A Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's Disease
NCT02468193CI-TRIAL-00044970completedPhase 2Results postedClinicalTrials.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)
The study aim was to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.
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 |
|---|---|---|---|
| Adrenal Adenoma | Adrenal Cortical Adenoma | ALIAS | 0.90 |
| Adrenal Carcinoma | — | UNRESOLVED | — |
| AIMAH | — | UNRESOLVED | — |
| Cushing's Syndrome | — | UNRESOLVED | — |
| Ectopic Corticotropin Syndrome | — | UNRESOLVED | — |
| PPNAD | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Osilodrostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Osilodrostat
- description
- Patients in this arm took the study drug, osilodrostat.
- interventionNames
- Drug: Osilodrostat
Primary outcomes (1)
- measure
- Percent Change in the Mean Urine Free Cortisol (mUFC) at the Individual Level at Week 12
- timeFrame
- Baseline, 12 weeks
- description
- Percent change from baseline in the mUFC at the individual patient level
Secondary outcomes (36)
- measure
- Percent Change From Baseline in the mUFC at Individual Patient Level at Week 24 (Day 169) and Week 48 (Day 337)
- timeFrame
- Baseline, Week 24 (day 169) and Week 48 (day 337)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed Cushing's syndrome \[i.e. ectopic corticotropin syndrome, adrenal adenoma, adrenal carcinoma, ACTH-Independent Macronodular Adrenal Hyperplasia (AIMAH), or Primary Pigmented Nodular Adrenal Dysplasia (PPNAD)\] * For patients on medical treatment for hypercortisolism due to Cushing's syndrome, the washout periods had to be completed prior to baseline efficacy assessments Exclusion Criteria: * Patients with Cushing's disease * History of hypersensitivity to osilodrostat or to drugs of similar chemical classes * History of malignancy of any organ system, treated or untreated, within the past 5 years * Patients receiving treatment for within 4 weeks or ≤5 x half-life of the agent (whichever is longer) before first dose of osilodrostat * Patients with risk factors for QTc prolongation or Torsade de Pointes
References
Publications (0)
Data not yet available
No reference posted for this study.