Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02180217 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease
A Phase 3 study of Cushing's Disease, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 137
- Enrollment target
- 20
- Study locations
NCT02180217: Completed Phase 3 study of Cushing's Disease, sponsored by Novartis Pharmaceuticals.
NCT02180217 is a Phase 3 study of Cushing's Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 137 participants, above the 104-participant average among 5 other Cushing's Disease trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02180217, a Phase 3 study of Cushing's Disease, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 137 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU. This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.
Primary Outcome
To compare the complete response rate at the end of the 8-week period of randomized withdrawal between randomized patients.A primary efficacy responder is defined as a randomized patient who has mUFC ≤ ULN at Week 34 and who was neither discontinued (study or RW treatment) nor had osilodrostat dose increase above the level at Week 26 during the RW Period of the study. mUFC: mean urinary free cortisol; ULN: Upper Limit of Normal
Conditions Studied
Interventions
- DRUG osilodrostat
- DRUG LCI699 matching placebo
Study Locations (20)
New York
- Mount Sinai School of Medicine SC - LCI699C2301 - New York
- Columbia University Medical Center New York Presbyterian SC - LCI699C2301 - New York
- Memorial Sloan Kettering Cancer Center - New York
Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - CABA
Other
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Sofia
Quebec
- Novartis Investigative Site - Montreal
- Novartis Investigative Site - Sherbrooke
Colorado
- University of Colorado Hospital SC - LCI699C2301 - Aurora
Georgia
- Emory University School of Medicine G2304 - C2301 - Atlanta
Illinois
- Northwestern University SC - LCI699C2301 - Chicago
Maryland
- The Johns Hopkins University School of Medicine Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2014-10-06 |
| Est. Completion | 2019-12-04 |
| Phase | Phase 3 |
What the finished NCT02180217 record still lists
NCT02180217 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, above the 104-participant average among 5 other Cushing's Disease trials with a reported enrollment target (32% higher).
The record links to 1 condition, with Cushing's Disease appearing as the primary indexed condition, and to 2 interventions - of which osilodrostat is the first listed.
NCT02180217 names 20 study sites across 15 states, led by New York, Buenos Aires, Other.
Frequently Asked Questions
What is clinical trial NCT02180217 about?
NCT02180217 is a clinical study titled "Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease". The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU. This is a phase lll, multi-center, do...
What is the current status of trial NCT02180217?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2014-10-06. Estimated completion is 2019-12-04.
What conditions does trial NCT02180217 study?
This clinical trial studies the following conditions: Cushing's Disease.
What interventions are being tested in trial NCT02180217?
The interventions under investigation include: osilodrostat (DRUG), LCI699 matching placebo (DRUG).
Who is sponsoring clinical trial NCT02180217?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02180217 being conducted?
This trial has 20 study locations across Colorado, Georgia, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cushing's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease
COMPLETED · Phase 3
-
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
RECRUITING
-
DDAVP for Pituitary Adenoma
RECRUITING · NA
-
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
RECRUITING · Phase 2
-
Safety and Efficacy of LCI699 in Cushing's Disease Patients
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05091424 · 137 participants · Phase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
- NCT05655182 · 137 participants · Phase 1
A Study of BLB-201 RSV Vaccine in Infants and Children
- NCT06571669 · 137 participants · NA
BOOM-IBD2 Pivotal Clinical Trial
- NCT06644768 · 137 participants · Phase 1
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI