An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Corcept Therapeutics
- Enrollment
- 125
- Locations
- 82
- Primary Endpoint
- Long-term safety of relacorilant
Study Overview
Brief Summary
This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.
Detailed Description
This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.
Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.
Study Design
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single group
- Primary Purpose
- Treatment
- Masking
- None (open label)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Major Inclusion Criteria:
- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome
- According to the Investigator's opinion will benefit from continuing treatment with relacorilant.
Exclusion Criteria
- Major Exclusion Criteria:
- Premature discontinuation from a relacorilant parent study
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
Arms & Interventions
relacorilant (CORT125134)
Intervention: relacorilant (Drug)
Outcomes
Primary Outcomes
Long-term safety of relacorilant
Time Frame: 36 months
Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (82)
Identifiers
- NCT ID
- NCT03604198
- Other Study IDs
- CORT125134-452, 2024-514079-17-00
Dates
- First Submitted
- (8 years ago)
- First Posted
- (8 years ago)
- Primary Completion
- (in 2 months)
- Study Completion
- (in 2 months)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- Yes
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No
