Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
1 other identifier
interventional
125
10 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
Longer than P75 for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2018
CompletedStudy Start
First participant enrolled
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 21, 2026
April 1, 2026
8.6 years
May 1, 2018
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term safety of relacorilant
Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
36 months
Other Outcomes (6)
Long-term benefit of relacorilant
36 months
Long-term benefit of relacorilant
36 months
Long-term benefit of relacorilant
36 months
- +3 more other outcomes
Study Arms (1)
relacorilant (CORT125134)
EXPERIMENTALInterventions
CORT125134 is supplied as capsules for oral dosing.
Eligibility Criteria
You may qualify if:
- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
- According to the Investigator's opinion will benefit from continuing treatment with relacorilant
You may not qualify if:
- Premature discontinuation from a relacorilant parent study.
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has Stage ≥ 4 renal failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Site 49
Phoenix, Arizona, 85013, United States
Site 35
Stanford, California, 94305, United States
Site 39
Torrance, California, 90502, United States
Site 50
Miami, Florida, 33136, United States
Site 10
Atlanta, Georgia, 30318, United States
Site 9
Chicago, Illinois, 60611, United States
Site 1
Indianapolis, Indiana, 46202, United States
Site 5
Metairie, Louisiana, 70006, United States
Site 27
Baltimore, Maryland, 21287, United States
Site 13
Fall River, Massachusetts, 02721, United States
Site 8
Ann Arbor, Michigan, 48109, United States
Site 36
Rochester, Minnesota, 55905, United States
Site 34
Jackson, Mississippi, 39202, United States
Site 3
St Louis, Missouri, 63110, United States
Site 55
Reno, Nevada, 89511, United States
Site 6
Albany, New York, 12206, United States
Site 24
New York, New York, 10021, United States
Site 4
Wilmington, North Carolina, 28401, United States
Site 43
Cleveland, Ohio, 44195, United States
Site 2
Pittsburgh, Pennsylvania, 15212, United States
Site 46
Pittsburgh, Pennsylvania, 15213, United States
Site 11
Dallas, Texas, 75390, United States
Site 7
El Paso, Texas, 79935, United States
Site 32
Fort Worth, Texas, 76132, United States
Site 12
Houston, Texas, 77079, United States
Site 14
Vienna, 1090, Austria
Site 51
Nova Scotia, Canada
Site 16
Munich, Germany
Site 42
Würzburg, 97080, Germany
Site 20
Ramat Gan, 5265601, Israel
Site 29
Tel Aviv, 64239, Israel
Site 40
Ancona, 60126, Italy
Site 44
Messina, 98125, Italy
Site 25
Milan, 20145, Italy
Site 21
Naples, 80131, Italy
Site 48
Padova, 35128, Italy
Site 52
Torino, Italy
Site 33
Rotterdam, 3015 GD, Netherlands
Site 47
Krakow, 30-688, Poland
Site 45
Lublin, 20412, Poland
Site 37
Bucharest, 050474, Romania
Site 31
Bucharest, 10825, Romania
Site 28
Bucharest, 11863, Romania
Site 53
Alicante, Spain
Site 18
Girona, Spain
Site 17
Madrid, 28007, Spain
Site 38
Málaga, 29006, Spain
Site 19
Seville, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying Ru, MD, PhD
Corcept Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2018
First Posted
July 27, 2018
Study Start
May 7, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share