Back to resultsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Primary Purpose
Cushing Syndrome
Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
relacorilant
Sponsored by
About this trial
This is an interventional treatment trial for Cushing Syndrome focused on measuring Cushing Syndrome, Cushing Disease, Cushing, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenal Corticotrophic Hormone (ACTH), Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Moon Facies, Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol
Eligibility Criteria
Inclusion Criteria:
Major Inclusion Criteria:
- 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
Exclusion Criteria:
Major Exclusion Criteria:
- Premature discontinuation from a relacorilant parent study.
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has Stage ≥ 4 renal failure
Sites / Locations
- Site 49
- Site 35
- Site 39
- Site 50
- Site 10
- Site 9
- Site 1
- Site 5
- Site 27
- Site 13
- Site 8
- Site 36
- Site 34
- Site 6
- Site 24
- Site 4
- Site 43
- Site 41
- Site 30
- Site 46
- Site 11
- Site 7
- Site 32
- Site 12
- Site 26
- Site 14
- Site 15
- Site 16
- Site 42
- Site 20
- Site 29
- Site 40
- Site 44
- Site 25
- Site 21
- Site 48
- Site 23
- Site 22
- Site 33
- Site 47
- Site 45
- Site 28
- Site 37
- Site 31
- Site 18
- Site 17
- Site 38
- Site 19
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
relacorilant (CORT125134)
Arm Description
Outcomes
Primary Outcome Measures
Long-term safety of relacorilant
Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03604198
Brief Title
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Official Title
An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing Syndrome
Keywords
Cushing Syndrome, Cushing Disease, Cushing, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenal Corticotrophic Hormone (ACTH), Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Moon Facies, Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
relacorilant (CORT125134)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
relacorilant
Other Intervention Name(s)
CORT125134
Intervention Description
CORT125134 is supplied as capsules for oral dosing.
Primary Outcome Measure Information:
Title
Long-term safety of relacorilant
Description
Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Long-term benefit of relacorilant
Description
Changes from Baseline as measured by glycated hemoglobin(HbA1c) and insulin resistance in patients with diabetes mellitus (DM) or glucose intolerance at Baseline in the parent study
Time Frame
36 months
Title
Long-term benefit of relacorilant
Description
Changes from Baseline as measured by systolic and diastolic blood pressure (BP) by ambulatory BP measurements (ABPM) in patients with uncontrolled hypertension (HTN) at Baseline in the parent study and in patients with controlled HTN taking at least one anti-HTN medication.
Time Frame
36 months
Title
Long-term benefit of relacorilant
Description
Changes from Baseline in weight as measured by Kg
Time Frame
36 months
Title
Long-term benefit of relacorilant
Description
Changes from Baseline in waist circumference measured in cm
Time Frame
36 months
Title
Long-term benefit of relacorilant
Description
Changes from Baselinein quality-of-life based on Cushing quality of life questionnaire 0 (worst) to 100 (best)
Time Frame
36 months
Title
Long-term benefit of relacorilant
Description
Changes from Baseline in hypthalamic-pituitary-adrenal (HPA) axis markers (Plasma ACTH and Fasting Cortisol) and Sex steroid hormone (testosterone and estradiol)
Time Frame
36 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major Inclusion Criteria:
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
Exclusion Criteria:
Major Exclusion Criteria:
Premature discontinuation from a relacorilant parent study.
Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
Has poorly controlled hypertension
Has Stage ≥ 4 renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas G Moraitis, MD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 49
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Site 35
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Site 39
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site 50
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site 10
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Site 9
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Site 1
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Site 5
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Site 27
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Site 13
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Site 8
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Site 36
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Site 34
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Site 6
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Site 24
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Site 4
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Site 43
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site 41
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Site 30
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Site 46
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Site 11
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Site 7
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Site 32
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Site 12
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Site 26
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Site 14
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site 15
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Site 16
City
Munich
Country
Germany
Facility Name
Site 42
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Site 20
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Site 29
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Site 40
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Site 44
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Site 25
City
Milano
ZIP/Postal Code
20145
Country
Italy
Facility Name
Site 21
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Site 48
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Site 23
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Site 22
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Site 33
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Site 47
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Site 45
City
Lublin
ZIP/Postal Code
20412
Country
Poland
Facility Name
Site 28
City
Bucharest
ZIP/Postal Code
11863
Country
Romania
Facility Name
Site 37
City
Bucuresti
ZIP/Postal Code
050474
Country
Romania
Facility Name
Site 31
City
Bucuresti
ZIP/Postal Code
10825
Country
Romania
Facility Name
Site 18
City
Girona
Country
Spain
Facility Name
Site 17
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Site 38
City
Málaga
ZIP/Postal Code
29006
Country
Spain
Facility Name
Site 19
City
Sevilla
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
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