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Clinical trial

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome (GRACE)

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Last updated:16th Oct 2018
Identifier: NCT03697109

Brief Summary:
This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the safety and efficacy of relacorilant in patients with endogenous Cushing syndrome and concurrent 1) Type 2 diabetes mellitus/impaired glucose tolerance and/or 2) uncontrolled hypertension

Detailed Description:
This Phase 3 study involves two phases, an open-label (OL) phase and a randomized-withdrawal (RW) phase. Patients will dose-escalate in 100 mg increments to a target dose of 400 mg orally once daily during the open-label phase. Patients will remain on open-label treatment until week 22 at which time they will be evaluated for the randomized-withdrawal phase based on pre-defined hyperglycemia and hypertension response criteria. Eligible patients will then be randomized to receive either relacorilant or placebo at a 1:1 ratio for 12 weeks. Patients who do not meet the criteria for randomization will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the randomized-withdrawal phase of the study may also be eligible to roll over into an extension study.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant
Actual Study Start Date: October 16, 2018
Estimated Primary Completion Date: December 2020
Estimated Study Completion Date: January 2021


Arms:
- Experimental:
Relacorilant (open-label phase)
- Experimental: Relacorilant (randomized-withdrawal phase)
- Placebo Comparator: Placebo (randomized-withdrawal phase)

Category Value
Date last updated at source 2019-02-22
Study type(s) Interventional
Expected enrolment 130
Study start date 2018-10-16
Estimated primary completion date 2020-12-01

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