EUCTR2018-003096-35-ES进行中（未招募）1 期
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 - GRACE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •To enroll in the study, each patient must meet the following key inclusion criteria:
- •1. Male or female, 18 to 80 years of age, inclusive
- •2. Has a confirmed biochemical diagnosis of endogenous Cushing syndrome based on the presence of at least 2 of the following:
- •UFC above the upper limit of normal (ULN) (50.0 µg/24 hours) in at least 2 complete 24-hour tests within 3 weeks prior to Baseline
- •Late-night salivary cortisol >ULN in at least 2 tests (using a salivette) within 3 weeks prior to Baseline
- •Lack of cortisol suppression (>1.8 µg/dL serum cortisol) on either 1-mg overnight or 2-mg 48-hour dexamethasone suppression testing during Screening, or within 12 weeks before signing the informed consent
- •3. Has at least 2 of the following clinical signs and symptoms of Cushing syndrome:
- •Bodily characteristics of a Cushingoid appearance (e.g., facial rubor, moon facies, dorsocervical fat pad, supraclavicular fat pad)
- •Increased body weight or central obesity
- •Proximal muscle weakness
- •Low bone mass based on DXA scan
- •Psychiatric symptoms (including depression or psychosis)
- •Skin manifestations: violaceous striae, acne, and/or hirsutism
- •Easy bruisability
- •4. Has at least 1 of the following at Baseline:
- •DM (fasting plasma glucose =126 mg/dL and/or 2-hour oGTT plasma glucose =200 mg/dL at 2 hours), or IGT (plasma glucose =140 mg/dL and <200 mg/dL on a 2-hour oGTT) glucose
- •Uncontrolled hypertension (mean SBP =135 to =170 mm Hg and/or mean DBP =85 to =110 mm Hg) based on 24-hour ABPM
- •5. If receiving medical treatment for DM/IGT or hypertension, is on a stable dose of medication for at least 4 weeks prior to Baseline
- •6. If receiving medical treatment for depression, is on a stable dose of medication for at least 6 weeks prior to Baseline
- •7. If female, has a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Patients who meet any of the following criteria will not be permitted entry to the study:
- •1. Has severe, uncontrolled hypertension (mean SBP >170 mm Hg or mean DBP >110 mg at Screening), based on 24-hour ABPM
- •2. Has poorly controlled DM (HbA1c >12% at Screening)
- •3. Has abnormal liver test results (total bilirubin >1.5×ULN or elevated alanine aminotransferase or aspartate aminotransferase >3×ULN at Baseline)
- •4. Has severe renal insufficiency (glomerular filtration rate =29 mL/min at Baseline)
- •5. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- •6. Has prolonged QT interval corrected for heart rate using Fridericia’s equation (QTcF) (>450 ms for men and >470 ms for women) with normal QRS interval (<120 ms) or QTcF interval >500 ms with wide QRS interval (=120 ms)
- •7. Has received pituitary radiation therapy for a Cushing syndrome-related tumor within 1 year of Screening
- •8. Has used or plans to use any of the following treatments for Cushing syndrome within
- •4 weeks prior to Baseline:
- •Mifepristone
- •Adrenostatic medications: metyrapone, ketoconazole, fluconazole, aminoglutethimide, or etomidate
- •Serotonin antagonists: cyproheptadine, ketanserin, or ritanserin
- •Dopamine agonists: bromocriptine or cabergoline
- •Gamma-aminobutyric acid agonists: sodium valproate
- •Short-acting somatostatin analogs: octreotide, lanreotide, or pasireotide
- •9. Has used or plans to use somatostatin receptor ligands: long-acting octreotide or pasireotide within 8 weeks prior to Baseline
- •10. Has adrenocortical carcinoma
- •11. Has ectopic Cushing syndrome and a life expectancy of <3 years
- •12. Has pseudo-Cushing syndrome. Patients with known or suspected pseudo-Cushingsyndrome based on medical history (such as patients with severe obesity, major depression, or a history of alcoholism) should undergo a dexamethasone-CRHDDAVP stimulation test to rule-in or rule-out this possibility
- •13. Has taken any investigational drug within 4 weeks prior to Baseline, or within less than 5 times the drug’s half-life, whichever is longer
- •14. Ongoing use of antidiabetic, antihypertensive, antidepressant, or lipid-lowering medications that are highly dependent on CYP3A for clearance and require dose modification upon coadministration with strong CYP3A inhibitors
- •15. Ongoing use of any strong CYP3A4 inhibitor or any other prohibited medications
- •16. Is pregnant or lactating
- •17. Has an acute or unstable medical problem that could be aggravated by treatment with the investigational study drug
- •18. Has a history of hypersensitivity or severe reaction to the study drug, to a similar class of drug, or to the study drug’s excipient
- •19. In the Investigator’s opinion, should not participate in the study or may not be capable of following the study schedule
- •20. Has known HIV or hepatitis B or C infection
- •21. Is a family member of one of the Sponsor’s employees, the Investigator, or the site staff directly working on the study
研究者
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