EUCTR2018-003096-35-PL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
- 162
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
- 性别
- All
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 > upper limit of normal (ULN) in at least 2 complete 24-hour tests within the screening window.
- •Late-night salivary cortisol >ULN in at least 2 tests (using a salivette) within the screening window (Note: Test is not appropriate for nigth shift workers and cannot be used to evaluate eligibility)
- •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 HbA1c =6.5%), 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, there has been no increase in medication dosage for at least 4 weeks prior to Baseline assessment
- •6. If receiving medical treatment for depression, there has been no increase in medication dosage for at least 6 weeks prior to Baseline
- •7. For women of childbearing potential, 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 146
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
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 a known long term history of both hypertension and diabetes (defined as both hypertension and diabetes diagnosed >10 years prior to the initial diagnosis of endogenous CS)
- •4. Has a history of cyclic Cushing's syndrome with fluctuating clinical manifestations
- •5. Has DM Type 1
- •6. Has abnormal liver test results (total bilirubin >1.5×ULN or elevated alanine aminotransferase or aspartate aminotransferase >3×ULN at Baseline)
- •7. Has severe renal insufficiency (glomerular filtration rate =29 mL/min at Baseline)
- •8. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- •9. 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)
- •10. Has received stereotactic radiation therapy for a Cushing syndromerelated tumor within 24 months of Baseline or conventional pituitary radiation therapy within 36 months of Baseline
- •11. Has undergone pituitary surgery <3 months prior to Screening
- •12. Has used or plans to use any of the following treatments for Cushing syndrome within 4 weeks prior to Baseline:
- •Mifepristone
- •Adrenostatic medications: metyrapone, osilodrostat, 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
- •13. Has used or plans to use somatostatin receptor ligands: long-acting octreotide or pasireotide within 8 weeks prior to Baseline
- •14. Patients who require inhaled glucocorticoid use and have no alternative option if their condition deteriorates during the study
- •15. Has adrenocortical carcinoma.
- •16. Has used mitotane prior to Baseline
- •17. Has ectopic Cushing syndrome and a life expectancy of <3 years or receiving chemotherapy.
- •18. Has pseudo-Cushing syndrome. Patients with known or suspected pseudo-Cushing syndrome 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 ruleout this possibility
- •19. 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
- •20. Ongoing use of antidiabetic, antihypertensive, antidepressant, or lipid-lowering medications that are highly dependent on CYP3A for clearance and that cannot undergo dose modification upon coadministration with strong CYP3A inhibitors.
- •21. Ongoing use of any strong CYP3A4 inducer or any other prohibited medications.
- •22. Is pregnant or lactating.
- •23. Is a female patient of childbearing potential (including all women <50 years old, women whose surgical sterilization was performed <6 months ago, and women who have had a menstrual period in the last 2 years) who cannot use a highly effective method of contraception.
- •24. Has an acute or unstable medical problem that could be aggravated by treatment with the investigational study drug.
- •25. Has a history of hypersensitivity or severe reaction to
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