NL-OMON54706已完成3 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 - CORT125134-455 (ICON 0115/0015)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 night 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) (American Diabetes Association 2020) • 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
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 mm Hg 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
- •syndrome-related 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-CRH
- •DDAVP stimulation test (Yanovski et al.1993, Giraldi et al. 2007, Yanovski et
- •al. 1998) to rule-in or rule-out 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 (Section
- •5.4.4) 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 m
研究者
相似试验
进行中（未招募）
1 期
A study to assess whether a product call relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Endogenous Cushing syndromeMedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860EUCTR2018-003096-35-ESCorcept Therapeutics Incorporated130
进行中（未招募）
1 期
A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Endogenous Cushing syndromeMedDRA version: 24.0Level: LLTClassification code 10011657Term: Cushings syndromeSystem Organ Class: 10014698 - Endocrine disordersEUCTR2018-003096-35-NLCorcept Therapeutics Incorporated162
进行中（未招募）
1 期
A study to assess whether relacorilant works and is safe to use in patients with Hypercortisolism due to Cortisol-Secreting Adrenal Adenomas or Hyperplasia; some patients will receive relacorilant whilst others receive a placebo.hypercortisolismMedDRA version: 22.1Level: LLTClassification code 10020611Term: HypercortisolismSystem Organ Class: 100000004860EUCTR2019-004956-12-ITCORCEPT THERAPEUTICS130
进行中（未招募）
1 期
A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Endogenous Cushing syndromeMedDRA version: 24.0Level: LLTClassification code 10011657Term: Cushings syndromeSystem Organ Class: 10014698 - Endocrine disordersEUCTR2018-003096-35-PLCorcept Therapeutics Incorporated162
进行中（未招募）
1 期
A study to assess whether relacorilant works and is safe to use in patients with Hypercortisolism due to Cortisol-Secreting Adrenal Adenomas or Hyperplasia; some patients will receive relacorilant whilst others receive a placebo.EUCTR2019-004956-12-DECorcept Therapeutics Incorporated130