EUCTR2019-004765-40-LT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- 性别
- All
入选标准
- •1.Male and female subjects = 18 years old at screening
- •2.Has a known childhood diagnosis of classic CAH due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or documented (at any time) elevated 17-OHP and currently treated with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combinaton of the aforementionned GCs)
- •3.Has LLD = A4 = 2.5x ULN at screening measured before an am GC dose
- •4. Has been on a stable, supraphysiologic dose of GC replacement (defined as =30 mg/day and =60 mg/day in HCe) for =1 month before screening
- •5.For subjects with the salt-wasting form of CAH, subject has been on a stable dose of mineralocorticoid replacement for =1 month before screening
- •6. Follow contraception guidelines . Male subjects must also agree to refrain from donating sperm throughout the Treatment Period and for 90 days after the last dose of study drug.
- •7.Is able to understand all study procedures and risks involved and provides written informed consent indicating willingness to comply with all aspects of the protocol.
- •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 85
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Has a known or suspected diagnosis of any other known form of classic CAH (not due to 21 hydroxylase deficiency)
- •2.Has a history that includes bilateral adrenalectomy or hypopituitarism
- •3.Has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other CRF1 receptor antagonist
- •4.Shows clinical signs or symptoms of adrenal insufficiency
- •5.Has had a clinically significant unstable medical condition, medically significant illness, or chronic disease occurring within 30 days of screening, including but not limited to:
- •a.An ongoing malignancy or <3 years of remission history from any malignancy, other than successfully treated localized skin cancer
- •b.Estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73 m2
- •c. Current or history of liver disease
- •d. History of alcohol or substance abuse within the last year
- •e. Active hepatitis B, C or HIV at screening
- •f. subjects who plan to undergo bariatric surgery during the study are excluded
- •g. any other condition that would impact subject safety or confound interpretation
- •6.Psychiatric conditions, including but not limited to bipolar disorder, schizophrenia, or schizoaffective disorders that are not effectively controlled on medication and may have an adverse impact on study compliance. Symptoms including hallucinations, delusions, and psychosis are exclusionary. Additionally:
- •a. Increased risk of suicide based on the Investigator’s judgment or the results of the Columbia–Suicide Severity Rating Scale (C SSRS) conducted at screening and baseline (eg, C-SSRS Type 3, 4, or 5 ideation within the past 6 months or any suicidal behavior within the past 12 months)
- •b. HADS score >12 for either depression or anxiety at screening or baseline
- •7.Has clinically significant abnormal ECG or clinical laboratory results.
- •8. Routinely works overnight shifts
- •9.Subjects with travel plans/work schedules that result in significant and frequent changes in time zones (>2 hours) will require Medical Monitor approval for enrollment.
- •10.Females who are pregnant or nursing
- •11.Use of any other investigational drug from 30 days or 5 half-lives (whichever is longer) before screening to the end of the study
- •12.Use of the following drugs from 30 days or 5 half-lives (whichever is longer) before the start of the Treatment Period to the end of the study
- •a. Rosiglitazone, aromatase inhibitors, testosterone, or growth hormones, or any other medication or supplement that could impact subject safety or confound interpretation of study results
- •b. The drugs listed in Section 13.1
- •13.Donation or receipt of blood from 90 days before Screening to the end of the study; donation or receipt of platelets, white blood cells, or plasma from 30 days before Screening to the end of the study
研究者
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