EUCTR2019-004764-22-SE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •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 combination of the aforementioned GCs)
- •3.For subjects with the salt-wasting form of CAH, the subject is on a stable dose of mineralocorticoid replacement for =1 month before screening
- •4.Agrees to 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.
- •5. 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 67
- •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, or any of its excipients or any other CRF1 receptor antagonist
- •4.Current treatment with dexamethasone as GC therapy for CAH
- •5.Is not adherent to GC or study drug dosing regimen during the Run-in Period (defined as taking <80% of expected doses based on drug accountability)
- •6.Shows clinical signs or symptoms of adrenal insufficiency
- •7.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.Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening
- •8.Had or has a clinically significant psychiatric disorder, including the following:
- •a.Psychiatric conditions, including but not limited to depression, bipolar disorder, schizophrenia or schizoaffective disorder that are not effectively controlled on medication and may have an adverse impact on study compliance. Symptoms including hallucinations, delusions and psychosis are exlcusionary.
- •b.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 Week 6 (eg, C-SSRS Type 3, 4, or 5 ideation within the past 6 months or any suicidal behavior within the past 12 months)
- •c.HADS score >12 for either depression or anxiety at screening or Week 6
- •9. Has clinically significant abnormal ECG or clinical laboratory results.
- •10. Routinely works overnight shifts
- •11. 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
- •12.Females who are pregnant or nursing
- •13.Use of any other investigational drug from 30 days or 5 half-lives (whichever is longer) before screening to the end of the study
- •14.Use of the following drugs from 30 days or 5 half-lives (whichever is longer) before Day 1 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.drugs listed in section 13.1
- •15.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
相似试验
进行中（未招募）
1 期
Study to test the efficacy and safety of Padsevonil as adjunctive treatment of focal-onset seizures in adults with drug-resistant epilepsyFocal-Onset SeizuresMedDRA version: 20.0Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852EUCTR2017-003200-48-LTCB Biopharma SPR411
进行中（未招募）
不适用
A study to evaluate the efficacy of different doses of LY3009104 therapy compared to placebo in patients with Rheumatoid Arthritis who are on ongoing methotrexate background therapy.MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2010-022504-42-HUEli Lilly and Company270
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart FailureHeart FailureEUCTR2013-002893-35-SKTrevena Inc.500
进行中（未招募）
1 期
This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 70 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baselineClassic Congenital Adrenal HyperplasiaMedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850EUCTR2019-004764-22-PLSpruce Biosciences, Inc.72
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back PaiModerate to severe, chronic, low back pain (LBP) that is not adequately controlled by standard pain therapyMedDRA version: 9.1Level: LLTClassification code 10024891Term: Low back painEUCTR2009-009857-17-BEJanssen-Cilag International NV360