EUCTR2013-003254-24-RO进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 740
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 or female, 18 years or older
- •2. Chronic AD, (according to the American Academy of Dermatology
- •Consensus Criteria),that has been present for at least 3 years before the
- •screening visit.
- •3. Patients with documented recent history (within 6 months before the
- •screening visit) of inadequate response to a sufficient course of
- •outpatient treatment with topical AD medication(s), or for whom topical AD therapies are medically inadvisable.
- •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 382
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •1. Prior treatment with dupilumab
- •2. Recent treatment (within specific time windows before the baseline
- •visit) with systemic corticosteroids, immunosuppressive agents, topical
- •corticosteroids and calcineurin inhibitors, live (attenuated) vaccine,
- •other investigational drugs
- •3. History of human immunodeficiency virus (HIV) infection
- •4. HIV or viral hepatitis seropositivity at screening
- •5. Known or suspected immunosuppresion
- •6. Recent infections requiring antiinfectious treatment
- •7. Recent history or high risk of clinical endoparasitoses
- •8. High risk populations (low life expectancy, severe concomitant
- •diseases, etc.)
- •9. Pregnant or breast-feeding women
- •10. Patients of reproductive potential and sexually active who are
- •unwilling to use adequate
研究者
相似试验
进行中（未招募）
1 期
This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)Subjects with moderately to severely active Crohn's diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2021-002869-18-BEAbbVie Deutschland GmbH & Co. KG265
进行中（未招募）
1 期
Clinical Trial to compare if seriously-ill adults with constipation due to narcotics have bowel movements sooner after injection with Methylnatrexone or placeboEUCTR2007-000854-30-BESalix Pharmaceuticals Inc254
进行中（未招募）
不适用
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 17.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861EUCTR2013-002343-29-GBRegeneron Pharmaceuticals, Inc.803
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease - E5555-G000-201Coronary Artery DiseaseMedDRA version: 8.1Level: PTClassification code 10011078EUCTR2005-006029-94-BEEisai Limited720
已完成
不适用
A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109abdominal pain and heartburn10017943NL-OMON30044Janssen-Cilag82