NL-OMON45794已完成3 期
Open-label extension study to evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study - TRAVERSE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
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
- •- Patients with asthma who completed the treatment period in a previous dupilumab asthma clinical study (ie, PDY14192, EFC13579 or EFC13691) or patients with asthma who completed the treatment and follow-up periods in pervious dupilumab asthma study DRI12544
- •- Patient is on a stable background dose of moderate or high dose inhaled ICS [(fluticasone propionate greater than 250 *g twice daily (or equipotent)] for ><= 1 month prior to V1 )
- •- Signed written informed consent
排除标准
- •** Exclusion criteria related to study methodology **
- •E 01. Patients who have not completed the treatment period in PDY14192, EFC13579, or EFC13691 studies or the treatment and follow up periods in DRI12544 study
- •E 02. Chronic obstructive pulmonary disease (COPD) or other lung diseases (e.g., emphysema,
- •idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impair pulmonary function tests
- •E 03. Current smoker (smoking history >10 pack-years) or previous smoker (within 6 months
- •prior to V1)
- •E 04. Clinically significant comorbidity/lung disease other than asthma
- •E 05. Alcohol abuse or drug abuse
- •E 06. Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders)
- •E 07. Reversal of sleep pattern (eg, night shift workers)
- •E 08. Patients requiring beta-adrenergic receptor blockers (beta blockers) for any reason
- •E 09. Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days prior to Visit 1; biologic therapy within 6 months prior to Visit 1 (not including parent dupilumab study)
- •E 10. Patient receiving concomitant treatment prohibited in the study (see Protocol section 8.8.1)
- •E 11. Exposure to another investigative antibody within a time period prior to Visit 1 that is less
- •than 5 half-lives of the antibody (if known). In case the half-life is not known, then the minimum interval since exposure to the prior investigative antibody is 6 months. The minimum interval since exposure to any other (non-antibody) investigative study medication is 30 days prior to Visit 1
- •E 12. Patient is Investigator or any Sub-Investigator, research assistant, pharmacist, study
- •coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •E 13. Concomitant severe disease;** Exclusion criteria related to the active comparator and/or mandatory background therapies **
- •E 14. Diseases for which the use of background therapies are contraindicated, e.g., ICS (active
- •and inactive pulmonary tuberculosis) or LABA
- •E 15. Treatment with drugs associated with clinically significant QTc interval prolongation/ Torsades de Pointes ventricular tachycardia;** Exclusion criteria related to the current knowledge of Sanofi compound **
- •E 16. Patients with any event or laboratory abnormality per investigator judgment, would adversely affect participation of the patient in this study
- •E 17. Pregnant or breastfeeding women
- •E 18. (A) Women of childbearing potential (pre-menopausal female biologically capable of becoming pregnant) who:
- •* Do not have a confirmed negative serum *-hCG test at Visit 1
- •* Who are not protected by acceptable forms of effective contraception during the study, including the 16-week follow-up period as stated in the Protocol
- •(B) Male participant with a female partner of childbearing potential not protected by
- •acceptable method(s) of birth control (as defined in the Protocol).
- •E 19. Diagnosed active parasitic infection; suspected or high risk of parasitic infection, unless
- •clinical and (if necessary) laboratory assessments have ruled out active infection before enrolment
- •E 20. History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV-1 and HIV-2 antibodies) at Visit 1
- •E 21. Known or suspected history of immunosuppression, including history of invasive opportunistic infections
研究者
相似试验
进行中（未招募）
1 期
ong-Term Safety Evaluation of dupilumab in patients with asthmaAsthmaMedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2013-003856-19-ITSanofi-aventis recherche et développement2,282
进行中（未招募）
1 期
ong-Term Safety Evaluation of dupilumab in patients with asthmaMedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2013-003856-19-ESSanofi-aventis recherche et développement560
进行中（未招募）
1 期
A study to assess the long-term safety and efficacy of dupilumab administered in patients 6 months to <18 year of age with atopic dermatitis (eczema)MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic dermatitisEUCTR2015-001396-40-PLRegeneron Pharmaceuticals, Inc.812
进行中（未招募）
1 期
A study to assess the long-term safety and efficacy of dupilumab administered in patients =6 months to <18 year of age with atopic dermatitis (eczema)MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersAtopic dermatitisEUCTR2015-001396-40-DERegeneron Pharmaceuticals, Inc.812
进行中（未招募）
1 期
A study to assess the long-term safety and efficacy of dupilumab administered in patients =6 months to <18 year of age with atopic dermatitis (eczema)Atopic dermatitisEUCTR2015-001396-40-GBRegeneron Pharmaceuticals, Inc.812