LBCTR2022014919暂停3 期
A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
ovartis Pharmaceuticals0 个研究点目标入组 8 人开始时间: 2023年2月27日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 至 99（—）
- 性别
- All
入选标准
- •Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for = 4 months.
- •Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:
- •Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH
- •Positive response (i.e. development of symptoms) to provocation test on day of randomization
- •Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
- •Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
- •Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules
排除标准
- •History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests
- •Participants who have concomitant CSU at screening
- •Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study
- •Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
- •Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
- •Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
- •Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies
研究者
相似试验
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing - M10-261, FINAL 30Nov07MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid ArthritisEUCTR2007-005905-23-GBAbbott GmbH & Co. KG424
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week DosingRheumatoid ArthritisEUCTR2007-005905-23-DEAbbott GmbH & Co. KG424
已完成
2 期
A Dose response study in patients with mild to moderate hypertension.CTRI/2011/04/001682ovartis Healthcare Pvt Ltd910
进行中（未招募）
1 期
To assess the efficacy of NTRA-2112 on intestinal malabsorption due to gastro-intestinal immaturity by measuring the time required to reach full enteral feeding in preterm infants during the treatment period compared to a placebo formulation.Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.MedDRA version: 20.1Level: LLTClassification code 10025479Term: Malabsorption syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1Level: PTClassification code 10025476Term: MalabsorptionSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2014-002624-28-FRutrinia300
进行中（未招募）
1 期
Efficacy and Safety of Deucravacitinib in Adults with Alopecia AreataMedDRA version: 20.0Level: PTClassification code 10001761Term: Alopecia areataSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersAlopecia AreataEUCTR2020-000113-33-FRBristol-Myers Squibb International Corporation90