CTRI/2022/02/040702招募中3 期
A multicenter, randomized, double-blind, placebo-controlled Phase 3 study ofremibrutinib (LOU064) to investigate the efficacy, safety and tolerability for52 weeks in adult chronic spontaneous urticaria patients inadequatelycontrolled by H1-antihistamines
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •Signed informed consent must be obtained prior to participation in the
- •Ã¯â??· Male and female adult participants ââ?°Â¥18 years of age at the time of
- •Ã¯â??· CSU duration for ââ?°Â¥ 6 months prior to screening (defined as the onset of
- •CSU determined by the investigator based on all available supporting
- •documentation).
- •Ã¯â??· Diagnosis of CSU inadequately controlled by second generation H1-
- •antihistamines at the time of randomization defined as:
- •Ã¯â??· The presence of itch and hives for ââ?°Â¥6 consecutive weeks prior to
- •screening despite the use of second generation H1-antihistamines
- •during this time period
- •Ã¯â??· UAS7 score (range 0-42) ââ?°Â¥16, ISS7 score (range 0-21) ââ?°Â¥ 6 and
- •HSS7 score (range 0-21) ââ?°Â¥ 6 during the 7 days prior to
- •randomization (Day 1)
- •Ã¯â??· Documentation of hives within three months before randomization (either
- •at screening and/or at randomization; or documented in the participants
- •medical history).
- •Ã¯â??· Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for
- •the duration of the study and adhere to the study protocol.
- •Ã¯â??· Participants must not have had more than one missing UPDD entry
- •(either morning or evening) in the 7 days prior to randomization (Day 1).
排除标准
- •1.Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia
- •(symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed
- •pressure-, aquagenic-, cholinergic-, or contact-urticaria
- •Ã¯â??· 2.Other diseases with symptoms of urticaria or angioedema, including but
- •not limited to urticaria vasculitis, urticaria pigmentosa, erythema
- •multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
- •Ã¯â??· 3.Any other skin disease associated with chronic itching that might
- •influence in the investigatorââ?¬•s opinion the study evaluations and results,e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis,senile pruritus or psoriasis
- •4.Evidence of clinically significant cardiovascular (such as but not limited
- •to myocardial infarction, unstable ischemic heart disease, New York heart association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1),neurological, psychiatric, pulmonary, renal, hepatic, endocrine,metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigators opinion, would compromise the safety of the participant,interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the
- •participant
- •Ã¯â??· 5.Significant bleeding risk or coagulation disorders
- •Ã¯â??·6. History of gastrointestinal bleeding, e.g. in association with use of
- •nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant
- •(e.g. requiring hospitalization or blood transfusion)
- •Ã¯â??·7. Requirement for anti-platelet medication, except for acetylsalicylic acid
- •up to 100 mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g.
- •acetylsalicylic acid + clopidogrel) is prohibited.
- •Ã¯â??·8. Requirement for anticoagulant medication (for example, warfarin or
- •Novel Oral Anti-Coagulants (NOAC))
- •Ã¯â??·9. History or current hepatic disease including but not limited to acute or
- •chronic hepatitis, cirrhosis or hepatic failure or Aspartate
- •Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more
- •than 1.5 x upper limit of normal (ULN) or International Normalized Ratio
- •(INR) of more than 1.5 at screening
研究者
相似试验
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab 2 mL pre-filled syringe (300 mg) in subjects with moderate to severe plaque psoriasisPlaque psoriasisEUCTR2015-005170-38-BEovartis Pharma Services AG210
进行中（未招募）
1 期
Efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failureEUCTR2013-001498-25-IEovartis Pharma Services AG6,800
进行中（未招募）
1 期
A clinical study to evaluate iloperidone in the treatment of patients with acute manic episodes associated with Bipolar I DisorderEUCTR2020-000405-83-PLVanda Pharmaceuticals Inc.400
已完成
不适用
HVTN 705/VAC89220HPX2008PACTR201705002290492Janssen Vaccines & Prevention B.V.2,600
进行中（未招募）
1 期
A study to investigate the safety and effectiveness of different doses of a new drug (sprifermin- also called AS902330) in patients with osteoarthritis of the kneePrimary osteoarthritisMedDRA version: 16.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859EUCTR2011-003059-20-PLMerck KGaA545