JPRN-jRCT2061210066进行中（未招募）3 期
A Multicenter, Open-label Phase 3 Study of Remibrutinib (LOU064) to Investigate the Safety, Tolerability and Efficacy for 52 Weeks in Adult Japanese Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-antihistamines - BISCUIT
Hiroyuki Yamada0 个研究点目标入组 70 人开始时间: 2021年12月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Signed informed consent must be obtained prior to participation in the study.
- •2) Male and female participants >=18 years of age.
- •3) CSU duration for >= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
- •4) Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at baseline defined as:
- •- The presence of itch and hives for >= 6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period
- •- UAS7 score (range 0-42) >= 16, ISS7 score (range 0-21) >= 6 and HSS7 score (range 0-21) >= 6 during the 7 days prior to baseline (Day 1)
- •5) Documentation of hives within three months before baseline (either at screening and/or at baseline; or documented in the participants' medical history).
- •6) Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol
- •7) Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to baseline (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
- •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
- •3) Any other skin disease associated with chronic itching that might influence in the investigator'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 investigator's 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
- •5) Significant bleeding risk or coagulation disorders
- •6) History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti- nflammatory drugs (NSAID), that was clinically relevant (e.g., requiring hospitalization or blood transfusion)
- •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.
- •8) Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC))
- •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
Comparative study of ribociclib and palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA trialEUCTR2021-002027-38-PTSOLTI306
进行中（未招募）
1 期
Comparative study of ribociclib and palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA trialPatients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancerEUCTR2021-002027-38-ESSOLTI516
进行中（未招募）
1 期
Clinical trial of Pembrolizumab/Vibostolimab Coformulation (MK-7684A)plus chemotherapy compared to pembrolizumab plus chemotherapy formetastatic non-small cell lung cancerFirst-line treatment of metastatic NSCLCMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-004564-94-DEMerck Sharp & Dohme LLC700
进行中（未招募）
1 期
?Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)?Metastatic Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864CTIS2023-506074-12-00Merck Sharp & Dohme LLC739
进行中（未招募）
3 期
A Phase 3 study of MK-7684A in combination with chemotherapy in metastatic NSCLCJPRN-jRCT2031220098ohata Nijiro46