EUCTR2021-002609-93-NL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicenter, dose-ranging Phase 2 study of rilzabrutinib followed by an open-label extension phase in patients with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 213
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
- 性别
- All
入选标准
- •- Participants who have a diagnosis of CSU refractory to H1-AH at the time of randomization
- •- Diagnosis of CSU =3 months prior to screening visit (Visit 1).
- •- The presence of itch and hives for =6 consecutive weeks at any time prior to screening visit (Visit 1) despite the use of H1-AH during this time period.
- •- Participants using a study defined H1-AH for CSU treatment. For participants on stable doses of non-study-approved H1-AH, investigators may switch participants to an equivalent dose of a study-approved H1-AH maintenance medication.
- •- Participants who are omalizumab naïve OR omalizumab-incomplete responders.
- •- Participants must be willing and able to complete a daily symptom e-diary for the duration of the study.
- •- During the 7 days before randomization: UAS7 =16 and ISS7 =8
- •- Body mass index (BMI) >17.5 and <40 kg/m2.
- •- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 73
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Clearly defined underlying etiology for CUs other than CSU (main manifestation being physical urticaria)
- •- Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.
- •- Participants with active atopic dermatitis (AD).
- •- Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study.
- •- Known or suspected immunodeficiency, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.
- •- History of serious infections requiring intravenous (IV) therapy with the potential for recurrence (as judged by the Site Investigator and the Sponsor Medical Monitor) with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher), including active coronavirus disease 2019 (COVID-19)
- •- Live vaccine except Bacille Calmette Guerin-vaccination within 28 days prior to Day 1 or plan to receive one during the trial; Bacille Calmette Guerin-vaccination within 12 months prior to Screening.
- •- Active malignancy or history of malignancy within 5 years
- •- Conditions that may predispose the participant to excessive bleeding
- •- Any participant with an uncontrolled disease state as judged by the Investigator, such as asthma, psoriasis, or inflammatory bowel disease, etc. that are typically treated with oral or parenteral corticosteroids
- •- Previous use of a BTK inhibitor.
- •- Has received any investigational drug (or is currently using an investigational device) within the 30 days before Day 1, or at least 5 times the respective elimination half-life time (whichever is longer).
- •- Previous exposure to another investigative drug for CSU
- •- Positive for human immunodeficiency virus (HIV) antibody test.
- •- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with positive DNA test result at screening or within 3 months prior to the screening visit.
- •- Positive hepatitis C antibody test result at screening or within 3 months prior to the screening visit.
- •- Tuberculosis infection
- •- Any of significant laboratory abnormalities and ECG findings at the screening visit
研究者
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