EUCTR2017-002581-51-DE进行中（未招募）1 期
An Open-Label, Pilot Study to Assess the Efficacy and Safety Of AK002 (Siglec-8) in Patients with Antihistamine-Resistant Chronic Urticaria - CURSIG
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Allakos Inc.
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Adults (= 18 and = 85 years old)
- •2) Body weight <125 Kg
- •3) Informed consent signed and dated
- •4) Able to read, understand, and willing to sign the informed consent form and comply with study procedures
- •5) Diagnosis of CU for at least 3 months, refractory to antihistamine treatment in single or 4-fold dosage
- •6) Willing, committed, and able to return for all clinic visits and complete all study-related procedures, including willingness to have IV infusion of study drug administered by a qualified person
- •7) Females of childbearing potential must have a negative pregnancy test at Baseline. Female subjects must be willing to use highly effective contraception (Pearl- 4 Index <1) or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years (FSH >40 mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
- •Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- •8) No participation in other clinical trials 4 weeks before participation in this study
- •9) Uncontrolled CU (UCT <12) at the time of enrollment
- •10) For extended dosing, subjects must have a baseline (Day 1) UCT of =5 and a week 22 (Day 155) UCT of = 12 (Complete Response). They must have a UCT of =5 post-week 22 (Day 155) and by week 44 (Day 309) i.e., within 6 months from last dose
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1) Acute urticaria
- •2) Concurrent/ongoing treatment with immunosuppressives (e.g.,
- •cyclosporine, methotrexate, dapsone, or others) within 4 weeks or
- •5 half-lives prior to Baseline, whichever is longer
- •3) Significant medical condition rendering the patient
- •immunocompromised or not suitable for a clinical trial
- •4) Significant concomitant illness that would adversely affect the
- •subject’s participation or evaluation in this study
- •5) History of malignancies within five years prior to screening other
- •than a successfully treated non-metastatic cutaneous, basal, or
- •squamous cell carcinoma and/or in situ cancer
- •6) Presence of clinically significant laboratory abnormalities
- •7) Lactating women or pregnant women
- •8) Substance abuse (drug or alcohol) or any other factor (e.g., serious
- •psychiatric condition) within the last 5 years that could limit the
- •subject’s ability to comply with study procedures
- •9) Subjects who are detained officially or legally to an official
- •institute or those that have been committed to an institution by
- •virtue of an order issued either by the judicial or the administrative
- •authorities will be excluded from the study
- •10) Use of omalizumab within the last 2 months
- •11) Receipt of intravenous IgG therapy 30 days prior to Baseline
- •12) Plasmapheresis 30 days prior to Baseline
- •13) Use (daily or every other day) of Doxepin 14 days prior to Baseline
- •14) Receipt of inactive vaccination or live attenuated vaccine 30 days
- •prior to Baseline
- •15) Use of H2 antihistamines 7 days before Baseline
- •16) Intake of leukotriene antagonists within 7 days prior to enrollment
- •17) Intake of systemic corticosteroids (e.g., oral or depot) within 14
- •days prior to enrollment
- •18) Positive screening for ova and parasite test at Baseline
- •19) Treatment of helminthic parasite within 6 months of screening
- •20) Positive HIV serology at screening
- •21) Positive Hepatitis serology at baseline, except for vaccinated
- •patients or patients with past but resolved hepatitis at screening
- •22) Donation or loss of >500ml of blood within 56 days prior to
- •administration of study drug or donation of plasma within 7 days
- •prior to administration of drug
- •23) Known hypersensitivity to any ingredients of AK002 or drugs
- •related to AK002 (e.g., monoclonal antibodies, polyclonal gamma
研究者
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