EUCTR2019-001235-31-DE进行中（未招募）1 期
Factor XII-associated cold autoinflammatory syndrome (FACAS) linked tokallikrein-kinin pathology: Proof of concept treatment with Lanadelumab(DX-2930) - LANA-FXII
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4
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
- •Adolescents (12 - 17 years old) and adults (18 years or older)
- •Documented FXII-associated autoinflammatory disorder (FACAS) by positive genetic analysis result
- •Clinical symptoms of cold-associated wheals, arthralgia, headache, fatigue
- •Able to read, understand and willing to sign the informed consent form and abide with study procedures
- •Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study as follows:
- •Females of childbearing potential must agree to be abstinent or else use one of the following medically acceptable forms of contraception from the screening period through 30 days after the final study visit: progestin-only oral contraceptive, intrauterine device, progestin depot injection or progestin implant. A female whose male partner has had a vasectomy must agree to use one additional form of highly effective contraception (Pearl-Index <1).
- •Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months do not require contraception during the study.
- •Males, including males who are surgically sterile (post vasectomy), with female partner(s) of childbearing potential must agree to be abstinent or else the female partner(s) have to use a highly effective form of contraception (Pearl-Index <1) from the screening period through 60 days after the final study visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Any other forms of urticaria or angioedema not related to genetic mutations within the FXII gene
- •Concurrent/ongoing treatment with biologics or recent treatment (less than 5 half-lives)
- •With anakinra within 7 days prior to screening, with canakinumab within 100 days prior to screening
- •with oral/parental corticosteriods greater than 10 mg/d within 2 weeks prior to screening
- •o other immunosuppressives within 4 weeks or 5 half-lives prior to screening, whichever is longer
- •Treatment with a live (attenuated) virus vaccine within 4 weeks prior to Baseline visit
- •Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral
- •contraceptives or hormonal replacement therapy) within 4 weeks prior to screening
- •Use of prophylactic therapy with C1-INH, attenuated androgens, or antifibrinolytics within 2 weeks prior to the start of the treatment period
- •Any of the following liver function test abnormalities:
- •o alanine aminotransferase (ALT) > 3x upper limit of normal, or
- •o aspartate aminotransferase (AST) > 3x upper limit of normal, or
- •o total bilirubin > 2x upper limit of normal (unless the bilirubin
- •elevation is a result of Gilbert's Syndrome).
- •Pregnancy or breastfeeding.
- •Subject has any condition that, in the opinion of the Investigator or Sponsor, may compromise their safety or compliance, preclude
- •successful conduct of the study, or interfere with interpretation of the results (e.g., history of substance abuse or dependence, a significant
- •pre-existing illness or other major comorbidity that the Investigator considers may confound the interpretation of study results).
- •Significant medical condition rendering the patient immuno-compromised or not suitable for a clinical trial
- •Enrollment in another investigational treatment or device study or use of an investigational agent, or less than 4 weeks or 5 half-lives,
- •whichever is longer, since end of another investigational device or drug trial
- •Patients with known hypersensitivity to any constituent of the products of lanadelumab
- •Dementia, altered mental status, or any psychiatric condition, or stay in an institution further to an official or court order that would prohibit
- •the understanding or rendering of informed consent or participation in the study.
- •Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
研究者
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