EUCTR2019-001703-20-DE进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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. Males and females, 12 years of age and older for subjects with non-histaminergic normal C1-INH angioedema at the time of signing of the informed consent form (ICF).
- •2. Documented clinical history of recurrent attacks of angioedema in the absence of wheals/urticaria.
- •3. Investigator-confirmed diagnosis of non-histaminergic bradykinin-mediated angioedema with with normal C1-INH as documented by a history
- •of angioedema attacks at screening and occurrence of attack(s) during the observation period.
- •4. - History of recurrent angioedema with at least an average of 1
- •angioedema attack per 4 weeks prior to screening and this attack rate
- •must be confirmed during the observation period while treated with
- •chronic high-dose antihistamine (cetirizine 40 mg/day or equivalent
- •high-dose second-generation antihistamine medication).
- •- Diagnostic testing results obtained during screening from a sponsorapproved
- •central laboratory that confirm C1-INH function =50% of
- •normal and normal C4. With prior sponsor approval, subjects may be
- •retested during the observation period if results are incongruent with
- •clinical history.
- •- Clinical history of not responding to high-dose antihistamine treatment
- •(cetirizine 40 mg/day or equivalent high-dose second-generation
- •antihistamine medication), which must be confirmed during the
- •observation period with at least 1 angioedema attack per 4 weeks with
- •chronic high-dose antihistamine treatment and no significant difference
- •(as assessed by the investigator and in consultation with the sponsor's
- •medical monitor, as necessary) from the historic attack rate without
- •high-dose antihistamine treatment.
- •5. Agree to adhere to the protocol-defined schedule of treatments,
- •assessments, and procedures. Subjects =18 years of age must be willing
- •to use icatibant as the rescue medication during the
- •observation and treatment period. During the observation period,
- •subjects need to be treated with icatibant for at least 2 angioedema
- •attacks or at least 1 moderate or severe attack. In the opinion of the
- •investigator, subjects with no response to icatibant for acute
- •angioedema attacks in the past medical history/screening, or no
- •improvement or worsened attack severity 2 hours after icatibant
- •treatment during the observation period (based on totality of
- •assessments), will not be included. Note: For subjects 12 to <18 years of
- •age, standard of care therapy per local protocols should be provided.
- •6. Males, or non-pregnant, non-lactating females who are of childbearing
- •potential and who agree to be abstinent or agree to comply with
- •the applicable contraceptive requirements of this protocol for the
- •duration of the study. Female subjects of childbearing potential must
- •have a negative serum pregnancy test at screening and must be willing
- •to undergo pregnancy tests throughout the study. Females of nonchildbearing
- •potential are defined as surgically sterile (status post
- •hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or
- •post-menopausal for at least 12 months.
- •7. The subject (or the subject's parent/legal guardian, if applicable) has
- •provided written informed consent approved by the institutional review
- •board/research ethics board/ethics committee (IRB/REB/EC).
- •If the subject is an adult, be informed of the nature of the study and
- •provide written informed consent before any study-specific procedures
- •are performed.
- •If the subject is a minor (ie, <18 years of age), have a parent/legal
- 另有 1 项未显示
排除标准
- •1. Concomitant diagnosis of Type I or Type II HAE, or recurrent
- •angioedema associated with urticaria.
- •2. Dosing with any investigational drug or exposure to an investigational
- •device within 4 weeks prior to screening.
- •3. Exposure to angiotensin-converting enzyme (ACE) inhibitors or
- •rituximab within 6 months prior to screening.
- •4. Use of any estrogen-containing medications with systemic absorption
- •(such as oral contraceptives or hormonal replacement therapy) within 4
- •weeks prior to screening.
- •5. Response to omalizumab (prophylactic) or corticosteroid
- •(acute/prophylactic) or epinephrine (acute) or anti-leukotrienes
- •(prophylactic) treatments in the past.
- •6. Use of long-term prophylactic therapy for HAE, eg, C1-INH, attenuated
- •androgens (eg, danazol, methyltestosterone, testosterone), or antifibrinolytics
- •within 2 weeks prior to entering the observation period as
- •long as the investigator determines that doing so would not place the
- •subject at any undue safety risk, and that the subject is at least 18 years
- •7. Any exposure to prophylactic plasma kallikrein inhibitors prior to
- •8. Use of short-term prophylaxis for HAE within 7 days prior to entering
- •the observation period. Short-term prophylaxis is defined as C1-INH,
- •attenuated androgens, or antifibrinolytics used to avoid angioedema
- •complications from medically indicated procedures.
- •9. Have any active infectious illness or fever defined as an oral
- •temperature >38°C (100.4°F), tympanic >38.5°C (101.3°F), axillary
- •>38°C (100.4°F), or rectal/core >38.5°C (101.3°F) within 24 hours prior
- •to the first dose of study drug in the treatment period.
- •10. Any of the following liver function test abnormalities: ALT >3x upper
- •limit of normal, or AST >3x upper limit of normal, or total bilirubin >2x
- •upper limit of normal (unless the bilirubin elevation is a result of
- •Gilbert's syndrome).
- •11. Pregnancy or breast feeding.
- •12. Subject has a known hypersensitivity to the investigational product
- •or its components.
- •13. Have any uncontrolled underlying medical condition which would
- •require treatment adjustment during the study treatment period, that, in
- •the opinion of the investigator or sponsor, may confound the results of
- •the safety assessments or may place the subject at risk. Subjects with
- •stable treatment for at least 3 months prior to screening and NOT
- •expecting any change to their treatment regimen for 6 months during
- •the study treatment period, will not be excluded.
- •14. Have any condition (surgical or medical) that, in the opinion of the
- •investigator or sponsor, may compromise their safety or compliance,
- •preclude the successful conduct of the study, or interfere with
- •interpretation of the results (eg, significant pre-existing illness or other
- •major comorbidities that the investigator considers may confound the
- •interpretation of study results).
研究者
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