EUCTR2020-003018-11-FR进行中（未招募）1 期
A multi-center, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 428
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. Signed informed consent must be obtained before any assessment is performed.
- •2. Participant’s parent’s or legal guardian’s signed informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed.
- •3. Male and female participants = 12 years of age at the time of screening.
- •4. Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for = 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)).
- •5. Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization
- •6. Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
- •7. Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
- •8. Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 22
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 325
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •1. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days for small molecules prior to the screening visit or until the expected pharmacodynamic effect has returned to baseline for biologics, whichever is longer.
- •2. History of hypersensitivity to any of the study drugs or its components or to drugs of similar classes (i.e. to murine, chimeric or human antibodies) or to the provocation test or items used in provocation tests
- •3. Participants who have any concomitant CSU at screening
- •4. Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study
- •5. Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
- •6. Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
- •7. Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
- •8. Prior exposure to ligelizumab, omalizumab or other anti-IgE therapies
- •9. Female participants, including adolescent females of 12 to less than 18 years of age, of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
研究者
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