EUCTR2019-002932-10-ES进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS - ADvocate1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 424
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
- •- Male or female adults and adolescents (=12 years and =40 kg).
- •- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit.
- •- Eczema Area and Severity Index (EASI) score =16 at the baseline visit.
- •- Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit.
- •- =10% body surface area (BSA) of AD involvement at the baseline visit.
- •- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- •- For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use an acceptable contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.
- •- Provide signed informed consent/assent.
- •Please see Protocol Section 4.1 for the full list of inclusion criteria.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 330
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Participation in a prior lebrikizumab clinical study.
- •- History of anaphylaxis as defined by the Sampson criteria.
- •- Treatment with topical corticosteroids, calcineurin inhibitors or Eucrisa within 1 week prior to the baseline visit.
- •- Prior treatment with dupilumab or tralokinumab.
- •- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- •a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- •b. Phototherapy and photochemotherapy (PUVA) for AD.
- •- Treatment with the following prior to the baseline visit:
- •a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- •b. Cell-depleting biologics, including to rituximab, within 6 months.
- •c. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- •- Use of prescription moisturizers within 7 days of the baseline visit.
- •- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
- •- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- •- Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma (defined by an ACQ-5 score =1.5 or a history of = 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for > 24 hours).
- •- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- •Please see Protocol Section 4.2 for the full list of exclusion criteria.
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