EUCTR2019-002933-12-IT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 - ADvocate2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Dermira, Inc
- 入组人数
- 400
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
- •- 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 a highly effective contraceptive during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.
- •-Male patients must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a female of child bearing potential
- •- 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:
- •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 phosphodiesterase-4 inhibitors such as crisaborole 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-gamma, 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. 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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