2022-500777-14-00已完成2 期
A phase 2b, randomised, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered LEO 138559 in adult subjects with moderate-to-severe atopic dermatitis (AD)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 42
- 主要终点
- Percent change in EASI score from baseline to Week 16
研究概览
简要总结
To compare the efficacy of 4 different dosage regimens of LEO 138559 with placebo in subjects with moderate-to-severe AD.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment Period
- 盲法
- Double (Investigator, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18-75 years old (both included) at screening (Visit 1).
- •At screening, diagnosis of - AD as defined by the Hanifin and Rajka (1980) criteria for AD. History of AD for ≥1 year.
- •Subjects who have a recent history (within 12 months before screening) with documented inadequate response to treatment with TCS (±TCI as appropriate) or for whom these topical AD treatments are medically inadvisable (e.g. due to important side effects or safety risks).
- •EASI score ≥12 at screening and ≥16 at baseline.
- •vIGA-AD score ≥3 at screening and baseline.
- •BSA of AD involvement ≥10% at screening and baseline.
- •ADSD Worst Itch score (weekly average) ≥4 at baseline.
排除标准
- •History of clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject’s ability to participate in the trial. Clinically significant infections are defined as: - a systemic infection. - a serious skin infection requiring parenteral (IV or intramuscular) antibiotics, antiviral, or antifungal medication.
- •Receipt of blood products within 28 days prior to screening.
- •Treatment with: - Any marketed or investigational biologic agents within 3 months or 5 half-lives, whichever is longer, prior to baseline. - Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
- •Treatment with TCS, TCI, topical PDE-4 inhibitors, topical JAK inhibitors, or other medicated topical treatments within 7 days prior to baseline
- •Receipt of live attenuated vaccines 30 days prior to baseline.
- •Non-serious skin infection within 7 days prior to baseline.
- •Presence of hepatitis B or C infection at screening.
- •History of HIV infection or positive HIV serology at screening.
- •Evidence of active or latent tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment.
- •Women who are pregnant or breastfeeding.
- •Previous exposure to fezakinumab (anti-IL-22 Ab).
- •Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), corticosteroids (steroid eyedrops and inhaled or intranasal steroids are allowed), or JAK inhibitors within 28 days or 5 half-lives prior to baseline, whichever is longer.
- •Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 4 weeks prior to baseline.
结局指标
主要结局
Percent change in EASI score from baseline to Week 16
Percent change in EASI score from baseline to Week 16
次要结局
- Number of TEAEs recorded for each subject from baseline to Week 16.
研究者
LEO Pharma Clinical Trials mailbox
Scientific
Leo Pharma A/S
研究点 (42)
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