NCT02277743已完成3 期
A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 671
- 主要终点
- Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years or older
- •Chronic AD (according to American Academy of Dermatology Consensus Criteria Eichenfield 2014) that has been present for at least 3 years before the screening visit;
- •Eczema Area and Severity Index (EASI) Score ≥16 at the screening and baseline visits;
- •Investigator's Global Assessment (IGA) Score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits;
- •≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;
- •Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g, because of important side effects or safety risks).
排除标准
- •Participation in a prior Dupilumab clinical study;
- •Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever was longer, before the baseline visit;
- •Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 4 weeks of study treatment:
- •Immunosuppressive/ immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.);
- •Phototherapy for AD
- •Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit;
- •Treatment with biologics as follows:
- •Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever was longer
- •Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer
- •Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
- •Planned or anticipated use of any prohibited medications and procedures during study treatment;
- •Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
- •Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: Participants might be rescreened after infection resolves;
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment;
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
- •Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
- •Participant was a member of the investigational team or his/her immediate family;
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
- •Women unwilling to use adequate birth control, if of reproductive potential and sexually active.
- •Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
研究组 & 干预措施
Placebo
Experimental
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.
干预措施: Placebo (for Dupilumab) (Drug)
Dupilumab 300 mg once weekly (qw)
Experimental
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
干预措施: Dupilumab (Drug)
Dupilumab 300 mg every 2 weeks (q2w)
Experimental
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
干预措施: Dupilumab (Drug)
Dupilumab 300 mg every 2 weeks (q2w)
Experimental
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
干预措施: Placebo (for Dupilumab) (Drug)
结局指标
主要结局
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
时间窗: Week 16
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.
次要结局
- Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4(Baseline to Week 4)
- Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16(Week 16)
- Change From Baseline in Percent Body Surface Area (BSA) to Week 16(Baseline to Week 16)
- Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2(Baseline to Week 2)
- Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16(Week 16)
- Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16(Baseline to Week 16)
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16(Baseline to Week 16)
- Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16(Week 16)
- Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16(Baseline to Week 16)
- Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16(Baseline to Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16(Baseline to Week 16)
- Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16(Baseline to Week 16)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16(Baseline to Week 16)
- Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2(Baseline to Week 2)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16(Baseline up to Week 16)
- Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16(Baseline to Week 16)
- Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16(Baseline up to Week 16)
- Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment(Baseline up to Week 16)
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