A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 339
- 试验地点
- 188
- 主要终点
- Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
研究概览
简要总结
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in adults with chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The study has a randomized, 24-week double-blind, placebo-controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of anifrolumab. The double-blind study period will be followed by an open-label, uncontrolled treatment period in which all participants will receive treatment with anifrolumab from Week 24 to Week 51. After the open-label treatment period, participants will enter a 12-week Safety Follow-up Period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
- •CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
- •Inadequate response or intolerant to antimalarial therapy.
- •Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
- •Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •History or evidence of suicidal ideation.
- •Severe or life-threatening Systemic lupus erythematosus (SLE).
- •Active SLE or Sjögren's Syndrome.
- •Any active skin conditions other than CLE that may interfere with the study.
- •History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).
- •History of recurrent infection requiring hospitalization and IV antibiotics.
- •COVID-19 infection.
- •Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
- •At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Anifrolumab
Participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51.
干预措施: Anifrolumab (Combination Product)
Placebo
Participants will receive placebo as a SC injection from Week 0/Day 1 up to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
时间窗: At Week 24
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
次要结局
- Time from IP start date to CLASI-50 response.(From Week 0/Day 1 up to Week 24)
- Time from IP start date to CLASI-70 response.(From Week 0/Day 1 up to Week 24)
- Change from baseline in total CLASI-A score(At Week 24)
- Number of participants with CLASI-70 response(At Week 12)
- Number of participants with ≥ 7-point reduction from baseline in CLASI-A total score(At Week 12)
- Number of participants with CLASI-50 response(At Week 12 and Week 24)
- Number of participants who are sustained CLASI-70 responders(Up to Week 52)
- Serum trough (pre-dose) concentrations of anifrolumab(Double-blind: Pre-dose on Day 1 (Week 0), Weeks 1, 4, 12, 24; Open-label: Weeks 40, and 52 or early discontinuation visit [EDV] and follow-up visit (13 Weeks after last dose))
- Number of participants with positive antidrug antibody(Double-blind: Pre-dose on Day 1 (Week 0), Weeks 4, 12, and 24; Open-label: Pre-dose on Weeks 40, and 52 or EDV and follow-up visit (13 weeks after last dose))
- Percent change from baseline in suppression of the Interferon 21-gene(Double-blind: Day 1 (Week 0), Week 1, 4, 12, and 24; Open-label; Week 40 and 52 or EDV and follow-up visit (13 weeks after last dose))
- Change from baseline in Skindex-29+3 Symptom domain scores(At Week 24)
- Change from baseline in Skindex-29+3 Emotion domain scores(At Week 24)
- Change from baseline in Skindex-29+3 Function domain scores(At Week 24)
- Change from baseline in Skindex-29+3 Lupus-Specific domain scores(At Week 24)
- Change from baseline in Skindex-29+3 Total score(At Week 24)