2023-503692-24-00招募中3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 87
- 主要终点
- Stage 1: Number of participants with CLA-IGA-R erythema response at Week 24; number of participants with CLASI-70 response at Week 24. Stage 2: Number of participants with CLASI-70 response at Week 24; CLA-IGA-R erythema response at Week 24 for the US and CLASI-70 response for EU/ROW.
研究概览
简要总结
Stage 1: To assess the efficacy of anifrolumab compared with placebo on skin manifestations in participants with CLE at Week 24. Stage 2: To demonstrate the superiority of anifrolumab to placebo on skin manifestations in participants with CLE at Week 24.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety Follow-up Period (12 weeks) – Stage 1 and Stage 2
- 盲法
- None
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
- 是
入选标准
- •Male and/or female participant must be 18 to 70 years of age inclusive, at the time of signing the ICF.
- •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. • CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R OMC score of ≥ 1 at Screening and confirmed at randomization. • Inadequate response or intolerant to antimalarial therapy. - At least one antimalarial agent used for at least 12 weeks (not continuous is acceptable) prior to Screening. Participants must be on a stable dose of antimalarial agent for at least 2 weeks prior to ICF signature. OR - Previously documented discontinuation of antimalarial agents due to poor tolerability and/or side effects. In case an antimalarial treatment had not been initiated due to medical reasons (in particular the presence of medical contraindications), then at least one of the following medications for CLE must have been tried any time before Screening: • Topical calcineurin inhibitors, administered for ≥ 3 months. • Systemic glucocorticoids taken for ≥ 6 weeks. • A conventional immunosuppressant, including, azathioprine, mycophenolate mofetil (or mycophenolic acid), retinoids, dapsone, or methotrexate administered for ≥ 3 months.
- •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. • No history of latent TB prior to initial Screening Visit. • The participant must undergo an IFN-γ release assay IGRA (e.g., QFT-G test) test for TB.
- •Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening as per local guidelines (Pap smear or HPV tests) with a normal test result within 2 years prior to randomization.
- •Participants should have a COVID-19 negative antigen or PCR test result as per local policies at Screening. They should also not have had known or suspected COVID-19 exposure within 2 weeks prior to Screening based on the COVID-19 questionnaire. If there is a known or suspected exposure, a participant must be negative upon a test obtained 2 weeks after known or suspected exposure and must remain asymptomatic for inclusion in the study.
排除标准
- •History or evidence of suicidal ideation.
- •Any clinical cytomegalovirus (CMV) or Epstein-Barr virus infection that has not been completely resolved.
- •Clinically significant chronic infection within 8 weeks prior to signing the ICF or any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF.
- •COVID-19 infection: • History of severe COVID-19 infection or any prior COVID-19 infection with documented long COVID-19 and/or clinically significant unresolved complications due to COVID-19 infection. • Mild/asymptomatic COVID-19 infection within the last 6 weeks prior to first dosing at the discretion of the Investigator.
- •Participants who do not meet the study restrictions for using all biologics, directly acting cytotoxic B cell-depleting therapies (eg, rituximab), and investigational product for CLE.
- •A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.
- •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.
- •Severe or life-threatening SLE.
- •Active SLE or Sjögren’s Syndrome.
- •Any active skin conditions other than CLE that may interfere with the study.
- •History of recurrent infection requiring hospitalization and IV antibiotics.
- •Known history of primary immunodeficiency, splenectomy, or any underlying condition that makes the participant prone to infection, or a positive result for HIV infection at Screening.
- •Confirmed positive test for hepatitis B serology.
- •Presence of active hepatitis C infection.
- •Any severe case of herpes zoster infection prior to randomization.
结局指标
主要结局
Stage 1: Number of participants with CLA-IGA-R erythema response at Week 24; number of participants with CLASI-70 response at Week 24. Stage 2: Number of participants with CLASI-70 response at Week 24; CLA-IGA-R erythema response at Week 24 for the US and CLASI-70 response for EU/ROW.
Stage 1: Number of participants with CLA-IGA-R erythema response at Week 24; number of participants with CLASI-70 response at Week 24. Stage 2: Number of participants with CLASI-70 response at Week 24; CLA-IGA-R erythema response at Week 24 for the US and CLASI-70 response for EU/ROW.
次要结局
- Stage 1: - Number of participants with CLA-IGA-R OMC response at Week 24; - Number of participants with CLA-IGA-R OMC complete response at Week 24; - Number of participants with CLA-IGA-R follicular activity response at Week 24
- Stage 1: - Number of participants with CLA-IGA-R response at Week 24; - Percent change from baseline at Week 24 in total erythema score; - Percent change from baseline at Week 24 in total scale/hypertrophy score.
- Stage 1: - Number of participants with CLA-IGA-R erythema response at Week 12; - Number of participants with CLA-IGA-R OMC response at Week 12; - Number of participants with CLASI-70 response at Week 12.
- Stage 1 and Stage 2: Change from baseline at Week 24 in Skindex-29+3 domain scores.
- Stage 2: - Percent change from baseline at Week 24 in total erythema score; - Percent change from baseline at Week 24 in total scale/hypertrophy score; - CLA-IGA-R OMC response at Week 24 and CLA-IGA-R OMC complete response at Week 24.
- Stage 2: - Number of participants with CLA IGA R erythema response at Week 12; - Number of participants with CLA IGA R OMC response at Week 12; - Number of participants with CLASI-70 response at Week 12.
- Stage 2: - Number of participants with CLA IGA R response at Week 24; - Number of participants with CLA IGA R follicular activity response at Week 24; - Participants with ≥ 7-point reduction from baseline in CLASI-A total score (yes/no) at Week 24.
- Stage 2: - Number of participants who are primary endpoint responders (CLA-IGA-R erythema response at Week 24) and maintain CLA-IGA-R erythema response up to and including Week 52; - Number of participants who are primary endpoint responders (CLASI-70 response at Week 24) and maintain CLASI-70 response up to and including Week 52.
- Stage 1 and Stage 2: Pharmacokinetic (PK) assessment (Ctrough) for subcutaneously administered anifrolumab in participants with CLE will be performed.
- Stage 1 and Stage 2: Pharmacodynamic (PD) assessment for subcutaneously administered anifrolumab in participants with CLE will be performed.
- Stage 1 and Stage 2: The immunogenicity of subcutaneously administered anifrolumab in participants with CLE will be evaluated.
- Stage 1 and Stage 2: Number of participants with adverse events.
研究者
Clinical Study Information Centre
Scientific
AstraZeneca AB
研究点 (87)
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