NL-OMON51523尚未招募3 期
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis - IRIS
Astra Zeneca0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 18 through 70 years at the time of Screening. 2. Fulfills updated 2019
- •SLE criteria. 3. Positive ANA, anti-dsDNA, or anti-Sm test result in sample
- •obtained during Screening. 4. Urine protein to creatinine ratio > 1 mg/mg
- •(113.17 mg/mmol) (mean of 2 spot UPCR [FMV] samples obtained during Screening).
- •5. Active proliferative LN Class III or IV either with or without the presence
- •of Class V (excluding pure Class III[C], IV-S[C], or IV-G[C]) according to the
- •2003 ISN/RPS classification based on a renal biopsy obtained within 6 months
- •prior to signing the ICF or during Screening Period. 6. eGFR >= 35 mL/min/1.73
- •m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration
- •formula). 7. Adequate peripheral venous access. 8. Chest radiograph (obtained
- •during Screening or within 12 weeks prior to signing of the informed consent)
- •or a CT scan of the chest (within 12 weeks of signing the informed consent)
- •that meets all of the following criteria: No evidence of current active
- •infection (eg, pneumonia, TB) or previous TB; No evidence of malignancy; No CS
- •abnormalities (unless due to SLE). 9. Meets all of the following TB criteria:
- •No signs or symptoms of active TB prior to or during any Screening visit; No
- •medical history or past physical examinations suggestive of active TB; A chest
- •radiograph during the Screening Period or within 12 weeks prior to signing the
- •ICF with no evidence of active or signs of prior TB infection; No recent
- •contact with a person with active TB OR if there has been such contact,
- •referral to a physician specializing in TB to undergo additional evaluation
- •prior to Week 0 (Day 1) (documented comprehensively in source) and, if
- •warranted, receipt of appropriate treatment for latent TB at or before the
- •first administration of study intervention; No history of latent TB prior to
- •signing the ICF, with the exception of latent TB with documented completion of
- •appropriate treatment.The participant must undergo an IGRA (eg, QFT-G test)
- •test for TB obtained from the study central laboratory at Screening with
- •results in line with protocol specified rules. 10. Negative SARS-Cov-2 RT-PCR
- •test result at Screening and no known or suspected COVID-19 infection or
- •exposure between signing the ICF and Week 0 (Day 1). There must be a minimum of
- •2 weeks between the 2 tests at Screening and Week 0 (Day 1). 11. Body weight >=
- •40.0 kg. 12. Females with an intact cervix must have documentation of a Pap
- •smear with no documented malignancy (eg, CIN III, carcinoma in situ, or
- •adenocarcinoma in situ) within 2 years prior to Week 0 (Day 1) 13.
- •Contraceptive use by men or women should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •studies (as described in protocol).
排除标准
- •1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6
- •months prior to signing the ICF or during Screening. 2. History of dialysis
- •within 12 months prior to the ICF or expected need for renal replacement
- •therapy (dialysis or renal transplant) within a 6-month period after
- •enrollment. 3. History of, or current renal diseases (other than LN) that, in
- •the opinion of the Investigator, could interfere with the LN assessment and
- •confound the disease activity assessment (eg, diabetic nephropathy) 4. History
- •of recurrent infection requiring hospitalization and/or IV antibiotics (eg, 2
- •or more of the same type of infection over the previous 52 weeks). 5. Known
- •history of a primary immunodeficiency, splenectomy, or any underlying condition
- •that predisposes the participant to infection, or a positive result for HIV
- •confirmed by the central lab at Screening - an HIV test must be performed
- •during Screening, and the result should be available prior to Week 0 (Day 1).
- •6. At Screening, confirmed positive test for hepatitis B serology, as confirmed
- •by central lab, for: HBsAg or HBcAb and HBV DNA detected above the LLOQ by
- •reflex testing by the central lab at Screening. Participants who are HBcAb
- •positive at Screening will be tested every 3 months for HBV DNA. To remain
- •eligible for the study, the participant*s HBV DNA levels must remain below the
- •LLOQ as per the central lab. 7. Positive test for hepatitis C antibody as
- •confirmed by the central lab. 8. Any severe case, as defined by study
- •guidelines, of HZ infection at any time prior to Week 0 (Day 1). 9. Any
- •clinical CMV or EBV infection that has not completely resolved within 12 weeks
- •prior to the ICF. 10. Opportunistic infection (see Section 8.3.8.2 of protocol)
- •requiring hospitalization or IV antimicrobial treatment within 3 years prior to
- •the ICF. 11. Clinically significant chronic infection (ie, osteomyelitis,
- •bronchiectasis, etc) within 8 weeks prior to signing the ICF (chronic nail
- •infections are allowed) or any infection requiring hospitalization or treatment
- •with IV anti-infectives not completed at least 4 weeks prior to the ICF. 12.
- •Any infection requiring oral anti-infectives (including antivirals) within 2
- •weeks prior to Week 0 (Day 1). 13. History of cancer, apart from: Squamous or
- •basal cell carcinoma of the skin treated with documented success of curative
- •therapy >= 3 months prior to Week 0 (Day 1); Cervical cancer in situ treated
- •with apparent success with curative therapy >= 1 year prior to Week 0 (Day 1).
- •15. Prior receipt of anifrolumab. 16. Previous receipt of >*2 investigation
- •treatments (other than anifrolumab) for LN or SLE since time of diagnosis and
- •through the ICF. 17. Known intolerance to <= 1.0 g/day of MMF. 18. Receipt of
- •any commercially available biologic agent within 5 half-lives (see Appendix O
- •for a complete list) prior to signing of the ICF. 19. Receipt of any of the
- •following prior to signing the ICF (refer to Appendix O of protocol for a
- •complete list): Receipt of B cell-depleting therapy <= 26 weeks prior to the ICF
- •or if therapy was administered > 26 weeks ago, if absolute B cell count is
- •below the lower limit of normal or is baseline value prior to receipt of B
- •cell-depleting therapy (whichever is lower) 20. A known history of allergy or
- •reaction to any component of the
研究者
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