PER-048-15已完成未知
A PHASE II MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGE FINDING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ALX-0061 ADMINISTERED SUBCUTANEOUSLY IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
Ablynx,0 个研究点目标入组 6 人开始时间: 2016年3月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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 65（—）
入选标准
- •1.Adult ≥ 18 and < 65 years.2.Diagnosis of SLE and fulfill 1997 ACR or 2012 SLICC classification criteria for at least 6 months prior to screening.3.Have moderate to severe active SLE, defined by a SLEDAI-2K score ≥ 6.4.Have at least one A or one B score on BILAG 2004 criteria for the mucocutaneous and/or musculoskeletal system.5.Have seropositive disease at screening for ANA ≥ 1:80 and/or anti-dsDNA (≥ 30 IU/mL).6.Subject at least must be on one or more of the following treatments for SLE:a.oral corticosteroids. b.antimalarials. c.immunosuppressants; either alone or in combination with corticosteroids and/or hydroxychloroquine.7. immunosuppressants, the last dose should have been received more than 4 weeks prior to baseline; leflunomide or hydroxychloroquine treatment-free period of at least 12 weeks.8.angiotensin-converting-enzyme (ACE) inhibitor or angiotensin receptor blocker, the dose should have been stable for 4 weeks prior to baseline.
- •9.Chest X-ray no evidence of malignancy, infection, or abnormalities suggestive of tuberculosis.10.Are considered eligible according to the following TB screening criteria:a.no history of latent or active.
- •b.no signs or symptoms suggestive of active TB .c.Have had no recent close contact with a person with active TB.
- •d.negative interferon gamma release assay.e.chest X-ray with no evidence of current active TB or old inactive TB.
- •11.Female subjects of childbearing potential (excluding postmenopausal women, sterilized, ovariectomized and hysterectomized women) must have a negative pregnancy test and must agree to use two generally accepted adequate contraceptive. Male subjects must use condoms for the duration of the study and for at least 3 months after last dosing.12.Capability to comprehend and willingness to sign an ICF.13.An understanding, ability and willingness to adhere to the study visit schedule and other protocol requirements.
排除标准
- •1.A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal.2.ystemic inflammatory disease other than SLE.3.Infection treated with antibiotics, antivirals, or antifungals within 2 to 4 weeks prior to baseline.4.Active or recurrent viral infection
- •5.history of, or current, class III or IV congestive heart failure , as defined by NYHA; history of unstable angina pectoris, myocardial infarction, cerebrovascular accident, thromboembolic event.6.active lupus nephritis. 7.lupus-related central neurological problems or severe CNS disease. 8.drug-induced lupus.9.history of demyelinating diseases.10.diverticulitis or symptoms of acute diverticulitis.
- •11.malignancy or lymphoproliferative disease.
- •12.transplanted organ or received stem cell transplantation.
- •13.Major surgery.14.treatment with i.v. immunoglobulins, cyclophosphamide or tacrolimus within 12 months prior to baseline. 15.Have received i.v., intra-articular (i.a.), intramuscular (i.m.) or high dose oral corticosteroids during the 4 weeks prior to baseline.16.known hypersensitivity to the active product or any excipient of the study drug.17.Have received approved or investigational biological therapies within 6 months or 5 half-lives.18.Have received non-biological investigational therapies within 4 weeks or 5 half lives.19.Have received prior therapy blocking the IL-6 pathway or Janus kinase (JAK) inhibitors.20.Abnormality in screening laboratory test results. 21.Positive screening for hepatitis B, hepatitis C or HIV 22.presence of alcohol or drug abuse.23.Blood donation (> 500 mL) or a comparable blood loss within 3 months prior to baseline. 24.Planned donation of germ cells, blood, organs, bone marrow.25.planning to become pregnant during the study or within 3 months after last dosing.26.Pregnant woman or female subjects who are breastfeeding.27.anaphylactic reactions.28.live, attenuated vaccine within 3 months before.29.Subject is considered by the Investigator to be an unsuitable candidate for the study.
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