PER-046-20招募中未知
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TOEVALUATE THE EFFICACY AND SAFETY OFDAPIROLIZUMAB PEGOL IN STUDY PARTICIPANTS WITHMODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUSERYTHEMATOSUS
CB Biopharma SRL,0 个研究点目标入组 0 人开始时间: 2020年11月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
入选标准
- •1. Study participant must be ≥16 years of age, unless restricted by local regulation, at the time
- •of signing the Informed Consent form (ICF).
- •Type of participant and disease characteristics
- •2. Study participants who have moderate to severe disease activity due to either persisting
- •active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsingremitting
- •SLE despite stable SOC medication defined as:Diagnosed with SLE at least 24
- •weeks before study entry by a qualified physician (eg, rheumatologist, internal medicine
- •expert, nephrologist, or dermatologist)
- •3. Body weight ≥40kg and ≤160kg.
- •4. Female and/or male
- •A male study participant must agree to use contraception, as detailed in Section 10.4, during
- •the Treatment Period and for at least 17 weeks after the final dose of study medication and
- •refrain from donating sperm during this period.
- •A female study participant is eligible to participate if she is not pregnant, not breastfeeding,
- •and at least 1 of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP) as defined in Section 10.4 of the
- •protocol, or
- •A WOCBP who agrees to follow the contraceptive guidance in Section 10.4 of the final
- •protocol during the treatment period and for at least 17 weeks after the final dose of study
- •medication.
- •Informed consent
- •5. Capable of giving signed informed consent as described in Section 10.1.3, which includes
- •compliance with the requirements and restrictions listed in the ICF and in this protocol.
排除标准
- •Study participants are excluded from the study if any of the following criteria apply:
- •Medical conditions
- •1. Study participant has any medical or psychiatric condition (including conditions due to
- •neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would
- •compromise the study participant’s ability to participate in this study. This includes study
- •participants with a life threatening condition (eg, CTCAE grade 4 conditions, CAPS, acute
- •severe renal failure, acute severe central nervous system [CNS] manifestations)
- •2. Study participant has moderate to severe disease activity as defined per inclusion criterion 2d
- •at study entry due to an acute flare but does not fulfill at least one of the following criteria at
- •the Screening Visit:
- •≥1 additional disease flare within the last 24 weeks prior to Screening (as per medical
- •Evidence for anti-dsDNA antibodies in combination with C3 Complement C4 African-American OR
- •3. Study participant has a history of chronic alcohol or drug abuse within the previous
- •4. Study participant has a known hypersensitivity to any components of DZP including PEG or
- •comparative drugs (and/or an investigational device) as stated in this protocol.
- •5. Study participant has a history of an anaphylactic reaction to parenteral administration of
- •contrast agents, human or murine proteins, or monoclonal antibodies. This includes reactions
- •due to latex allergy.
- •6. Study participant has a history of malignancy, except the following treated cancers: cervical
- •carcinoma in situ (after complete resection (eg. curettage, electrodesiccation) not later than
- •4 weeks prior to study entry), basal cell carcinoma, or dermatological squamous cell
- •carcinoma (after complete resection not later than 24 weeks prior to study entry).
- •7. Study participants who have had major surgery (including joint surgery) within the 24 weeks
- •prior to Screening, or planned surgery within 24 weeks after entering the study.
- •8. Study participants who have had significant blood loss or have donated or received 1 or more
- •units (450mL) of blood within 30 days prior to the Screening Visit or have donated plasma or
- •platelets within 14 days prior to the Screening Visit.
- •9. Study participants with a history of thromboembolic events within 52 weeks of Screening
- •(Visit 1), including but not limited to the following: deep venous thrombosis, pulmonary
- •embolism, cortical sinus thrombosis, myocardial infarction, stroke, transient ischemic attack,
- •or arterial insufficiency causing digital gangrene or tissue necrosis.
- •10. Study participants with a history of catastrophic APS or saddle pulmonary embolism.
- •11. Study participant has a vascular graft, valvular heart disease, atrial fibrillation, or any other
- •heart rhythm disorder associated with an increased risk for thromboembolic events.
- •12. Study participant has a BILAG 2004 Grade A in the musculoskeletal system due to severe
- •arthritis only AND no BILAG 2004 Grade A or B in any other organ system AND no current
- •(within the past 4 weeks) evidence for synovitis based on imaging methods such as magnetic
- •resonance imaging or doppler-sonography.
- •13. Study participant has a mixed connective tissue disease, scleroderma, and/or overlap
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