A MULTI-CENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY FOLLOWED BY AN EXTENSION PERIOD EVALUATING THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

CB Biopharma SPRL,0 个研究点目标入组 26 人开始时间: 2017年3月13日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written
•Informed Consent form is signed and dated by the subject or legal representative prior to the
•initiation of any study-specific assessment at Screening (Visit 1).
•2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand
•and complete diaries), visit schedule, and medication intake according to the judgment of the
•Investigator.
•3. Subject (male or female) is ≥18 years of age at Screening (Visit 1).
•4. Subject has a bodyweight of ≥50kg and ≤160kg.
•5. Adequate reading and writing abilities (in native language) such that the subject can
•comprehend and answer the questions on the subject completed assessments.
•6. The subject has SLE diagnosed by a physician, confirmed by the SLICC Classification
•Criteria for SLE.
•The subject has moderate to severe SLE disease activity as demonstrated by BILAG 2004

•1. Subject has previously been randomized in this study or has previously participated in a DZP
•clinical study.
•2. Subject has any medical or psychiatric condition that, in the opinion of the Investigator,
•could jeopardize or would compromise the subject’s ability to participate in this study.
•3. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
•study or within 3 months following their final dose of study drug.
•4. Subject has a history of malignancy, except the following treated cancers: cervical carcinoma
•in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
•5. Subject has a mixed connective tissue disease, scleroderma, and/or overlap syndromes of
•Subjects with SLE and secondary Sjögren’s syndrome are permitted provided they meet
•the eligibility criteria. ETC

发起方

CB Biopharma SPRL,