None listed
Conditions
Interventions
Study drug will be administered by iv infusion every 4 weeks during Part 1 of the
study. Subjects who withdraw early from the 24-week Double-Blind Treatment Period (Part 1)
will enter an 8-week
Sponsors
UCB Biopharma SPRL,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 SLE. Subjects with SLE and secondary Sjögren’s syndrome are permitted provided they meet the eligibility criteria. ETC
Countries
Argentina, Bulgaria, Chile, Colombia, Germany, Mexico, Peru, Russian Federation, Spain, United States
Contacts
Public ContactNarda Malpartida
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed