Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma S.P.R.L.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
Moderate to severe SLE disease activity
Evidence for at least 1 of the following SLE markers:
* Anti-dsDNA antibodies confirmed by central laboratory or
* Low complement confirmed by central laboratory or
* Antinuclear antibody (ANA) titer of \>= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory
The subject is receiving stable SLE standard-of-care medication
You may not be if
Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE
Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
New or worsening Class III or IV lupus nephritis
Chronic kidney failure stage 3b
Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)
Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection
Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug
History of thromboembolic events within 12 months of screening
Subject has used protocol defined prohibited medications
Clareo Health | A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
