A Multicenter Randomized Double-blind Placebo-controlled Parallelgroup Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants with Moderately to Severely Active Systemic Lupus Erythematosus

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Systemic Lupus Erythematosus
  • Age: Between 16 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. 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
    2. Body weight =40kg and =160kg
    3. A male study participant must agree to use contraception
    4. A female study participant is eligible to participate if she is not pregnant, not breastfeeding and agree to use contraception
    5. Must provide written informed consent

You may not be eligible for this study if the following are true:

    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
    2. Study participant has moderate to severe disease activity (as defined per inclusion criterion 2.d) at the Screening Visit (V1) due to an acute flare but does not fulfill at least one of the following criteria in addition to the Screening Visit
      • One or more additional disease flare within the last 24 weeks prior to Screening (as per medical record) OR
      • Anti-dsDNA positivity in combination with C3 < LLN as per central laboratory OR
      • Complement C4 < LLN as per central laboratory OR
      • African-American OR
      • Age < 25 years
    3. Study participant has a history of chronic alcohol or drug abuse within the previous 24 weeks.
    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
    6. Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
    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
    10. Study participants with a history of catastrophic APS or saddle pulmonary embolism
    11. Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device
    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 syndrome of these diseases with SLE



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