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A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

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UCB

Status and phase

Completed
Phase 2

Conditions

Systemic Lupus Erythematosus (SLE)

Treatments

Drug: Placebo
Drug: Dapirolizumab pegol (DZP)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02804763
SL0023
2015-004457-40 (EudraCT Number)

Details and patient eligibility

About

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

182 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo in a specified sequence for a total of 24 weeks
Treatment:
Drug: Placebo
DZP dose 1
Experimental group
Description:
Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks
Treatment:
Drug: Dapirolizumab pegol (DZP)
DZP dose 2
Experimental group
Description:
Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks
Treatment:
Drug: Dapirolizumab pegol (DZP)
DZP dose 3
Experimental group
Description:
Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks
Treatment:
Drug: Dapirolizumab pegol (DZP)

Trial documents
2

Trial contacts and locations

71

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Data sourced from clinicaltrials.gov

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