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

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

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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)