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

Study Description

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Brief Summary:

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 receiving stable standard-of-care medications.

Condition or disease	Intervention/treatment	Phase
Systemic Lupus Erythematosus (SLE)	Drug: Placebo; Drug: Dapirolizumab pegol (DZP)	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	182 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
Actual Study Start Date :	June 2, 2016
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	November 2018

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Standard-of-care + Placebo; Placebo in a specified sequence for a total of 24 weeks	Drug: Placebo; Solution for infusion, 0,9% saline
Experimental: Standard-of-care + DZP dose 1; Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP); Solution for infusion
Experimental: Standard-of-care + DZP dose 2; Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP); Solution for infusion
Experimental: Standard-of-care + DZP dose 3; Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP); Solution for infusion

Outcome Measures

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Primary Outcome Measures :

1. Percentage of subjects with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :

1. The percentage of subjects with BICLA response in the individual dose groups at Week 24 [ Time Frame: Week 24 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by 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 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 70 Study Locations

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators

Study Director:	UCB Cares	+1 844 599 2273 (UCB)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier:	NCT02804763 History of Changes
Other Study ID Numbers:	SL0023; 2015-004457-40 ( EudraCT Number )
First Posted:	June 17, 2016
Last Update Posted:	January 17, 2018
Last Verified:	January 2018

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):

Systemic Lupus Erythematosus (SLE); Dapirolizumab Pegol (DZP)

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases