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

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ClinicalTrials.gov Identifier: NCT02804763
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804763


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Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
More Information
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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    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Systemic Lupus Erythematosus (SLE)
Dapirolizumab Pegol (DZP)

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs