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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 : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE June 2, 2016
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Percentage of subjects with BICLA response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24 [ Time Frame: Week 24 ]
Change History Complete list of historical versions of study NCT02804763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
The percentage of subjects with BICLA response in the individual dose groups at Week 24 [ Time Frame: Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus (SLE)
Intervention  ICMJE
  • Drug: Placebo
    Solution for infusion, 0,9% saline
  • Drug: Dapirolizumab pegol (DZP)
    Solution for infusion
Study Arms  ICMJE
  • Placebo Comparator: Standard-of-care + Placebo
    Placebo in a specified sequence for a total of 24 weeks
    Intervention: Drug: Placebo
  • Experimental: Standard-of-care + DZP dose 1
    Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks
    Intervention: Drug: Dapirolizumab pegol (DZP)
  • Experimental: Standard-of-care + DZP dose 2
    Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks
    Intervention: Drug: Dapirolizumab pegol (DZP)
  • Experimental: Standard-of-care + DZP dose 3
    Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks
    Intervention: Drug: Dapirolizumab pegol (DZP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2017)
182
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
160
Actual Study Completion Date  ICMJE November 15, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Chile,   Colombia,   Germany,   Hungary,   Mexico,   Peru,   Poland,   Romania,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804763
Other Study ID Numbers  ICMJE SL0023
2015-004457-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP