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

• ClinicalTrials.gov Identifier: NCT02804763
• Recruitment Status: Completed
• First Posted: June 17, 2016
• Last Update Posted: July 9, 2019
• Sponsor: UCB Biopharma S.P.R.L.
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Description

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.

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo in a specified sequence for a total of 24 weeks	Drug: Placebo; Solution for infusion, 0,9% saline
Experimental: 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: 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: 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

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

• 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

  Show 71 Study Locations

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators

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

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: July 9, 2019
• Last Verified: July 2019

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; Immunoglobulin Fab Fragments; Immunologic Factors; Physiological Effects of Drugs