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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02804763
• Date of registration: 14/06/2016
• Prospective Registration: No
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
• Scientific 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
• Date of first enrolment: June 2, 2016
• Target sample size: 182
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02804763
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Chile, Colombia, Germany, Hungary, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus (SLE)

Intervention(s)

Drug: Dapirolizumab pegol (DZP)

Drug: Placebo

Primary Outcome(s)

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(s)

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

Secondary ID(s)

2015-004457-40

SL0023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors