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 : December 16, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus (SLE) | Drug: Placebo Drug: Dapirolizumab pegol (DZP) | Phase 2 |
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 19, 2018 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo in a specified sequence for a total of 24 weeks
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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 |
- 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 ]
- The percentage of subjects with BICLA response in the individual dose groups at Week 24 [ Time Frame: Week 24 ]

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

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

Study Director: | UCB Cares | +1 844 599 2273 (UCB) |
Responsible Party: | UCB Biopharma S.P.R.L. |
ClinicalTrials.gov Identifier: | NCT02804763 |
Other Study ID Numbers: |
SL0023 2015-004457-40 ( EudraCT Number ) |
First Posted: | June 17, 2016 Key Record Dates |
Last Update Posted: | December 16, 2019 |
Last Verified: | December 2019 |
Systemic Lupus Erythematosus (SLE) Dapirolizumab Pegol (DZP) |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |