A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

May 28, 2026 updated by: UCB Biopharma SRL

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

760

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sl0046 60002
      • Mendoza, Argentina
        • Sl0046 60029
      • Quilmes, Argentina
        • Sl0046 60003
      • Quilmes, Argentina
        • Sl0046 60022
      • San Juan, Argentina
        • Sl0046 60011
      • San Miguel de Tucumán, Argentina
        • Sl0046 60014
  • Belgium
      • Brussels, Belgium
        • Sl0046 40123
  • Bulgaria
      • Plovdiv, Bulgaria
        • Sl0046 40189
      • Sofia, Bulgaria
        • Sl0046 40380
  • Canada
      • Calgary, Canada
        • Sl0046 50374
      • Edmonton AB, Canada
        • Sl0046 50337
      • Rimouski, Canada
        • Sl0046 50259
      • Toronto, Canada
        • Sl0046 50045
  • Chile
      • Santiago, Chile
        • Sl0046 60018
      • Santiago, Chile
        • Sl0046 60015
  • China
      • Changchun, China
        • Sl0046 20291
      • Guangzhou, China
        • Sl0046 20019
      • Guilin, China
        • Sl0046 20290
      • Tianjin, China
        • Sl0046 20136
      • Wenzhou, China
        • Sl0046 20025
      • Wuhan, China
        • Sl0046 20180
      • Zhengzhou, China
        • Sl0046 20132
  • Colombia
      • Barranquilla, Colombia
        • Sl0046 60013
      • Barranquilla, Colombia
        • Sl0046 60019
      • Bogotá, Colombia
        • Sl0046 60006
      • Bogotá, Colombia
        • Sl0046 60027
      • Bucaramanga, Colombia
        • Sl0046 60016
      • Chía, Colombia
        • Sl0046 60007
      • Montería, Colombia
        • Sl0046 60031
  • Czechia
      • Prague, Czechia
        • Sl0046 40066
  • Germany
      • Cologne, Germany
        • Sl0046 40386
      • Freiburg im Breisgau, Germany
        • Sl0046 40072
      • Herne, Germany
        • Sl0046 40027
      • Leipzig, Germany
        • Sl0046 40078
      • Tübingen, Germany
        • Sl0046 40402
  • Greece
      • Athens, Greece
        • Sl0046 40378
      • Athens, Greece
        • Sl0046 40501
      • Crete, Greece
        • Sl0046 40377
      • Larissa, Greece
        • Sl0046 40507
  • Hungary
      • Budapest, Hungary
        • Sl0046 40412
      • Debrecen, Hungary
        • Sl0046 40411
      • Szeged, Hungary
        • Sl0046 40031
      • Székesfehérvár, Hungary
        • Sl0046 40499
  • Italy
      • Catania, Italy
        • Sl0046 40084
      • Milan, Italy
        • Sl0046 40448
  • Mexico
      • Chihuahua City, Mexico
        • Sl0046 50317
      • Cuernavaca, Mexico
        • Sl0046 50250
      • Guadalajara, Mexico
        • Sl0046 50249
      • León, Mexico
        • Sl0046 50271
      • Monterrey, Mexico
        • Sl0046 50251
      • Mérida, Mexico
        • Sl0046 50252
  • Peru
      • Lima, Peru
        • Sl0046 60023
      • Lima, Peru
        • Sl0046 60009
  • Philippines
      • Davao City, Philippines
        • Sl0046 20182
      • Makati, Philippines
        • Sl0046 20181
  • Poland
      • Bialystok, Poland
        • Sl0046 40482
      • Bydgoszcz, Poland
        • Sl0046 40119
      • Katowice, Poland
        • Sl0046 40398
      • Krakow, Poland
        • Sl0046 40502
      • Lublin, Poland
        • Sl0046 40151
      • Poznan, Poland
        • Sl0046 40044
      • Poznan, Poland
        • Sl0046 40090
      • Warsaw, Poland
        • Sl0046 40097
      • Warsaw, Poland
        • Sl0046 40098
      • Wroclaw, Poland
        • Sl0046 40397
      • Wroclaw, Poland
        • Sl0046 40481
  • Puerto Rico
      • Caguas, Puerto Rico
        • Sl0046 50671
  • Romania
      • Galati, Romania
        • Sl0046 40382
  • Serbia
      • Belgrade, Serbia
        • Sl0046 40393
      • Belgrade, Serbia
        • Sl0046 40461
  • South Korea
      • Incheon, South Korea
        • Sl0046 20108
      • Seoul, South Korea
        • Sl0046 20104
  • Spain
      • Barcelona, Spain
        • Sl0046 40160
      • Málaga, Spain
        • Sl0046 40341
      • Sabadell, Spain
        • Sl0046 40101
      • Vigo, Spain
        • Sl0046 40099
  • Taiwan
      • Taichung, Taiwan
        • Sl0046 20113
      • Taichung, Taiwan
        • Sl0046 20142
      • Taipei, Taiwan
        • Sl0046 20095
      • Taiyuan, Taiwan
        • Sl0046 20082
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Sl0046 50140
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Sl0046 50058
      • Tucson, Arizona, United States, 85704
        • Sl0046 50328
    • California
      • Beverly Hills, California, United States, 90210
        • Sl0046 50383
      • La Palma, California, United States, 90623-1730
        • Sl0046 50275
      • San Leandro, California, United States, 94578
        • Sl0046 50316
    • Colorado
      • Denver, Colorado, United States, 80230
        • Sl0046 50339
    • Florida
      • Brandon, Florida, United States, 33511
        • Sl0046 50239
      • Gainesville, Florida, United States, 32610
        • Sl0046 50362
      • Miami, Florida, United States, 33172
        • Sl0046 50681
      • Ormond Beach, Florida, United States, 32174
        • Sl0046 50059
      • Plantation, Florida, United States, 33324
        • Sl0046 50324
      • Tampa, Florida, United States, 33606
        • Sl0046 50329
      • Tampa, Florida, United States, 33614
        • Sl0046 50698
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Sl0046 50368
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Sl0046 50240
    • Kentucky
      • Hopkinsville, Kentucky, United States, 42240-1746
        • Sl0046 50474
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Sl0046 50285
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Sl0046 50015
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Sl0046 50219
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Sl0046 50273
    • New York
      • Canton, New York, United States, 13617
        • Sl0046 50366
      • Manhasset, New York, United States, 11030
        • Sl0046 50264
      • New York, New York, United States, 10032
        • Sl0046 50334
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Sl0046 50238
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Sl0046 50147
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Sl0046 50001
    • Texas
      • Colleyville, Texas, United States, 76034
        • Sl0046 50418
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Sl0046 50050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
  • The participant completed one of the parent studies within 4 weeks prior to entry to this study

Exclusion Criteria:

- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapirolizumab pegol
Subjects will receive dapriolizumab pegol throughout the Treatment Period.
Drug: Dapirolizumab pegol
Subjects will receive dapirolizumab pegol at prespecified time-points.
Other Names:
  • CDP7657
  • DZP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (TEAEs) during the study
Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of serious treatment-emergent adverse events during the study
Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalisation or prolongation of existing hospitalisation
  • Results in persistent disability/incapacity
  • Is a congenital anomaly or birth defect
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment.
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
Time Frame: Week 24
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Week 24
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
Time Frame: Week 52
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Week 52
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
Time Frame: Week 104
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Week 104
Achievement of LLDAS at ≥50% of all visits
Time Frame: From Baseline (Day 1) until End of Treatment (Week 104)

Low lupus disease activity state (LLDAS) is defined as:

  • No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever)
  • No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit
  • PGA ≤33 mm
  • Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day
  • Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol
From Baseline (Day 1) until End of Treatment (Week 104)
Achievement of BICLA response at Week 24
Time Frame: Week 24

A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled:

  1. British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and
  2. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
  3. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale

The parent studies Baseline will be used as reference point.
Week 24
Achievement of BICLA response at Week 52
Time Frame: Week 52

A study participant is considered to be a BICLA responder if all of the following is fulfilled:

  1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and
  2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
  3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale

The parent studies Baseline will be used as reference point.
Week 52
Achievement of BICLA response at Week 104
Time Frame: Week 104

A study participant is considered to be a BICLA responder if all of the following is fulfilled:

  1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and
  2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
  3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale

The parent studies Baseline will be used as reference point.
Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Estimated)

August 7, 2030

Study Completion (Estimated)

August 7, 2030

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL0046
  • 2019-003409-83 (EudraCT Number)
  • U1111-1293-7098 (Other Identifier: World Health Organization (WHO))
  • 2023-506368-14 (Registry Identifier: EU Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD Sharing Time Frame

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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