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Systemic Lupus ErythematosusPhase 3NCT04976322

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

A Phase 3 study testing Dapirolizumab pegol in people with Systemic Lupus Erythematosus, run by UCB Biopharma SRL at 123 sites in 24 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 16 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Dapirolizumab pegol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
760 participants
Where
123 sitesin 24 countries
Study dates
27 Jul 2021to 7 Aug 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

123 sites in 24 countries. Contact the study team or a site near you to ask about taking part.

123 sites in 24 countries

United States34 sites

  • Sl0046 50368

    Atlanta, Georgia, 30303

  • Sl0046 50058

    Avondale, Arizona, 85392

  • Sl0046 50050

    Beckley, West Virginia, 25801

  • Sl0046 50738

    Bellaire, Texas, 77401

  • Sl0046 50383

    Beverly Hills, California, 90210

  • Sl0046 50140

    Birmingham, Alabama, 35294

  • Sl0046 50239

    Brandon, Florida, 33511

  • Sl0046 50366

    Canton, New York, 13617

  • Sl0046 50238

    Charlotte, North Carolina, 28211

  • Sl0046 50699

    Chicago, Illinois, 60616

  • Sl0046 50418

    Colleyville, Texas, 76034

  • Sl0046 50339

    Denver, Colorado, 80230

  • Sl0046 50219

    Detroit, Michigan, 48201

  • Sl0046 50362

    Gainesville, Florida, 32610

  • Sl0046 50662

    Glendale, Arizona, 85306

  • Sl0046 50015

    Hagerstown, Maryland, 21740

  • Sl0046 50147

    Hershey, Pennsylvania, 17033

  • Sl0046 50474

    Hopkinsville, Kentucky, 42240-1746

  • Sl0046 50240

    Idaho Falls, Idaho, 83404

  • Sl0046 50001

    Jackson, Tennessee, 38305

  • Sl0046 50275

    La Palma, California, 90623-1730

  • Sl0046 50285

    Lake Charles, Louisiana, 70605

  • Sl0046 50273

    Las Vegas, Nevada, 89128

  • Sl0046 50264

    Manhasset, New York, 11030

  • Sl0046 50681

    Miami, Florida, 33172

  • Sl0046 50660

    New Orleans, Louisiana, 70112

  • Sl0046 50334

    New York, New York, 10032

  • Sl0046 50059

    Ormond Beach, Florida, 32174

  • Sl0046 50052

    Phoenix, Arizona, 85032

  • Sl0046 50324

    Plantation, Florida, 33324

  • Sl0046 50316

    San Leandro, California, 94578

  • Sl0046 50329

    Tampa, Florida, 33606

  • Sl0046 50698

    Tampa, Florida, 33618

  • Sl0046 50328

    Tucson, Arizona, 85704

Other trials in United States

China12 sites

  • Sl0046 20128

    Beijing

  • Sl0046 20291

    Changchun

  • Sl0046 20019

    Guangzhou

  • Sl0046 20290

    Guilin

  • Sl0046 20020

    Shanghai

  • Sl0046 20346

    Shantou

  • Sl0046 20204

    Suzhou

  • Sl0046 20136

    Tianjin

  • Sl0046 20025

    Wenzhou

  • Sl0046 20180

    Wuhan

  • Sl0046 20273

    Yangzhou

  • Sl0046 20132

    Zhengzhou

Other trials in China

Poland11 sites

  • Sl0046 40482

    Bialystok

  • Sl0046 40119

    Bydgoszcz

  • Sl0046 40398

    Katowice

  • Sl0046 40502

    Krakow

  • Sl0046 40151

    Lublin

  • Sl0046 40044

    Poznan

  • Sl0046 40090

    Poznan

  • Sl0046 40097

    Warsaw

  • Sl0046 40098

    Warsaw

  • Sl0046 40397

    Wroclaw

  • Sl0046 40481

    Wroclaw

Other trials in Poland

Colombia7 sites

  • Sl0046 60013

    Barranquilla

  • Sl0046 60019

    Barranquilla

  • Sl0046 60006

    Bogotá

  • Sl0046 60027

    Bogotá

  • Sl0046 60016

    Bucaramanga

  • Sl0046 60007

    Chía

  • Sl0046 60031

    Montería

Other trials in Colombia

Argentina6 sites

  • Sl0046 60002

    Buenos Aires

  • Sl0046 60029

    Mendoza

  • Sl0046 60003

    Quilmes

  • Sl0046 60022

    Quilmes

  • Sl0046 60011

    San Juan

  • Sl0046 60014

    San Miguel de Tucumán

Other trials in Argentina

Germany6 sites

  • Sl0046 40386

    Cologne

  • Sl0046 40072

    Freiburg im Breisgau

  • Sl0046 40027

    Herne

  • Sl0046 40078

    Leipzig

  • Sl0046 40402

    Tübingen

  • Sl0046 40715

    Vogelsang-gommern

Other trials in Germany

Mexico6 sites

  • Sl0046 50317

    Chihuahua City

  • Sl0046 50250

    Cuernavaca

  • Sl0046 50249

    Guadalajara

  • Sl0046 50271

    León

  • Sl0046 50252

    Mérida

  • Sl0046 50251

    Monterrey

Other trials in Mexico

Canada4 sites

  • Sl0046 50374

    Calgary

  • Sl0046 50337

    Edmonton AB

  • Sl0046 50259

    Rimouski

  • Sl0046 50045

    Toronto

Other trials in Canada

Greece4 sites

  • Sl0046 40378

    Athens

  • Sl0046 40501

    Athens

  • Sl0046 40377

    Crete

  • Sl0046 40507

    Larissa

Other trials in Greece

Hungary4 sites

  • Sl0046 40412

    Budapest

  • Sl0046 40411

    Debrecen

  • Sl0046 40031

    Szeged

  • Sl0046 40499

    Székesfehérvár

Other trials in Hungary

Serbia4 sites

  • Sl0046 40393

    Belgrade

  • Sl0046 40461

    Belgrade

  • Sl0046 40730

    Belgrade

  • Sl0046 40392

    Novi Sad

Other trials in Serbia

Spain4 sites

  • Sl0046 40160

    Barcelona

  • Sl0046 40341

    Málaga

  • Sl0046 40101

    Sabadell

  • Sl0046 40099

    Vigo

Other trials in Spain

Taiwan4 sites

  • Sl0046 20113

    Taichung

  • Sl0046 20142

    Taichung

  • Sl0046 20095

    Taipei

  • Sl0046 20082

    Taiyuan

Other trials in Taiwan

Bulgaria2 sites

  • Sl0046 40189

    Plovdiv

  • Sl0046 40380

    Sofia

Other trials in Bulgaria

Chile2 sites

  • Sl0046 60015

    Santiago

  • Sl0046 60018

    Santiago

Other trials in Chile

Italy2 sites

  • Sl0046 40084

    Catania

  • Sl0046 40448

    Milan

Other trials in Italy

Peru2 sites

  • Sl0046 60009

    Lima

  • Sl0046 60023

    Lima

Other trials in Peru

Philippines2 sites

  • Sl0046 20182

    Davao City

  • Sl0046 20181

    Makati

Other trials in Philippines

South Korea2 sites

  • Sl0046 20108

    Incheon

  • Sl0046 20104

    Seoul

Other trials in South Korea

Belgium1 site

  • Sl0046 40123

    Brussels

Other trials in Belgium

Czechia1 site

  • Sl0046 40066

    Prague

Other trials in Czechia

Japan1 site

  • Sl0046 20287

    Nagoya

Other trials in Japan

Puerto Rico1 site

  • Sl0046 50671

    Caguas

Other trials in Puerto Rico

Romania1 site

  • Sl0046 40382

    Galati

Other trials in Romania

About this study

Official title: 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.

Being tested
Dapirolizumab pegol
Keywords
Systemic lupus erythematosus, Dapirolizumab pegol, SLE, DZP
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapirolizumab pegolDrug

    Also called DZP, CDP7657

    Subjects will receive dapirolizumab pegol at prespecified time-points.

Study groups in NCT04976322
Study groupRoleWhat they receive
Dapirolizumab pegolExperimentalSubjects will receive dapriolizumab pegol throughout the Treatment Period.
Receives: Drug: Dapirolizumab pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs) during the study

    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.

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

  2. Incidence of serious treatment-emergent adverse events during the study

    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

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

  3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation

    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.

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

Secondary outcomes (7)

  1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through 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).

    Measured: Week 24

  2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through 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).

    Measured: Week 52

  3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through 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).

    Measured: Week 104

  4. Achievement of LLDAS at ≥50% of all visits

    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

    Measured: From Baseline (Day 1) until End of Treatment (Week 104)

  5. Achievement of BICLA response at 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.

    Measured: Week 24

  6. Achievement of BICLA response at 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.

    Measured: Week 52

  7. Achievement of BICLA response at 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.

    Measured: Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2021
  2. Study start27 Jul 2021
  3. Primary completion7 Aug 2030 (estimated)
  4. Study completion7 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
760 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04976322
Sponsor's protocol ID
SL0046
Other IDs
2019-003409-83, U1111-1293-7098, 2023-506368-14, 2023, 2019
Status last verified
Oct 2026
First submitted
14 Jul 2021
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapirolizumab pegol in people with Systemic Lupus Erythematosus, run by UCB Biopharma SRL at 123 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, China, Poland, Colombia, Argentina and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) during the study (time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04976322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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