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

Last updated: June 25, 2026
Sponsor: UCB Biopharma SRL
Overall Status: Active - Enrolling

Phase

3

Condition

Cutaneous Lupus Erythematosus

Musculoskeletal Diseases

Systemic Lupus Erythematosus

Treatment

Dapirolizumab pegol

Clinical Study ID

NCT04976322
SL0046
2023-506368-14
2019-003409-83
U1111-1293-7098
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant could, in the opinion of the Investigator, benefit from long-termdapirolizumab pegol (DZP) treatment

  • The participant completed one of the parent studies within 4 weeks prior to entry tothis study

Exclusion

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 Design

Total Participants: 760
Treatment Group(s): 1
Primary Treatment: Dapirolizumab pegol
Phase: 3
Study Start date:
July 27, 2021
Estimated Completion Date:
August 07, 2030

Connect with a study center

  • Sl0046 60002

    Buenos Aires,
    Argentina

    Site Not Available

  • Sl0046 60029

    Mendoza,
    Argentina

    Site Not Available

  • Sl0046 60003

    Quilmes,
    Argentina

    Site Not Available

  • Sl0046 60022

    Quilmes,
    Argentina

    Site Not Available

  • Sl0046 60022

    Quilmes 3429652,
    Argentina

    Site Not Available

  • Sl0046 60011

    San Juan,
    Argentina

    Site Not Available

  • Sl0046 60014

    San Miguel de Tucumán,
    Argentina

    Site Not Available

  • Sl0046 60014

    Tucuman,
    Argentina

    Site Not Available

  • Sl0046 40123

    Brussels,
    Belgium

    Site Not Available

  • Sl0046 40123

    Bruxelles,
    Belgium

    Site Not Available

  • Sl0046 40006

    Plovdiv,
    Bulgaria

    Site Not Available

  • Sl0046 40189

    Plovdiv,
    Bulgaria

    Site Not Available

  • Sl0046 40380

    Sofia,
    Bulgaria

    Site Not Available

  • Sl0046 50374

    Calgary,
    Canada

    Site Not Available

  • Sl0046 50337

    Edmonton AB,
    Canada

    Site Not Available

  • Sl0046 50259

    Rimouski,
    Canada

    Site Not Available

  • Sl0046 50045

    Toronto,
    Canada

    Site Not Available

  • Sl0046 50044

    Trois-rivieres,
    Canada

    Site Not Available

  • Sl0046 60015

    Santiago,
    Chile

    Site Not Available

  • Sl0046 60018

    Santiago,
    Chile

    Site Not Available

  • Sl0046 60015

    Santiago 3871336,
    Chile

    Site Not Available

  • Sl0046 60015

    Santiago de Chile,
    Chile

    Site Not Available

  • Sl0046 20291

    Changchun,
    China

    Site Not Available

  • Sl0046 20019

    Guangzhou,
    China

    Site Not Available

  • Sl0046 20290

    Guilin,
    China

    Site Not Available

  • Sl0046 20020

    Shanghai,
    China

    Site Not Available

  • Sl0046 20136

    Tianjin,
    China

    Site Not Available

  • Sl0046 20025

    Wenzhou,
    China

    Site Not Available

  • Sl0046 20180

    Wuhan,
    China

    Site Not Available

  • Sl0046 20132

    Zhengzhou,
    China

    Site Not Available

  • Sl0046 60013

    Barranquilla,
    Colombia

    Site Not Available

  • Sl0046 60019

    Barranquilla,
    Colombia

    Site Not Available

  • Sl0046 60019

    Barranquilla 3689147,
    Colombia

    Site Not Available

  • Sl0046 60006

    Bogota,
    Colombia

    Site Not Available

  • Sl0046 60006

    Bogotá,
    Colombia

    Site Not Available

  • Sl0046 60027

    Bogotá,
    Colombia

    Site Not Available

  • Sl0046 60027

    Bogotá 3688689,
    Colombia

    Site Not Available

  • Sl0046 60016

    Bucaramanga,
    Colombia

    Site Not Available

  • Sl0046 60007

    Chía,
    Colombia

    Site Not Available

  • Sl0046 60031

    Montería,
    Colombia

    Site Not Available

  • Sl0046 40066

    Prague,
    Czechia

    Site Not Available

  • Sl0046 40066

    Praha 2,
    Czechia

    Site Not Available

  • Sl0046 40386

    Cologne,
    Germany

    Site Not Available

  • Sl0046 40072

    Freiburg im Breisgau,
    Germany

    Site Not Available

  • Sl0046 40027

    Herne,
    Germany

    Site Not Available

  • Sl0046 40078

    Leipzig,
    Germany

    Site Not Available

  • Sl0046 40402

    Tübingen,
    Germany

    Site Not Available

  • Sl0046 40715

    Vogelsang-gommern,
    Germany

    Site Not Available

  • Sl0046 40378

    Athens,
    Greece

    Site Not Available

  • Sl0046 40501

    Athens,
    Greece

    Site Not Available

  • Sl0046 40378

    Athens 264371,
    Greece

    Site Not Available

  • Sl0046 40377

    Crete,
    Greece

    Site Not Available

  • Sl0046 40507

    Larissa,
    Greece

    Site Not Available

  • Sl0046 40412

    Budapest,
    Hungary

    Site Not Available

  • Sl0046 40411

    Debrecen,
    Hungary

    Site Not Available

  • Sl0046 40031

    Szeged,
    Hungary

    Site Not Available

  • Sl0046 40499

    Szekesfehervar,
    Hungary

    Site Not Available

  • Sl0046 40499

    Székesfehérvár,
    Hungary

    Site Not Available

  • Sl0046 40084

    Catania,
    Italy

    Site Not Available

  • Sl0046 40448

    Milan,
    Italy

    Site Not Available

  • Sl0046 20030

    Chūōku,
    Japan

    Site Not Available

  • Sl0046 20287

    Nagoya,
    Japan

    Site Not Available

  • Sl0046 20031

    Sapporo,
    Japan

    Site Not Available

  • Sl0046 20171

    Sendai,
    Japan

    Site Not Available

  • Sl0046 50317

    Chihuahua City,
    Mexico

    Site Not Available

  • Sl0046 50250

    Cuernavaca,
    Mexico

    Site Not Available

  • Sl0046 50249

    Guadalajara,
    Mexico

    Site Not Available

  • Sl0046 50271

    Leon,
    Mexico

    Site Not Available

  • Sl0046 50271

    León,
    Mexico

    Site Not Available

  • Sl0046 50252

    Merida,
    Mexico

    Site Not Available

  • Sl0046 50251

    Monterrey,
    Mexico

    Site Not Available

  • Sl0046 50252

    Mérida,
    Mexico

    Site Not Available

  • Sl0046 60009

    Lima,
    Peru

    Site Not Available

  • Sl0046 60023

    Lima,
    Peru

    Site Not Available

  • Sl0046 60009

    Lima 3936456,
    Peru

    Site Not Available

  • Sl0046 20182

    Davao City,
    Philippines

    Site Not Available

  • Sl0046 20181

    Makati,
    Philippines

    Site Not Available

  • Sl0046 40482

    Bialystok,
    Poland

    Site Not Available

  • Sl0046 40119

    Bydgoszcz,
    Poland

    Site Not Available

  • Sl0046 40398

    Katowice,
    Poland

    Site Not Available

  • Sl0046 40502

    Krakow,
    Poland

    Site Not Available

  • Sl0046 40151

    Lublin,
    Poland

    Site Not Available

  • Sl0046 40044

    Poznan,
    Poland

    Site Not Available

  • Sl0046 40090

    Poznan,
    Poland

    Site Not Available

  • Sl0046 40090

    Poznan 3088171,
    Poland

    Site Not Available

  • Sl0046 40097

    Warsaw,
    Poland

    Site Not Available

  • Sl0046 40098

    Warsaw,
    Poland

    Site Not Available

  • Sl0046 40098

    Warsaw 756135,
    Poland

    Site Not Available

  • Sl0046 40097

    Warszawa,
    Poland

    Site Not Available

  • Sl0046 40098

    Warszawa,
    Poland

    Site Not Available

  • Sl0046 40397

    Wroclaw,
    Poland

    Site Not Available

  • Sl0046 40481

    Wroclaw,
    Poland

    Site Not Available

  • Sl0046 40481

    Wroclaw 3081368,
    Poland

    Site Not Available

  • Sl0046 50671

    Caguas,
    Puerto Rico

    Site Not Available

  • Sl0046 40382

    Galati,
    Romania

    Site Not Available

  • Sl0046 40393

    Belgrade,
    Serbia

    Site Not Available

  • Sl0046 40461

    Belgrade,
    Serbia

    Site Not Available

  • Sl0046 40461

    Belgrade 792680,
    Serbia

    Site Not Available

  • Sl0046 20108

    Incheon,
    South Korea

    Site Not Available

  • Sl0046 20104

    Seoul,
    South Korea

    Site Not Available

  • Sl0046 40160

    Barcelona,
    Spain

    Site Not Available

  • Sl0046 40341

    Málaga,
    Spain

    Site Not Available

  • Sl0046 40101

    Sabadell,
    Spain

    Site Not Available

  • Sl0046 40099

    Vigo,
    Spain

    Site Not Available

  • Sl0046 20082

    Kuei-san Hsiang,
    Taiwan

    Site Not Available

  • Sl0046 20113

    Taichung,
    Taiwan

    Site Not Available

  • Sl0046 20142

    Taichung,
    Taiwan

    Site Not Available

  • Sl0046 20142

    Taichung 1668399,
    Taiwan

    Site Not Available

  • Sl0046 20142

    Taichung City,
    Taiwan

    Site Not Available

  • Sl0046 20095

    Taipei,
    Taiwan

    Site Not Available

  • Sl0046 20082

    Taiyuan,
    Taiwan

    Site Not Available

  • Sl0046 50140

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Sl0046 50058

    Avondale, Arizona 85392
    United States

    Site Not Available

  • Sl0046 50328

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Sl0046 50383

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Sl0046 50275

    La Palma, California 90623-1730
    United States

    Site Not Available

  • Sl0046 50316

    San Leandro, California 94578
    United States

    Site Not Available

  • Sl0046 50383

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Sl0046 50339

    Denver, Colorado 80230
    United States

    Site Not Available

  • Sl0046 50239

    Brandon, Florida 33511
    United States

    Site Not Available

  • Sl0046 50362

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Sl0046 50681

    Miami, Florida 33172
    United States

    Site Not Available

  • Sl0046 50059

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Sl0046 50324

    Plantation, Florida 33324
    United States

    Site Not Available

  • Sl0046 50329

    Tampa, Florida 33606
    United States

    Site Not Available

  • Sl0046 50698

    Tampa, Florida 33618
    United States

    Site Not Available

  • Sl0046 50368

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Sl0046 50240

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Sl0046 50474

    Hopkinsville, Kentucky 42240-1746
    United States

    Site Not Available

  • Sl0046 50285

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Sl0046 50015

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Sl0046 50219

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Sl0046 50273

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Sl0046 50366

    Canton, New York 13617
    United States

    Site Not Available

  • Sl0046 50264

    Manhasset, New York 11030
    United States

    Site Not Available

  • Sl0046 50334

    New York, New York 10032
    United States

    Site Not Available

  • Sl0046 50238

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Sl0046 50147

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Sl0046 50001

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Sl0046 50418

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Sl0046 50050

    Beckley, West Virginia 25801
    United States

    Site Not Available

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