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

NCT ID: NCT04976322

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2030-08-07

Brief Summary

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

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Keywords

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Systemic lupus erythematosus Dapirolizumab pegol SLE DZP

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dapirolizumab pegol

Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Group Type EXPERIMENTAL

Dapirolizumab pegol

Intervention Type DRUG

Subjects will receive dapirolizumab pegol at prespecified time-points.

Interventions

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Dapirolizumab pegol

Subjects will receive dapirolizumab pegol at prespecified time-points.

Intervention Type DRUG

Other Intervention Names

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DZP CDP7657

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

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Sl0046 50140

Birmingham, Alabama, United States

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Sl0046 50328

Tucson, Arizona, United States

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Sl0046 50383

Beverly Hills, California, United States

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La Palma, California, United States

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San Leandro, California, United States

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Denver, Colorado, United States

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Brandon, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Ormond Beach, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Idaho Falls, Idaho, United States

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Hopkinsville, Kentucky, United States

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Lake Charles, Louisiana, United States

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Sl0046 50015

Hagerstown, Maryland, United States

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Detroit, Michigan, United States

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Las Vegas, Nevada, United States

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Canton, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Hershey, Pennsylvania, United States

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Jackson, Tennessee, United States

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Colleyville, Texas, United States

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Sl0046 50050

Beckley, West Virginia, United States

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Sl0046 60002

Buenos Aires, , Argentina

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Sl0046 60029

Mendoza, , Argentina

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Sl0046 60003

Quilmes, , Argentina

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Quilmes, , Argentina

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Sl0046 60011

San Juan, , Argentina

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Sl0046 60014

San Miguel de Tucumán, , Argentina

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Sl0046 40123

Brussels, , Belgium

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Sl0046 40189

Plovdiv, , Bulgaria

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Sl0046 40380

Sofia, , Bulgaria

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Sl0046 50374

Calgary, , Canada

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Edmonton AB, , Canada

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Sl0046 50259

Rimouski, , Canada

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Toronto, , Canada

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Sl0046 60015

Santiago, , Chile

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Santiago, , Chile

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Sl0046 60013

Barranquilla, , Colombia

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Sl0046 60019

Barranquilla, , Colombia

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Sl0046 60006

Bogotá, , Colombia

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Sl0046 60027

Bogotá, , Colombia

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Sl0046 60016

Bucaramanga, , Colombia

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Chía, , Colombia

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Montería, , Colombia

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Prague, , Czechia

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Sl0046 40386

Cologne, , Germany

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Sl0046 40072

Freiburg im Breisgau, , Germany

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Herne, , Germany

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Leipzig, , Germany

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Tübingen, , Germany

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Athens, , Greece

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Sl0046 40501

Athens, , Greece

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Crete, , Greece

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Larissa, , Greece

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Sl0046 40412

Budapest, , Hungary

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Sl0046 40411

Debrecen, , Hungary

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Sl0046 40031

Szeged, , Hungary

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Sl0046 40499

Székesfehérvár, , Hungary

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Sl0046 40084

Catania, , Italy

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Milan, , Italy

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Chihuahua City, , Mexico

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Cuernavaca, , Mexico

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Guadalajara, , Mexico

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León, , Mexico

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Mérida, , Mexico

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Monterrey, , Mexico

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Sl0046 60009

Lima, , Peru

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Lima, , Peru

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Sl0046 20182

Davao City, , Philippines

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Makati, , Philippines

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Sl0046 40482

Bialystok, , Poland

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Sl0046 40119

Bydgoszcz, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Sl0046 40098

Warsaw, , Poland

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Sl0046 40397

Wroclaw, , Poland

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Sl0046 40481

Wroclaw, , Poland

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Galati, , Romania

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Sl0046 40393

Belgrade, , Serbia

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Sl0046 40461

Belgrade, , Serbia

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Sl0046 20108

Incheon, , South Korea

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Sl0046 20104

Seoul, , South Korea

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Sl0046 40160

Barcelona, , Spain

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Sl0046 40341

Málaga, , Spain

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Sl0046 40101

Sabadell, , Spain

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Sl0046 40099

Vigo, , Spain

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Sl0046 20113

Taichung, , Taiwan

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Sl0046 20142

Taichung, , Taiwan

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Sl0046 20095

Taipei, , Taiwan

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Sl0046 20082

Taiyuan, , Taiwan

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Countries

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United States Argentina Belgium Bulgaria Canada Chile Colombia Czechia Germany Greece Hungary Italy Mexico Peru Philippines Poland Romania Serbia South Korea Spain Taiwan

Other Identifiers

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2019-003409-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1293-7098

Identifier Type: OTHER

Identifier Source: secondary_id

2023-506368-14

Identifier Type: REGISTRY

Identifier Source: secondary_id

SL0046

Identifier Type: -

Identifier Source: org_study_id