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New lupus drug tested for Long-Term safety in large trial

NCT ID NCT04976322

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study is checking the long-term safety of a drug called dapirolizumab pegol for people with systemic lupus erythematosus (lupus). It involves 760 participants who have already completed earlier studies of the drug. Researchers will monitor side effects over time to see if the drug is safe for extended use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapirolizumab pegol
What this could lead to
If successful, this could confirm that dapirolizumab pegol is safe enough for long-term use in lupus patients, potentially offering a new treatment option to control the disease.
What could go wrong
This is an extension study focused on safety, not on how well the drug works. It may still reveal unexpected side effects, and the drug may not be effective for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 760 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    119 sites in 23 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sl0046 20019

    Guangzhou, China

  • Sl0046 20020

    Shanghai, China

  • Sl0046 20025

    Wenzhou, China

  • Sl0046 20082

    Taiyuan, Taiwan

  • Sl0046 20095

    Taipei, Taiwan

  • Sl0046 20104

    Seoul, South Korea

  • Sl0046 20108

    Incheon, South Korea

  • Sl0046 20113

    Taichung, Taiwan

  • Sl0046 20128

    Beijing, China

  • Sl0046 20132

    Zhengzhou, China

  • Sl0046 20136

    Tianjin, China

  • Sl0046 20142

    Taichung, Taiwan

  • Sl0046 20180

    Wuhan, China

  • Sl0046 20181

    Makati, Philippines

  • Sl0046 20182

    Davao City, Philippines

  • Sl0046 20204

    Suzhou, China

  • Sl0046 20273

    Yangzhou, China

  • Sl0046 20290

    Guilin, China

  • Sl0046 20291

    Changchun, China

  • Sl0046 40027

    Herne, Germany

  • Sl0046 40031

    Szeged, Hungary

  • Sl0046 40044

    Poznan, Poland

  • Sl0046 40066

    Prague, Czechia

  • Sl0046 40072

    Freiburg im Breisgau, Germany

  • Sl0046 40078

    Leipzig, Germany

  • Sl0046 40084

    Catania, Italy

  • Sl0046 40090

    Poznan, Poland

  • Sl0046 40097

    Warsaw, Poland

  • Sl0046 40098

    Warsaw, Poland

  • Sl0046 40099

    Vigo, Spain

  • Sl0046 40101

    Sabadell, Spain

  • Sl0046 40119

    Bydgoszcz, Poland

  • Sl0046 40123

    Brussels, Belgium

  • Sl0046 40151

    Lublin, Poland

  • Sl0046 40160

    Barcelona, Spain

  • Sl0046 40189

    Plovdiv, Bulgaria

  • Sl0046 40341

    Málaga, Spain

  • Sl0046 40377

    Crete, Greece

  • Sl0046 40378

    Athens, Greece

  • Sl0046 40380

    Sofia, Bulgaria

  • Sl0046 40382

    Galati, Romania

  • Sl0046 40386

    Cologne, Germany

  • Sl0046 40393

    Belgrade, Serbia

  • Sl0046 40397

    Wroclaw, Poland

  • Sl0046 40398

    Katowice, Poland

  • Sl0046 40402

    Tübingen, Germany

  • Sl0046 40411

    Debrecen, Hungary

  • Sl0046 40412

    Budapest, Hungary

  • Sl0046 40448

    Milan, Italy

  • Sl0046 40461

    Belgrade, Serbia

  • Sl0046 40481

    Wroclaw, Poland

  • Sl0046 40482

    Bialystok, Poland

  • Sl0046 40499

    Székesfehérvár, Hungary

  • Sl0046 40501

    Athens, Greece

  • Sl0046 40502

    Krakow, Poland

  • Sl0046 40507

    Larissa, Greece

  • Sl0046 40715

    Vogelsang-gommern, Germany

  • Sl0046 50001

    Jackson, Tennessee, 38305, United States

  • Sl0046 50015

    Hagerstown, Maryland, 21740, United States

  • Sl0046 50045

    Toronto, Canada

  • Sl0046 50050

    Beckley, West Virginia, 25801, United States

  • Sl0046 50052

    Phoenix, Arizona, 85032, United States

  • Sl0046 50058

    Avondale, Arizona, 85392, United States

  • Sl0046 50059

    Ormond Beach, Florida, 32174, United States

  • Sl0046 50140

    Birmingham, Alabama, 35294, United States

  • Sl0046 50147

    Hershey, Pennsylvania, 17033, United States

  • Sl0046 50219

    Detroit, Michigan, 48201, United States

  • Sl0046 50238

    Charlotte, North Carolina, 28211, United States

  • Sl0046 50239

    Brandon, Florida, 33511, United States

  • Sl0046 50240

    Idaho Falls, Idaho, 83404, United States

  • Sl0046 50249

    Guadalajara, Mexico

  • Sl0046 50250

    Cuernavaca, Mexico

  • Sl0046 50251

    Monterrey, Mexico

  • Sl0046 50252

    Mérida, Mexico

  • Sl0046 50259

    Rimouski, Canada

  • Sl0046 50264

    Manhasset, New York, 11030, United States

  • Sl0046 50271

    León, Mexico

  • Sl0046 50273

    Las Vegas, Nevada, 89128, United States

  • Sl0046 50275

    La Palma, California, 90623-1730, United States

  • Sl0046 50285

    Lake Charles, Louisiana, 70605, United States

  • Sl0046 50316

    San Leandro, California, 94578, United States

  • Sl0046 50317

    Chihuahua City, Mexico

  • Sl0046 50324

    Plantation, Florida, 33324, United States

  • Sl0046 50328

    Tucson, Arizona, 85704, United States

  • Sl0046 50329

    Tampa, Florida, 33606, United States

  • Sl0046 50334

    New York, New York, 10032, United States

  • Sl0046 50337

    Edmonton AB, Canada

  • Sl0046 50339

    Denver, Colorado, 80230, United States

  • Sl0046 50362

    Gainesville, Florida, 32610, United States

  • Sl0046 50366

    Canton, New York, 13617, United States

  • Sl0046 50368

    Atlanta, Georgia, 30303, United States

  • Sl0046 50374

    Calgary, Canada

  • Sl0046 50383

    Beverly Hills, California, 90210, United States

  • Sl0046 50418

    Colleyville, Texas, 76034, United States

  • Sl0046 50474

    Hopkinsville, Kentucky, 42240-1746, United States

  • Sl0046 50660

    New Orleans, Louisiana, 70112, United States

  • Sl0046 50662

    Glendale, Arizona, 85306, United States

  • Sl0046 50671

    Caguas, Puerto Rico

  • Sl0046 50681

    Miami, Florida, 33172, United States

  • Sl0046 50698

    Tampa, Florida, 33618, United States

  • Sl0046 50699

    Chicago, Illinois, 60616, United States

  • Sl0046 50738

    Bellaire, Texas, 77401, United States

  • Sl0046 60002

    Buenos Aires, Argentina

  • Sl0046 60003

    Quilmes, Argentina

  • Sl0046 60006

    Bogotá, Colombia

  • Sl0046 60007

    Chía, Colombia

  • Sl0046 60009

    Lima, Peru

  • Sl0046 60011

    San Juan, Argentina

  • Sl0046 60013

    Barranquilla, Colombia

  • Sl0046 60014

    San Miguel de Tucumán, Argentina

  • Sl0046 60015

    Santiago, Chile

  • Sl0046 60016

    Bucaramanga, Colombia

  • Sl0046 60018

    Santiago, Chile

  • Sl0046 60019

    Barranquilla, Colombia

  • Sl0046 60022

    Quilmes, Argentina

  • Sl0046 60023

    Lima, Peru

  • Sl0046 60027

    Bogotá, Colombia

  • Sl0046 60029

    Mendoza, Argentina

  • Sl0046 60031

    Montería, Colombia

More trials for these conditions

Other studies related to the condition(s) this trial covers.