Recruiting

Phase 3

Dapirolizumab PegolA Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Sponsor:

UCB Biopharma SRL

Code:

NCT06617325

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

DZP

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT06617325

Start date

Nov 21, 2024

Status verified date

Sep, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:

a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 <lower limit of normal (LLN) OR complement C4 <LLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:
1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)
2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
3. Historical evidence for anti-dsDNA antibodies
4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:

British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND
SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:
Antimalarial treatment in combination with glucocorticoids and/or immunosuppressants or as stand-alone treatment if justified OR
Treatment with glucocorticoids and/or immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)

Exclusion Criteria:

Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric 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
Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy
Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \[eg, curettage, electrodesiccation\] not later than 4 weeks prior to the Screening Visit \[V1\]), basal cell carcinoma, or dermatological squamous cell carcinoma
Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
Study participant has clinically significant active or latent infection
Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection
Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol
Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP
Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dapirolizumab pegol

Study participants will receive dapriolizumab pegol throughout the Treatment Period.

placebo comparator: Placebo

Study participants will receive placebo throughout the Treatment Period.

Interventions

DZP

Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.

Placebo

Study participants will receive placebo at prespecified time-points.

Primary outcome measure

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48 [ Time Frame: Week 48 ]

Central Contacts and Locations

Central contacts

UCB Cares

1-844-599-2273 ucbcares@ucb.com

UCB Cares

001 844 599 2273

Locations

Sl0044 50058

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Avondale, Arizona, United States, 85392

Sl0044 50550

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Chandler, Arizona, United States, 85225

Sl0044 50713

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Gilbert, Arizona, United States, 85297

Sl0044 50662

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Glendale, Arizona, United States, 85306

Sl0044 50052

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Phoenix, Arizona, United States, 85032

Sl0044 50677

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Scottsdale, Arizona, United States, 85258

Sl0044 50670

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Searcy, Arkansas, United States, 72143

Sl0044 50737

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Beverly Hills, California, United States, 90210

Sl0044 50775

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Beverly Hills, California, United States, 90211

Sl0044 50257

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La Jolla, California, United States, 92037

Sl0044 50275

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La Palma, California, United States, 90623-1730

Sl0044 50755

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Los Alamitos, California, United States, 90720

Sl0044 50258

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Los Angeles, California, United States, 90022

Sl0044 50725

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Menifee, California, United States, 92586

Sl0044 50340

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Orange, California, United States, 92868

Sl0044 50316

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San Leandro, California, United States, 94578

Sl0044 50719

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Aurora, Colorado, United States, 80045

Sl0044 50239

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Brandon, Florida, United States, 33511

Sl0044 50630

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Clearwater, Florida, United States, 33765

Sl0044 50751

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Coral Gables, Florida, United States, 33134

Sl0044 50362

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Gainesville, Florida, United States, 32610

Sl0044 50766

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Hollywood, Florida, United States, 33024

Sl0044 50763

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Margate, Florida, United States, 33063

Sl0044 50747

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Miami, Florida, United States, 33126

Sl0044 50735

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Miami, Florida, United States, 33155

Sl0044 50681

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Miami, Florida, United States, 33172

Sl0044 50324

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Plantation, Florida, United States, 33324

Sl0044 50698

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Tampa, Florida, United States, 33618

Sl0044 50585

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Winter Park, Florida, United States, 32789

Sl0044 50566

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Gainesville, Georgia, United States, 30501-2418

Sl0044 50659

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Marietta, Georgia, United States, 30152

Sl0044 50699

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Chicago, Illinois, United States, 60616

Sl0044 50717

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Willowbrook, Illinois, United States, 60527

Sl0044 50748

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New Albany, Indiana, United States, 47150

Sl0044 50319

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Iowa City, Iowa, United States, 52242.

Sl0044 50074

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Kansas City, Kansas, United States, 66160

Sl0044 50586

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Louisville, Kentucky, United States, 40202-5700

Sl0044 50023

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Baton Rouge, Louisiana, United States, 70836

Sl0044 50285

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Lake Charles, Louisiana, United States, 70605

Sl0044 50660

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New Orleans, Louisiana, United States, 70112

Sl0044 50730

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Rockville, Maryland, United States, 20850

Sl0044 50219

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Detroit, Michigan, United States, 48201

Sl0044 50682

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Kansas City, Missouri, United States, 64151

Sl0044 50010

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Brooklyn, New York, United States, 11201

Sl0044 50264

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Manhasset, New York, United States, 11030

Sl0044 50077

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New York, New York, United States, 10021

Sl0044 50241

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Syracuse, New York, United States, 13210

Sl0044 50238

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Charlotte, North Carolina, United States, 28211

Sl0044 50365

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Pittsburgh, Pennsylvania, United States, 15213

Sl0044 50001

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Jackson, Tennessee, United States, 38305

Sl0044 50693

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Murfreesboro, Tennessee, United States, 37128

Sl0044 50738

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Bellaire, Texas, United States, 77401

Sl0044 50781

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El Paso, Texas, United States, 79902

Sl0044 50673

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Fort Worth, Texas, United States, 76109

Sl0044 50562

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Frisco, Texas, United States, 75035

Sl0044 50773

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Grapevine, Texas, United States, 76051

Sl0044 50688

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Houston, Texas, United States, 77054

Sl0044 50696

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Houston, Texas, United States, 77090

Sl0044 50723

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Houston, Texas, United States, 77090

Sl0044 50718

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Mansfield, Texas, United States, 76063

Sl0044 50036

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Mesquite, Texas, United States, 75150

Sl0044 50061

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Spokane Valley, Washington, United States, 99216

Sl0044 50771

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Québec, Canada

Sl0044 50259

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Rimouski, Canada

Sl0044 50045

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Toronto, Canada

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

Systemic lupus erythematosus
Dapirolizumab pegol
SLE
DZP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-09-04.