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RECRUITING

NCT06617325

PHASE3

A 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

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-11-21

Completion Date

2028-05-31

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus

Interventions

DRUG

DZP

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

OTHER

Placebo

Study participants will receive placebo at prespecified time-points.

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

Locations (219)

Sl0044 50058

Avondale, Arizona, United States

Sl0044 50550

Chandler, Arizona, United States

Sl0044 50713

Gilbert, Arizona, United States

Sl0044 50662

Glendale, Arizona, United States

Sl0044 50052

Phoenix, Arizona, United States

Sl0044 50670

Searcy, Arkansas, United States

Sl0044 50737

Beverly Hills, California, United States

Sl0044 50257

La Jolla, California, United States

Sl0044 50275

La Palma, California, United States

Sl0044 50755

Los Alamitos, California, United States

Sl0044 50258

Los Angeles, California, United States

Sl0044 50725

Menifee, California, United States

Sl0044 50340

Orange, California, United States

Sl0044 50316

San Leandro, California, United States

Sl0044 50719

Aurora, Colorado, United States

Sl0044 50239

Brandon, Florida, United States

Sl0044 50630

Clearwater, Florida, United States

Sl0044 50747

Coral Gables, Florida, United States

Sl0044 50751

Coral Gables, Florida, United States

Sl0044 50362

Gainesville, Florida, United States

Sl0044 50763

Margate, Florida, United States

Sl0044 50735

Miami, Florida, United States

Sl0044 50681

Miami, Florida, United States

Sl0044 50324

Plantation, Florida, United States

Sl0044 50698

Tampa, Florida, United States

Sl0044 50585

Winter Park, Florida, United States

Sl0044 50566

Gainesville, Georgia, United States

Sl0044 50659

Marietta, Georgia, United States

Sl0044 50699

Chicago, Illinois, United States

Sl0044 50717

Willowbrook, Illinois, United States

Sl0044 50748

New Albany, Indiana, United States

Sl0044 50074

Kansas City, Kansas, United States

Sl0044 50586

Louisville, Kentucky, United States

Sl0044 50023

Baton Rouge, Louisiana, United States

Sl0044 50285

Lake Charles, Louisiana, United States

Sl0044 50660

New Orleans, Louisiana, United States

Sl0044 50730

Rockville, Maryland, United States

Sl0044 50219

Detroit, Michigan, United States

Sl0044 50682

Kansas City, Missouri, United States

Sl0044 50010

Brooklyn, New York, United States

Sl0044 50264

Manhasset, New York, United States

Sl0044 50077

New York, New York, United States

Sl0044 50241

Syracuse, New York, United States

Sl0044 50238

Charlotte, North Carolina, United States

Sl0044 50365

Pittsburgh, Pennsylvania, United States

Sl0044 50001

Jackson, Tennessee, United States

Sl0044 50693

Murfreesboro, Tennessee, United States

Sl0044 50562

Allen, Texas, United States

Sl0044 50738

Bellaire, Texas, United States

Sl0044 50673

Fort Worth, Texas, United States

Sl0044 50723

Houston, Texas, United States

Sl0044 50688

Houston, Texas, United States

Sl0044 50696

Houston, Texas, United States

Sl0044 50773

Irving, Texas, United States

Sl0044 50718

Mansfield, Texas, United States

Sl0044 50036

Mesquite, Texas, United States

Sl0044 50061

Spokane Valley, Washington, United States

Sl0044 60004

C.a.b.a, Argentina

Sl0044 60002

Capital Federal, Argentina

Sl0044 60024

Córdoba, Argentina

Sl0044 60029

Mendoza, Argentina

Sl0044 60003

Quilmes, Argentina

Sl0044 60011

San Juan, Argentina

Sl0044 60014

San Miguel de Tucumán, Argentina

Sl0044 40002

Leuven, Belgium

Sl0044 40060

Liège, Belgium

Sl0044 50259

Rimouski, Canada

Sl0044 50045

Toronto, Canada

Sl0044 60018

Santiago, Chile

Sl0044 20293

Baotou, China

Sl0044 20128

Beijing, China

Sl0044 20157

Beijing, China

Sl0044 20173

Beijing, China

Sl0044 20201

Bengbu, China

Sl0044 20291

Changchun, China

Sl0044 20342

Changchun, China

Sl0044 20295

Changsha, China

Sl0044 20186

Changzhou, China

Sl0044 20137

Chengdu, China

Sl0044 20019

Guangzhou, China

Sl0044 20360

Guangzhou, China

Sl0044 20290

Guilin, China

Sl0044 20271

Haikou, China

Sl0044 20296

Hangzhou, China

Sl0044 20185

Jinan, China

Sl0044 20364

Jiujiang, China

Sl0044 20192

Nanchang, China

Sl0044 20024

Nanjing, China

Sl0044 20331

Nanning, China

Sl0044 20272

Pingxiang, China

Sl0044 20020

Shanghai, China

Sl0044 20172

Shanghai, China

Sl0044 20346

Shantou, China

Sl0044 20363

Shijiazhuang, China

Sl0044 20204

Suzhou, China

Sl0044 20136

Tianjin, China

Sl0044 20275

Urumuqi, China

Sl0044 20025

Wenzhou, China

Sl0044 20180

Wuhan, China

Sl0044 20270

Wuhan, China

Sl0044 20274

Xi'an, China

Sl0044 20341

Xiamen, China

Sl0044 20273

Yangzhou, China

Sl0044 20132

Zhengzhou, China

Sl0044 20361

Zhuzhou, China

Sl0044 40903

Aalborg, Denmark

Sl0044 40513

Copenhagen, Denmark

Sl0044 40489

Odense, Denmark

Sl0044 40848

Le Mans, France

Sl0044 40506

Montpellier, France

Sl0044 40480

Berlin, Germany

Sl0044 40386

Cologne, Germany

Sl0044 40716

Cologne, Germany

Sl0044 40322

Dessau, Germany

Sl0044 40356

Dresden, Germany

Sl0044 40072

Freiburg im Breisgau, Germany

Sl0044 40717

Greifswald, Germany

Sl0044 40027

Herne, Germany

Sl0044 40139

Jena, Germany

Sl0044 40078

Leipzig, Germany

Sl0044 40854

Mainz, Germany

Sl0044 40815

München, Germany

Sl0044 40402

Tübingen, Germany

Sl0044 40715

Vogelsang-gommern, Germany

Sl0044 40376

Athens, Greece

Sl0044 40501

Athens, Greece

Sl0044 40377

Heraklion, Greece

Sl0044 40507

Larissa, Greece

Sl0044 40816

Brescia, Italy

Sl0044 40514

Genova, Italy

Sl0044 40291

Milan, Italy

Sl0044 40471

Milan, Italy

Sl0044 40509

Padova, Italy

Sl0044 40176

Pisa, Italy

Sl0044 40148

Roma, Italy

Sl0044 40675

Roma, Italy

Sl0044 40860

Roma, Italy

Sl0044 40830

Rozzano, Italy

Sl0044 20035

Bunkyō City, Japan

Sl0044 20196

Bunkyō City, Japan

Sl0044 20279

Bunkyō City, Japan

Sl0044 20030

Chūōku, Japan

Sl0044 20281

Fukuoka, Japan

Sl0044 20039

Kawagoe, Japan

Sl0044 20045

Kita-gun, Japan

Sl0044 20065

Kitakyushu, Japan

Sl0044 20301

Kurashiki, Japan

Sl0044 20069

Meguro-ku, Japan

Sl0044 20071

Nagasaki, Japan

Sl0044 20287

Nagoya, Japan

Sl0044 20084

Saga, Japan

Sl0044 20283

Sagamihara, Japan

Sl0044 20031

Sapporo, Japan

Sl0044 20042

Sasebo, Japan

Sl0044 20171

Sendai, Japan

Sl0044 20070

Shinjuku-ku, Japan

Sl0044 20076

Shinjuku-ku, Japan

Sl0044 20285

Shinjuku-ku, Japan

Sl0044 20288

Shinjuku-ku, Japan

Sl0044 20277

Suita, Japan

Sl0044 20032

Suita-shi, Japan

Sl0044 20278

Tsu, Japan

Sl0044 20358

Wakayama, Japan

Sl0044 20276

Yoshida-gun, Japan

Sl0044 50250

Cuernavaca, Mexico

Sl0044 40838

Amsterdam, Netherlands

Sl0044 40292

Groningen, Netherlands

Sl0044 40565

Maastricht, Netherlands

Sl0044 60026

Arequipa, Peru

Sl0044 60009

Surco, Peru

Sl0044 40398

Katowice, Poland

Sl0044 40795

Katowice, Poland

Sl0044 40502

Krakow, Poland

Sl0044 40037

Lublin, Poland

Sl0044 40044

Poznan, Poland

Sl0044 40484

Poznan, Poland

Sl0044 40821

Poznan, Poland

Sl0044 40097

Warsaw, Poland

Sl0044 40098

Warsaw, Poland

Sl0044 40397

Wroclaw, Poland

Sl0044 40481

Wroclaw, Poland

Sl0044 50671

Caguas, Puerto Rico

Sl0044 50683

San Juan, Puerto Rico

Sl0044 40730

Belgrade, Serbia

Sl0044 40466

Kragujevac, Serbia

Sl0044 40861

Niška Banja, Serbia

Sl0044 40392

Novi Sad, Serbia

Sl0044 20141

Busan, South Korea

Sl0044 20108

Incheon, South Korea

Sl0044 20104

Seoul, South Korea

Sl0044 20351

Seoul, South Korea

Sl0044 20092

Suwon, South Korea

Sl0044 40045

A Coruña, Spain

Sl0044 40826

Badajoz, Spain

Sl0044 40159

Barcelona, Spain

Sl0044 40160

Barcelona, Spain

Sl0044 40839

Castellon, Spain

Sl0044 40857

Madrid, Spain

Sl0044 40341

Málaga, Spain

Sl0044 40521

Mérida, Spain

Sl0044 40101

Sabadell, Spain

Sl0044 40853

Santiago de Compostela, Spain

Sl0044 40049

Seville, Spain

Sl0044 40103

Seville, Spain

Sl0044 40106

Seville, Spain

Sl0044 40863

Vitoria-Gasteiz, Spain

Sl0044 20330

New Taipei City, Taiwan

Sl0044 20080

Taichung, Taiwan

Sl0044 20113

Taichung, Taiwan

Sl0044 20142

Taichung, Taiwan

Sl0044 20086

Taipei, Taiwan

Sl0044 20099

Taipei, Taiwan

Sl0044 20082

Taoyuan, Taiwan

Sl0044 40847

Bath, United Kingdom

Sl0044 40858

Belfast, United Kingdom

Sl0044 40281

Leeds, United Kingdom

Sl0044 40864

Newcastle upon Tyne, United Kingdom

Sl0044 40701

Sheffield, United Kingdom

Sl0044 40725

West Bromwich, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (219)