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

NCT04294667 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: SL00432019-003406-27
• Study Type: interventional
• Target: 321
• Locations: 24 countries
• Sites: 175

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

Keywords

Systemic lupus erythematosus; Dapirolizumab pegol; SLE; DZP

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48

  Study participants were considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following were fulfilled: * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[≤\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; and * No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and * No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as \[≤\] 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS).

  Week 48

Secondary Outcomes (15)

• Percentage of Participants With Achievement of BICLA Response at Week 24

  Week 24

• Percentage of Participants With Achievement of BICLA Response at Week 12

  Week 12

• Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48

  During Treatment Period up to Week 48

• Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48

  During Treatment Period up to Week 48

• Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 48

  From Baseline (Day 1) to Week 48

Study Arms (2)

Dapirolizumab pegol

EXPERIMENTAL

Subjects will receive dapriolizumab pegol througout the Treatment Period.

Drug: DZP

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo througout the Treatment Period.

Other: Placebo

Interventions

DZP DRUG

Subjects will receive dapirolizumab pegol at prespecified time-points.

Also known as: CDP7657

Dapirolizumab pegol

Placebo OTHER

Subjects will receive placebo at prespecified time-points.

Also known as: PBO

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participant must be ≥16 years of age, 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 SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as:
• a. Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry 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 (in central laboratory at Screening) ii) Either complement C3 \< lower limit of normal (LLN) OR complement C4 \<LLN OR elevated erythrocyte-bound complement C4d (where available) 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:
• \. Anti-Smith (anti-Sm) antibodies (central laboratory) 2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory) 3. Historic evidence for anti-dsDNA antibodies
• 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 Screening Visit AND
• SLEDAI-2K without labs ≥4 at Baseline Visit
• e. Receiving the following SOC medication at stable dose:
• Antimalarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible

You may not qualify if:

• 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
• Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
• Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
• Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
• Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
• Study participant had a reactivated latent infection (example, 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 clinically significant active or latent infection
• Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
• Study participant takes any protocol defined prohibited concomitant medication
• Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
• Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (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 \<30mL/min/1.73m\^2, or serum creatinine \>2.5 mg/dL, or participant has proteinuria \>3 g/day, or protein: creatinine ratio \>340 mg/mmol at the Screening Visit

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (177)

Sl0043 50140

Birmingham, Alabama, 35205, United States

Location

Sl0043 50052

Phoenix, Arizona, 85032, United States

Location

Sl0043 50328

Tucson, Arizona, 85704, United States

Location

Sl0043 50383

Beverly Hills, California, 90211, United States

Location

Sl0043 50257

La Jolla, California, 92037, United States

Location

Sl0043 50275

La Palma, California, 90623-1730, United States

Location

Sl0043 50378

Loma Linda, California, 92354, United States

Location

Sl0043 50258

Los Angeles, California, 90022, United States

Location

Sl0043 50340

Orange, California, 92868, United States

Location

Sl0043 50331

Poway, California, 92064, United States

Location

Sl0043 50377

San Diego, California, 92108, United States

Location

Sl0043 50316

San Leandro, California, 94578, United States

Location

Sl0043 50339

Denver, Colorado, 80230, United States

Location

Sl0043 50367

New Haven, Connecticut, 06519, United States

Location

Sl0043 50341

Washington D.C., District of Columbia, 20060, United States

Location

Sl0043 50239

Brandon, Florida, 33511, United States

Location

Sl0043 50362

Gainesville, Florida, 32610, United States

Location

Sl0043 50122

Miami, Florida, 33136, United States

Location

Sl0043 50059

Ormond Beach, Florida, 32174, United States

Location

Sl0043 50324

Plantation, Florida, 33324, United States

Location

Sl0043 50329

Tampa, Florida, 33606, United States

Location

Sl0043 50283

Tampa, Florida, 33613, United States

Location

Sl0043 50368

Atlanta, Georgia, 30303, United States

Location

Sl0043 50382

Atlanta, Georgia, 30309, United States

Location

Sl0043 50240

Idaho Falls, Idaho, 83404, United States

Location

Sl0043 50310

Chicago, Illinois, 60612, United States

Location

Sl0043 50360

Skokie, Illinois, 60076, United States

Location

Sl0043 50474

Hopkinsville, Kentucky, 42240-1746, United States

Location

Sl0043 50285

Lake Charles, Louisiana, 70605, United States

Location

Sl0043 50288

Cumberland, Maryland, 21502, United States

Location

Sl0043 50015

Hagerstown, Maryland, 21740, United States

Location

Sl0043 50219

Detroit, Michigan, 48201, United States

Location

Sl0043 50333

Grand Blanc, Michigan, 48439, United States

Location

Sl0043 50273

Las Vegas, Nevada, 89128, United States

Location

Sl0043 50010

Brooklyn, New York, 11201, United States

Location

Sl0043 50366

Canton, New York, 13617, United States

Location

Sl0043 50266

Great Neck, New York, 11021, United States

Location

Sl0043 50264

Manhasset, New York, 11030, United States

Location

Sl0043 50077

New York, New York, 10021, United States

Location

Sl0043 50334

New York, New York, 10032, United States

Location

Sl0043 50241

Syracuse, New York, 13210, United States

Location

Sl0043 50238

Charlotte, North Carolina, 28211, United States

Location

Sl0043 50179

Winston-Salem, North Carolina, 27157-1010, United States

Location

Sl0043 50330

Cincinnati, Ohio, 45242, United States

Location

Sl0043 50262

Oklahoma City, Oklahoma, 73104, United States

Location

Sl0043 50020

Duncansville, Pennsylvania, 16635, United States

Location

Sl0043 50147

Hershey, Pennsylvania, 17033, United States

Location

Sl0043 50364

Philadelphia, Pennsylvania, 19107, United States

Location

Sl0043 50365

Pittsburgh, Pennsylvania, 15232, United States

Location

Sl0043 50001

Jackson, Tennessee, 38305, United States

Location

Sl0043 50263

Amarillo, Texas, 79124, United States

Location

Sl0043 50338

Bellaire, Texas, 77401, United States

Location

Sl0043 50418

Colleyville, Texas, 76034, United States

Location

Sl0043 50057

Dallas, Texas, 75231, United States

Location

Sl0043 50304

Dallas, Texas, 75390, United States

Location

Sl0043 50036

Mesquite, Texas, 75150, United States

Location

Sl0043 50267

Seattle, Washington, 98195, United States

Location

Sl0043 50061

Spokane, Washington, 99204, United States

Location

Sl0043 50050

Beckley, West Virginia, 25801, United States

Location

Sl0043 50321

Morgantown, West Virginia, 26505, United States

Location

Sl0043 60002

Capital Federal, Argentina

Location

Sl0043 60001

Ciudad Autonoma de Buenos AIRE, Argentina

Location

Sl0043 60029

Mendoza, Argentina

Location

Sl0043 60003

Quilmes, Argentina

Location

Sl0043 60022

Quilmes, Argentina

Location

Sl0043 60011

San Juan, Argentina

Location

Sl0043 60014

San Miguel de Tucumán, Argentina

Location

Sl0043 30020

Parkville, Australia

Location

Sl0043 30025

St Albans, Australia

Location

Sl0043 40388

Graz, Austria

Location

Sl0043 40387

Vienna, Austria

Location

Sl0043 40123

Brussels, Belgium

Location

Sl0043 40060

Liège, Belgium

Location

Sl0043 40006

Plovdiv, Bulgaria

Location

Sl0043 40189

Plovdiv, Bulgaria

Location

Sl0043 40522

Plovdiv, Bulgaria

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Sl0043 40380

Sofia, Bulgaria

Location

Sl0043 50374

Calgary, Canada

Location

Sl0043 50337

Edmonton, Canada

Location

Sl0043 50259

Rimouski, Canada

Location

Sl0043 50045

Toronto, Canada

Location

Sl0043 50044

Trois-Rivières, Canada

Location

Sl0043 60021

Providencia, Santiago, Chile

Location

Sl0043 60015

Santiago, Chile

Location

Sl0043 60018

Santiago, Chile

Location

Sl0043 60030

Santiago, Chile

Location

Sl0043 60013

Barranquilla, Colombia

Location

Sl0043 60019

Barranquilla, Colombia

Location

Sl0043 60006

Bogotá, Colombia

Location

Sl0043 60027

Bogotá, Colombia

Location

Sl0043 60016

Bucaramanga, Colombia

Location

Sl0043 60007

Chía, Colombia

Location

Sl0043 60028

Medellín, Colombia

Location

Sl0043 60031

Montería, Colombia

Location

Sl0043 40066

Prague, Czechia

Location

Sl0043 40489

Odense, Denmark

Location

Sl0043 40506

Montpellier, France

Location

Sl0043 40505

Paris, France

Location

Sl0043 40386

Cologne, Germany

Location

Sl0043 40322

Dessau, Germany

Location

Sl0043 40356

Dresden, Germany

Location

Sl0043 40072

Freiburg im Breisgau, Germany

Location

Sl0043 40024

Hanover, Germany

Location

Sl0043 40027

Herne, Germany

Location

Sl0043 40078

Leipzig, Germany

Location

Sl0043 40402

Tübingen, Germany

Location

Sl0043 40378

Athens, Greece

Location

Sl0043 40377

Crete, Greece

Location

Sl0043 40501

Haidari - Athens, Greece

Location

Sl0043 40507

Larissa, Greece

Location

Sl0043 40375

Thessaloniki, Greece

Location

Sl0043 40412

Budapest, Hungary

Location

Sl0043 40411

Debrecen, Hungary

Location

Sl0043 40413

Gyula, Hungary

Location

Sl0043 40031

Szeged, Hungary

Location

Sl0043 40499

Székesfehérvár, Hungary

Location

Sl0043 40084

Catania, Italy

Location

Sl0043 40472

Ferrara, Italy

Location

Sl0043 40514

Genova, Italy

Location

Sl0043 40291

Milan, Italy

Location

Sl0043 40448

Milan, Italy

Location

Sl0043 40471

Milan, Italy

Location

Sl0043 40509

Padua, Italy

Location

Sl0043 40148

Roma, Italy

Location

Sl0043 40492

Rozzano, Italy

Location

Sl0043 50317

Chihuahua City, Mexico

Location

Sl0043 50250

Cuernavaca, Mexico

Location

Sl0043 50249

Guadalajara, Mexico

Location

Sl0043 50271

León, Mexico

Location

Sl0043 50252

Mérida, Mexico

Location

Sl0043 50251

Monterrey, Mexico

Location

Sl0043 60026

Arequipa, Peru

Location

Sl0043 60008

Lima, Peru

Location

Sl0043 60009

Lima, Peru

Location

Sl0043 60023

Lima, Peru

Location

Sl0043 20110

Angeles, Philippines

Location

Sl0043 20182

Davao City, Philippines

Location

Sl0043 20181

Makati, Philippines

Location

Sl0043 20111

Manila, Philippines

Location

Sl0043 40482

Bialystok, Poland

Location

Sl0043 40119

Bydgoszcz, Poland

Location

Sl0043 40398

Katowice, Poland

Location

Sl0043 40490

Krakow, Poland

Location

Sl0043 40502

Krakow, Poland

Location

Sl0043 40037

Lublin, Poland

Location

Sl0043 40151

Lublin, Poland

Location

Sl0043 40483

Nadarzyn, Poland

Location

Sl0043 40044

Poznan, Poland

Location

Sl0043 40090

Poznan, Poland

Location

Sl0043 40097

Warsaw, Poland

Location

Sl0043 40098

Warsaw, Poland

Location

Sl0043 40394

Warsaw, Poland

Location

Sl0043 40397

Wroclaw, Poland

Location

Sl0043 40481

Wroclaw, Poland

Location

Sl0043 40383

Bucharest, Romania

Location

Sl0043 40464

Bucharest, Romania

Location

Sl0043 40382

Galati, Romania

Location

Sl0043 40393

Belgrade, Serbia

Location

Sl0043 40461

Belgrade, Serbia

Location

Sl0043 40466

Kragujevac, Serbia

Location

Sl0043 40392

Novi Sad, Serbia

Location

Sl0043 20141

Busan, South Korea

Location

Sl0043 20106

Daejeon, South Korea

Location

Sl0043 20108

Incheon, South Korea

Location

Sl0043 20104

Seoul, South Korea

Location

Sl0043 40045

A Coruña, Spain

Location

Sl0043 40160

Barcelona, Spain

Location

Sl0043 40341

Málaga, Spain

Location

Sl0043 40521

Mérida, Spain

Location

Sl0043 40101

Sabadell, Spain

Location

Sl0043 40400

Seville, Spain

Location

Sl0043 40099

Vigo, Spain

Location

Sl0043 20113

Taichung, Taiwan

Location

Sl0043 20142

Taichung, Taiwan

Location

Sl0043 20095

Taipei, Taiwan

Location

Sl0043 20099

Taipei, Taiwan

Location

Sl0043 20082

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

dapirolizumab pegol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 4, 2020
• Study Start: August 12, 2020
• Primary Completion: May 22, 2024
• Study Completion: June 4, 2024
• Last Updated: May 4, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

BU (4); FR (2); RO (3); GR (5); KR (4); ME (6); TW (5); PH (4); HU (5); SE (4); CZ (1); ES (7); AU (2); CA (5); AR (7); US (60); IT (9); PL (15); BE (2); CL (4); PE (4); DK (1); CO (8); DE (8)