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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Study participant must be ≥16 years of age.
  • - 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: 1.
Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry by a qualified physician. 2. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE. 3. 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
  • - 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.

    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.
    • - 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 or opportunistic 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/1.73m2, 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

    Trial Details

    Trial ID:

    This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

    NCT04294667
    Phase

    Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

    Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

    Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

    Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

    Phase 3
    Lead Sponsor

    The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

    UCB Biopharma SRL
    Principal Investigator

    The person who is responsible for the scientific and technical direction of the entire clinical study.

    UCB Cares
    Principal Investigator Affiliation 001 844 599 2273 (UCB)
    Agency Class

    Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

    Industry
    Overall Status Recruiting
    Countries Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Germany, Greece, Hungary, Korea, Republic of, Peru, Philippines, Poland, Spain, Taiwan, United States
    Conditions

    The disease, disorder, syndrome, illness, or injury that is being studied.

    Systemic Lupus Erythematosus
    Arms & Interventions

    Arms

    Experimental: Dapirolizumab pegol

    Subjects will receive dapriolizumab pegol througout the Treatment Period.

    Placebo Comparator: Placebo

    Subjects will receive placebo througout the Treatment Period.

    Interventions

    Drug: - DZP

    Subjects will receive dapirolizumab pegol at prespecified time-points.

    Other: - Placebo

    Subjects will receive placebo at prespecified time-points.

    Contact a Trial Team

    If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

    Sl0043 50052, Phoenix, Arizona

    Status

    Recruiting

    Address

    Sl0043 50052

    Phoenix, Arizona, 85032

    Sl0043 50328, Tucson, Arizona

    Status

    Recruiting

    Address

    Sl0043 50328

    Tucson, Arizona, 85704

    Sl0043 50383, Beverly Hills, California

    Status

    Recruiting

    Address

    Sl0043 50383

    Beverly Hills, California, 90211

    Sl0043 50377, El Cajon, California

    Status

    Recruiting

    Address

    Sl0043 50377

    El Cajon, California, 92020

    Sl0043 50257, La Jolla, California

    Status

    Recruiting

    Address

    Sl0043 50257

    La Jolla, California, 92037

    Sl0043 50275, La Palma, California

    Status

    Recruiting

    Address

    Sl0043 50275

    La Palma, California, 90623-1730

    Sl0043 50258, Los Angeles, California

    Status

    Recruiting

    Address

    Sl0043 50258

    Los Angeles, California, 90022

    Sl0043 50331, Poway, California

    Status

    Recruiting

    Address

    Sl0043 50331

    Poway, California, 92064

    Sl0043 50316, San Leandro, California

    Status

    Recruiting

    Address

    Sl0043 50316

    San Leandro, California, 94578

    Sl0043 50339, Denver, Colorado

    Status

    Recruiting

    Address

    Sl0043 50339

    Denver, Colorado, 80230

    Sl0043 50239, Brandon, Florida

    Status

    Recruiting

    Address

    Sl0043 50239

    Brandon, Florida, 33511

    Sl0043 50325, Miami, Florida

    Status

    Recruiting

    Address

    Sl0043 50325

    Miami, Florida, 33173

    Sl0043 50059, Ormond Beach, Florida

    Status

    Recruiting

    Address

    Sl0043 50059

    Ormond Beach, Florida, 32174

    Sl0043 50324, Plantation, Florida

    Status

    Recruiting

    Address

    Sl0043 50324

    Plantation, Florida, 33324

    Sl0043 50329, Tampa, Florida

    Status

    Recruiting

    Address

    Sl0043 50329

    Tampa, Florida, 33606

    Sl0043 50283, Tampa, Florida

    Status

    Recruiting

    Address

    Sl0043 50283

    Tampa, Florida, 33613

    Sl0043 50260, Decatur, Georgia

    Status

    Recruiting

    Address

    Sl0043 50260

    Decatur, Georgia, 30033

    Sl0043 50240, Idaho Falls, Idaho

    Status

    Recruiting

    Address

    Sl0043 50240

    Idaho Falls, Idaho, 83404

    Sl0043 50282, Bowling Green, Kentucky

    Status

    Recruiting

    Address

    Sl0043 50282

    Bowling Green, Kentucky, 42101

    Sl0043 50285, Lake Charles, Louisiana

    Status

    Recruiting

    Address

    Sl0043 50285

    Lake Charles, Louisiana, 70605

    Sl0043 50288, Cumberland, Maryland

    Status

    Recruiting

    Address

    Sl0043 50288

    Cumberland, Maryland, 21502

    Sl0043 50015, Hagerstown, Maryland

    Status

    Recruiting

    Address

    Sl0043 50015

    Hagerstown, Maryland, 21742

    Sl0043 50333, Grand Blanc, Michigan

    Status

    Recruiting

    Address

    Sl0043 50333

    Grand Blanc, Michigan, 48439

    Sl0043 50273, Las Vegas, Nevada

    Status

    Recruiting

    Address

    Sl0043 50273

    Las Vegas, Nevada, 89128

    Sl0043 50254, Bronx, New York

    Status

    Recruiting

    Address

    Sl0043 50254

    Bronx, New York, 10457

    Sl0043 50238, Charlotte, North Carolina

    Status

    Recruiting

    Address

    Sl0043 50238

    Charlotte, North Carolina, 28210

    Sl0043 50330, Cincinnati, Ohio

    Status

    Recruiting

    Address

    Sl0043 50330

    Cincinnati, Ohio, 45242

    Sl0043 50255, Columbus, Ohio

    Status

    Recruiting

    Address

    Sl0043 50255

    Columbus, Ohio, 43203

    Sl0043 50322, Oklahoma City, Oklahoma

    Status

    Recruiting

    Address

    Sl0043 50322

    Oklahoma City, Oklahoma, 73101

    Sl0043 50262, Oklahoma City, Oklahoma

    Status

    Recruiting

    Address

    Sl0043 50262

    Oklahoma City, Oklahoma, 73104

    Sl0043 50020, Duncansville, Pennsylvania

    Status

    Recruiting

    Address

    Sl0043 50020

    Duncansville, Pennsylvania, 16635

    Sl0043 50001, Jackson, Tennessee

    Status

    Recruiting

    Address

    Sl0043 50001

    Jackson, Tennessee, 38305

    Sl0043 50263, Amarillo, Texas

    Status

    Recruiting

    Address

    Sl0043 50263

    Amarillo, Texas, 79124

    Sl0043 50057, Dallas, Texas

    Status

    Recruiting

    Address

    Sl0043 50057

    Dallas, Texas, 75231

    Sl0043 50304, Dallas, Texas

    Status

    Recruiting

    Address

    Sl0043 50304

    Dallas, Texas, 75390

    Sl0043 50036, Mesquite, Texas

    Status

    Recruiting

    Address

    Sl0043 50036

    Mesquite, Texas, 75150

    Sl0043 50061, Spokane, Washington

    Status

    Recruiting

    Address

    Sl0043 50061

    Spokane, Washington, 99204

    Sl0043 50050, Beckley, West Virginia

    Status

    Recruiting

    Address

    Sl0043 50050

    Beckley, West Virginia, 25801

    International Sites

    Sl0043 60014, Tucumán, Argentina

    Status

    Recruiting

    Address

    Sl0043 60014

    Tucumán, ,

    Sl0043 30020, Parkville, Australia

    Status

    Recruiting

    Address

    Sl0043 30020

    Parkville, ,

    Sl0043 30025, St Albans, Australia

    Status

    Recruiting

    Address

    Sl0043 30025

    St Albans, ,

    Sl0043 40123, Brussels, Belgium

    Status

    Recruiting

    Address

    Sl0043 40123

    Brussels, ,

    Sl0043 40511, Bruxelles, Belgium

    Status

    Recruiting

    Address

    Sl0043 40511

    Bruxelles, ,

    Sl0043 40006, Plovdiv, Bulgaria

    Status

    Recruiting

    Address

    Sl0043 40006

    Plovdiv, ,

    Sl0043 40189, Plovdiv, Bulgaria

    Status

    Recruiting

    Address

    Sl0043 40189

    Plovdiv, ,

    Sl0043 40379, Sofia, Bulgaria

    Status

    Recruiting

    Address

    Sl0043 40379

    Sofia, ,

    Sl0043 40380, Sofia, Bulgaria

    Status

    Recruiting

    Address

    Sl0043 40380

    Sofia, ,

    Sl0043 50259, Rimouski, Canada

    Status

    Recruiting

    Address

    Sl0043 50259

    Rimouski, ,

    Sl00043 50044, Trois-Rivières, Canada

    Status

    Recruiting

    Address

    Sl00043 50044

    Trois-Rivières, ,

    Sl0043 60021, Providencia, Chile

    Status

    Recruiting

    Address

    Sl0043 60021

    Providencia, ,

    Sl0043 60015, Santiago de Chile, Chile

    Status

    Recruiting

    Address

    Sl0043 60015

    Santiago de Chile, ,

    Sl0043 60018, Santiago, Chile

    Status

    Recruiting

    Address

    Sl0043 60018

    Santiago, ,

    Sl0043 40463, Berlin, Germany

    Status

    Recruiting

    Address

    Sl0043 40463

    Berlin, ,

    Sl0043 40356, Dresden, Germany

    Status

    Recruiting

    Address

    Sl0043 40356

    Dresden, ,

    Sl0043 40462, Frankfurt, Germany

    Status

    Recruiting

    Address

    Sl0043 40462

    Frankfurt, ,

    Sl0043 40027, Herne, Germany

    Status

    Recruiting

    Address

    Sl0043 40027

    Herne, ,

    Sl0043 40078, Leipzig, Germany

    Status

    Recruiting

    Address

    Sl0043 40078

    Leipzig, ,

    Sl0043 40376, Athens, Greece

    Status

    Recruiting

    Address

    Sl0043 40376

    Athens, ,

    Sl0043 40377, Irákleion, Greece

    Status

    Recruiting

    Address

    Sl0043 40377

    Irákleion, ,

    Sl0043 40411, Debrecen, Hungary

    Status

    Recruiting

    Address

    Sl0043 40411

    Debrecen, ,

    Sl0043 40414, Pécs, Hungary

    Status

    Recruiting

    Address

    Sl0043 40414

    Pécs, ,

    Sl0043 40410, Szeged, Hungary

    Status

    Recruiting

    Address

    Sl0043 40410

    Szeged, ,

    Sl0043 40499, Székesfehérvár, Hungary

    Status

    Recruiting

    Address

    Sl0043 40499

    Székesfehérvár, ,

    Sl0043 20141, Busan, Korea, Republic of

    Status

    Recruiting

    Address

    Sl0043 20141

    Busan, ,

    Sl0043 20106, Daejeon, Korea, Republic of

    Status

    Recruiting

    Address

    Sl0043 20106

    Daejeon, ,

    Sl0043 20108, Incheon, Korea, Republic of

    Status

    Recruiting

    Address

    Sl0043 20108

    Incheon, ,

    Sl0043 20104, Seoul, Korea, Republic of

    Status

    Recruiting

    Address

    Sl0043 20104

    Seoul, ,

    Sl0043 20138, Seoul, Korea, Republic of

    Status

    Recruiting

    Address

    Sl0043 20138

    Seoul, ,

    Sl0043 20092, Suwon, Korea, Republic of

    Status

    Recruiting

    Address

    Sl0043 20092

    Suwon, ,

    Sl0043 60008, Lima, Peru

    Status

    Recruiting

    Address

    Sl0043 60008

    Lima, ,

    Sl0043 60009, Lima, Peru

    Status

    Recruiting

    Address

    Sl0043 60009

    Lima, ,

    Sl0043 60020, Miraflores, Peru

    Status

    Recruiting

    Address

    Sl0043 60020

    Miraflores, ,

    Sl0043 20110, Angeles, Philippines

    Status

    Recruiting

    Address

    Sl0043 20110

    Angeles, ,

    Sl0043 20182, Davao City, Philippines

    Status

    Recruiting

    Address

    Sl0043 20182

    Davao City, ,

    Sl0043 20181, Makati City, Philippines

    Status

    Recruiting

    Address

    Sl0043 20181

    Makati City, ,

    Sl0043 20111, Manila, Philippines

    Status

    Recruiting

    Address

    Sl0043 20111

    Manila, ,

    Sl0043 40482, Białystok, Poland

    Status

    Recruiting

    Address

    Sl0043 40482

    Białystok, ,

    Sl0043 40119, Bydgoszcz, Poland

    Status

    Recruiting

    Address

    Sl0043 40119

    Bydgoszcz, ,

    Sl0043 40398, Katowice, Poland

    Status

    Recruiting

    Address

    Sl0043 40398

    Katowice, ,

    Sl0043 40490, Kraków, Poland

    Status

    Recruiting

    Address

    Sl0043 40490

    Kraków, ,

    Sl0043 40502, Kraków, Poland

    Status

    Recruiting

    Address

    Sl0043 40502

    Kraków, ,

    Sl0043 40037, Lublin, Poland

    Status

    Recruiting

    Address

    Sl0043 40037

    Lublin, ,

    Sl0043 40151, Lublin, Poland

    Status

    Recruiting

    Address

    Sl0043 40151

    Lublin, ,

    Sl0043 40483, Nadarzyn, Poland

    Status

    Recruiting

    Address

    Sl0043 40483

    Nadarzyn, ,

    Sl0043 40044, Poznań, Poland

    Status

    Recruiting

    Address

    Sl0043 40044

    Poznań, ,

    Sl0043 40090, Poznań, Poland

    Status

    Recruiting

    Address

    Sl0043 40090

    Poznań, ,

    Sl0043 40396, Rzeszow, Poland

    Status

    Recruiting

    Address

    Sl0043 40396

    Rzeszow, ,

    Sl0043 40098, Warsaw, Poland

    Status

    Recruiting

    Address

    Sl0043 40098

    Warsaw, ,

    Sl0043 40097, Warszawa, Poland

    Status

    Recruiting

    Address

    Sl0043 40097

    Warszawa, ,

    Sl0043 40397, Wrocław, Poland

    Status

    Recruiting

    Address

    Sl0043 40397

    Wrocław, ,

    Sl0043 40045, Coruña, Spain

    Status

    Recruiting

    Address

    Sl0043 40045

    Coruña, ,

    Sl0043 40399, Murcia, Spain

    Status

    Recruiting

    Address

    Sl0043 40399

    Murcia, ,

    Sl0043 40341, Málaga, Spain

    Status

    Recruiting

    Address

    Sl0043 40341

    Málaga, ,

    Sl0043 40101, Sabadell, Spain

    Status

    Recruiting

    Address

    Sl0043 40101

    Sabadell, ,

    Sl0043 40400, Sevilla, Spain

    Status

    Recruiting

    Address

    Sl0043 40400

    Sevilla, ,

    Sl0043 40099, Vigo, Spain

    Status

    Recruiting

    Address

    Sl0043 40099

    Vigo, ,

    Sl0043 20096, Chang Hua, Taiwan

    Status

    Recruiting

    Address

    Sl0043 20096

    Chang Hua, ,

    Sl0043 20113, Taichung, Taiwan

    Status

    Recruiting

    Address

    Sl0043 20113

    Taichung, ,

    Sl0043 20086, Taipei, Taiwan

    Status

    Recruiting

    Address

    Sl0043 20086

    Taipei, ,

    Sl0043 20114, Taipei, Taiwan

    Status

    Recruiting

    Address

    Sl0043 20114

    Taipei, ,