A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
NCT ID: NCT06617325
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2024-11-21
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dapirolizumab pegol
Study participants will receive dapriolizumab pegol throughout the Treatment Period.
DZP
Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
Placebo
Study participants will receive placebo throughout the Treatment Period.
Placebo
Study participants will receive placebo at prespecified time-points.
Interventions
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DZP
Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
Placebo
Study participants will receive placebo at prespecified time-points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR
* Treatment with corticosteroids 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 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 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 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 defined 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
16 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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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 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 50630
Clearwater, Florida, United States
Sl0044 50751
Coral Gables, Florida, United States
Sl0044 50362
Gainesville, 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 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 50718
Mansfield, Texas, United States
Sl0044 50036
Mesquite, Texas, United States
Sl0044 50061
Spokane, 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 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 20290
Guilin, , China
Sl0044 20271
Haikou, , China
Sl0044 20296
Hangzhou, , China
Sl0044 20185
Jinan, , 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 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 20273
Yangzhou, , China
Sl0044 20132
Zhengzhou, , China
Sl0044 40513
Copenhagen, , Denmark
Sl0044 40489
Odense, , Denmark
Sl0044 40848
Le Mans, , France
Sl0044 40506
Montpellier, , France
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 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
Padua, , Italy
Sl0044 40176
Pisa, , Italy
Sl0044 40148
Roma, , Italy
Sl0044 40675
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 20076
Shinjuku-ku, , Japan
Sl0044 20285
Shinjuku-ku, , Japan
Sl0044 20032
Suita, , Japan
Sl0044 20277
Suita, , Japan
Sl0044 20278
Tsu, , Japan
Sl0044 20276
Yoshida-gun, , Japan
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 40821
Poznan, , Poland
Sl0044 40097
Warsaw, , Poland
Sl0044 40098
Warsaw, , 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 40392
Novi Sad, , Serbia
Sl0044 20141
Busan, , South Korea
Sl0044 20104
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 20330
New Taipei City, , Taiwan
Sl0044 20080
Taichung, , Taiwan
Sl0044 20142
Taichung, , Taiwan
Sl0044 20086
Taipei, , Taiwan
Sl0044 20099
Taipei, , Taiwan
Sl0044 20082
Taoyuan, , Taiwan
Sl0044 40847
Bath, , United Kingdom
Sl0044 40281
Leeds, , United Kingdom
Countries
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Central Contacts
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UCB Cares
Role: CONTACT
Phone: 001 844 599 2273
Other Identifiers
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2019-003407-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508191-11
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1298-3467
Identifier Type: OTHER
Identifier Source: secondary_id
SL0044
Identifier Type: -
Identifier Source: org_study_id