A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
PHOENYCS FLY
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
4 other identifiers
interventional
450
22 countries
225
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2024
Typical duration for phase_3
225 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
November 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
May 1, 2026
April 1, 2026
3.5 years
September 24, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48
A study participant is a BICLA responder if all of the following is fulfilled: a. BILAG 2004 improvement without worsening, defined as BILAG 2004 Grade As at Baseline improved to B/C/D, BILAG 2004 Grade Bs at Baseline improved to C/D, and no BILAG 2004 worsening in other BILAG 2004 organ systems (that had BILAG 2004 Grade C/D/E at Baseline) such that there are no new BILAG 2004 Grades A nor greater than 1 new BILAG 2004 Grade(s) B; and b. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI- 2K) total score compared to Baseline (defined as no increase in SLEDAI-2K total score); and c. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline defined as ≤10 mm increase on a 100 mm visual analog scale Escape treatment intervention as indicated by investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.
Week 48
Secondary Outcomes (14)
Achievement of SRI 4 response at Week 48
Week 48
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
Week 48
Achievement of LLDAS at Week 40 and maintaining LLDAS at Weeks 44 and 48
Week 40 to Week 48
Change from Baseline to Week 48 in the FATIGUE-PRO Total score
From Baseline to Week 48
Percentage of participants having a reduction in glucocorticoid dose from >7.5mg/day prednisone-equivalent dose at Baseline to ≤7.5mg/day at Week 36 and maintained through Week 48
From Baseline to Week 48
- +9 more secondary outcomes
Study Arms (2)
Dapirolizumab pegol
EXPERIMENTALStudy participants will receive dapriolizumab pegol throughout the Treatment Period.
Placebo
PLACEBO COMPARATORStudy participants will receive placebo throughout the Treatment Period.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)
- Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
- Historical evidence for anti-dsDNA antibodies
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (225)
Sl0044 50058
Avondale, Arizona, 85392, United States
Sl0044 50550
Chandler, Arizona, 85225, United States
Sl0044 50713
Gilbert, Arizona, 85297, United States
Sl0044 50662
Glendale, Arizona, 85306, United States
Sl0044 50052
Phoenix, Arizona, 85032, United States
Sl0044 50677
Scottsdale, Arizona, 85258, United States
Sl0044 50670
Searcy, Arkansas, 72143, United States
Sl0044 50737
Beverly Hills, California, 90210, United States
Sl0044 50775
Beverly Hills, California, 90211, United States
Sl0044 50257
La Jolla, California, 92037, United States
Sl0044 50275
La Palma, California, 90623-1730, United States
Sl0044 50755
Los Alamitos, California, 90720, United States
Sl0044 50258
Los Angeles, California, 90022, United States
Sl0044 50725
Menifee, California, 92586, United States
Sl0044 50340
Orange, California, 92868, United States
Sl0044 50316
San Leandro, California, 94578, United States
Sl0044 50719
Aurora, Colorado, 80045, United States
Sl0044 50239
Brandon, Florida, 33511, United States
Sl0044 50630
Clearwater, Florida, 33765, United States
Sl0044 50747
Coral Gables, Florida, 33134, United States
Sl0044 50751
Coral Gables, Florida, 33134, United States
Sl0044 50362
Gainesville, Florida, 32610, United States
Sl0044 50763
Margate, Florida, 33063, United States
Sl0044 50735
Miami, Florida, 33155, United States
Sl0044 50681
Miami, Florida, 33172, United States
Sl0044 50324
Plantation, Florida, 33324, United States
Sl0044 50698
Tampa, Florida, 33614, United States
Sl0044 50585
Winter Park, Florida, 32789, United States
Sl0044 50566
Gainesville, Georgia, 30501-2418, United States
Sl0044 50659
Marietta, Georgia, 30152, United States
Sl0044 50699
Chicago, Illinois, 60616, United States
Sl0044 50717
Willowbrook, Illinois, 60527, United States
Sl0044 50748
New Albany, Indiana, 47150, United States
Sl0044 50319
Iowa City, Iowa, 52242., United States
Sl0044 50074
Kansas City, Kansas, 66160, United States
Sl0044 50586
Louisville, Kentucky, 40202-5700, United States
Sl0044 50023
Baton Rouge, Louisiana, 70836, United States
Sl0044 50285
Lake Charles, Louisiana, 70605, United States
Sl0044 50660
New Orleans, Louisiana, 70112, United States
Sl0044 50730
Rockville, Maryland, 20850, United States
Sl0044 50219
Detroit, Michigan, 48201, United States
Sl0044 50682
Kansas City, Missouri, 64151, United States
Sl0044 50010
Brooklyn, New York, 11201, United States
Sl0044 50264
Manhasset, New York, 11030, United States
Sl0044 50077
New York, New York, 10021, United States
Sl0044 50241
Syracuse, New York, 13210, United States
Sl0044 50238
Charlotte, North Carolina, 28211, United States
Sl0044 50365
Pittsburgh, Pennsylvania, 15213, United States
Sl0044 50001
Jackson, Tennessee, 38305, United States
Sl0044 50693
Murfreesboro, Tennessee, 37128, United States
Sl0044 50562
Allen, Texas, 75013, United States
Sl0044 50738
Bellaire, Texas, 77401, United States
Sl0044 50673
Fort Worth, Texas, 76109, United States
Sl0044 50723
Houston, Texas, 77002, United States
Sl0044 50688
Houston, Texas, 77054, United States
Sl0044 50696
Houston, Texas, 77090, United States
Sl0044 50773
Irving, Texas, 75061, United States
Sl0044 50718
Mansfield, Texas, 76063, United States
Sl0044 50036
Mesquite, Texas, 75150, United States
Sl0044 50061
Spokane Valley, Washington, 99216, 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 40896
Bordeaux, France
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 40897
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 20362
Taipei, Taiwan
Sl0044 20082
Taoyuan City, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Central Study Contacts
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
September 24, 2024
First Posted
September 27, 2024
Study Start
November 21, 2024
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
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.
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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.