A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus
4 other identifiers
interventional
760
23 countries
106
Brief Summary
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2021
Longer than P75 for phase_3
106 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
July 14, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedStudy Start
First participant enrolled
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 7, 2030
May 1, 2026
April 1, 2026
9 years
July 14, 2021
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of treatment-emergent adverse events (TEAEs) during the study
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of serious treatment-emergent adverse events during the study
A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment.
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Secondary Outcomes (7)
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
Week 24
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
Week 52
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
Week 104
Achievement of LLDAS at ≥50% of all visits
From Baseline (Day 1) until End of Treatment (Week 104)
Achievement of BICLA response at Week 24
Week 24
- +2 more secondary outcomes
Study Arms (1)
Dapirolizumab pegol
EXPERIMENTALSubjects will receive dapriolizumab pegol throughout the Treatment Period.
Interventions
Subjects will receive dapirolizumab pegol at prespecified time-points.
Eligibility Criteria
You may qualify if:
- The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
- The participant completed one of the parent studies within 4 weeks prior to entry to this study
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 or ongoing malignancies at the start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Sl0046 50140
Birmingham, Alabama, 35294, United States
Sl0046 50328
Tucson, Arizona, 85704, United States
Sl0046 50383
Beverly Hills, California, 90210, United States
Sl0046 50275
La Palma, California, 90623-1730, United States
Sl0046 50316
San Leandro, California, 94578, United States
Sl0046 50339
Denver, Colorado, 80230, United States
Sl0046 50239
Brandon, Florida, 33511, United States
Sl0046 50362
Gainesville, Florida, 32610, United States
Sl0046 50681
Miami, Florida, 33172, United States
Sl0046 50059
Ormond Beach, Florida, 32174, United States
Sl0046 50324
Plantation, Florida, 33324, United States
Sl0046 50329
Tampa, Florida, 33606, United States
Sl0046 50698
Tampa, Florida, 33614, United States
Sl0046 50368
Atlanta, Georgia, 30303, United States
Sl0046 50240
Idaho Falls, Idaho, 83404, United States
Sl0046 50474
Hopkinsville, Kentucky, 42240-1746, United States
Sl0046 50285
Lake Charles, Louisiana, 70605, United States
Sl0046 50015
Hagerstown, Maryland, 21740, United States
Sl0046 50219
Detroit, Michigan, 48201, United States
Sl0046 50273
Las Vegas, Nevada, 89128, United States
Sl0046 50366
Canton, New York, 13617, United States
Sl0046 50264
Manhasset, New York, 11030, United States
Sl0046 50334
New York, New York, 10032, United States
Sl0046 50238
Charlotte, North Carolina, 28211, United States
Sl0046 50147
Hershey, Pennsylvania, 17033, United States
Sl0046 50001
Jackson, Tennessee, 38305, United States
Sl0046 50418
Colleyville, Texas, 76034, United States
Sl0046 50050
Beckley, West Virginia, 25801, United States
Sl0046 60002
Buenos Aires, Argentina
Sl0046 60029
Mendoza, Argentina
Sl0046 60003
Quilmes, Argentina
Sl0046 60022
Quilmes, Argentina
Sl0046 60011
San Juan, Argentina
Sl0046 60014
San Miguel de Tucumán, Argentina
Sl0046 40123
Brussels, Belgium
Sl0046 40189
Plovdiv, Bulgaria
Sl0046 40380
Sofia, Bulgaria
Sl0046 50374
Calgary, Canada
Sl0046 50337
Edmonton AB, Canada
Sl0046 50259
Rimouski, Canada
Sl0046 50045
Toronto, Canada
Sl0046 60015
Santiago, Chile
Sl0046 60018
Santiago, Chile
Sl0046 20291
Changchun, China
Sl0046 20019
Guangzhou, China
Sl0046 20136
Tianjin, China
Sl0046 20180
Wuhan, China
Sl0046 20132
Zhengzhou, China
Sl0046 60013
Barranquilla, Colombia
Sl0046 60019
Barranquilla, Colombia
Sl0046 60006
Bogotá, Colombia
Sl0046 60027
Bogotá, Colombia
Sl0046 60016
Bucaramanga, Colombia
Sl0046 60007
Chía, Colombia
Sl0046 60031
Montería, Colombia
Sl0046 40066
Prague, Czechia
Sl0046 40386
Cologne, Germany
Sl0046 40072
Freiburg im Breisgau, Germany
Sl0046 40027
Herne, Germany
Sl0046 40078
Leipzig, Germany
Sl0046 40402
Tübingen, Germany
Sl0046 40378
Athens, Greece
Sl0046 40501
Athens, Greece
Sl0046 40377
Crete, Greece
Sl0046 40507
Larissa, Greece
Sl0046 40412
Budapest, Hungary
Sl0046 40411
Debrecen, Hungary
Sl0046 40031
Szeged, Hungary
Sl0046 40499
Székesfehérvár, Hungary
Sl0046 40084
Catania, Italy
Sl0046 40448
Milan, Italy
Sl0046 20031
Sapporo, Japan
Sl0046 50317
Chihuahua City, Mexico
Sl0046 50250
Cuernavaca, Mexico
Sl0046 50249
Guadalajara, Mexico
Sl0046 50271
León, Mexico
Sl0046 50252
Mérida, Mexico
Sl0046 50251
Monterrey, Mexico
Sl0046 60009
Lima, Peru
Sl0046 60023
Lima, Peru
Sl0046 20182
Davao City, Philippines
Sl0046 20181
Makati, Philippines
Sl0046 40482
Bialystok, Poland
Sl0046 40119
Bydgoszcz, Poland
Sl0046 40398
Katowice, Poland
Sl0046 40502
Krakow, Poland
Sl0046 40151
Lublin, Poland
Sl0046 40044
Poznan, Poland
Sl0046 40090
Poznan, Poland
Sl0046 40097
Warsaw, Poland
Sl0046 40098
Warsaw, Poland
Sl0046 40397
Wroclaw, Poland
Sl0046 40481
Wroclaw, Poland
Sl0046 40382
Galati, Romania
Sl0046 40393
Belgrade, Serbia
Sl0046 40461
Belgrade, Serbia
Sl0046 20108
Incheon, South Korea
Sl0046 20104
Seoul, South Korea
Sl0046 40160
Barcelona, Spain
Sl0046 40341
Málaga, Spain
Sl0046 40101
Sabadell, Spain
Sl0046 40099
Vigo, Spain
Sl0046 20113
Taichung, Taiwan
Sl0046 20142
Taichung, Taiwan
Sl0046 20095
Taipei, Taiwan
Sl0046 20082
Taiyuan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2021
First Posted
July 26, 2021
Study Start
July 27, 2021
Primary Completion (Estimated)
August 7, 2030
Study Completion (Estimated)
August 7, 2030
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.