A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
- Registration Number
- NCT04976322
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 760
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dapirolizumab pegol Dapirolizumab pegol Subjects will receive dapriolizumab pegol throughout the Treatment Period.
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) during the study From Baseline (Day 1) until Safety Follow-Up (up to Week 110) 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.
Incidence of serious treatment-emergent adverse events during the study From Baseline (Day 1) until Safety Follow-Up (up to Week 110) 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 aboveIncidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation From Baseline (Day 1) until Safety Follow-Up (up to Week 110) 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.
- Secondary Outcome Measures
Name Time Method Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24 Week 24 BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52 Week 52 BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104 Week 104 BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Achievement of LLDAS at ≥50% of all visits From Baseline (Day 1) until End of Treatment (Week 104) Low lupus disease activity state (LLDAS) is defined as:
* No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever)
* No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit
* PGA ≤33 mm
* Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day
* Stable standard maintenance doses of immunosuppressive drugs as allowed by protocolAchievement of BICLA response at Week 24 Week 24 A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled:
1. 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 ≤1 new B.); and
2. 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
3. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale
The parent studies Baseline will be used as reference point.Achievement of BICLA response at Week 52 Week 52 A study participant is considered to be a BICLA responder if all of the following is fulfilled:
1. 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 ≤1 new B.); and
2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale
The parent studies Baseline will be used as reference point.Achievement of BICLA response at Week 104 Week 104 A study participant is considered to be a BICLA responder if all of the following is fulfilled:
1. 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 ≤1 new B.); and
2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale
The parent studies Baseline will be used as reference point.
Trial Locations
- Locations (97)
Sl0046 50273
🇺🇸Las Vegas, Nevada, United States
Sl0046 50366
🇺🇸Canton, New York, United States
Sl0046 50334
🇺🇸New York, New York, United States
Sl0046 50238
🇺🇸Charlotte, North Carolina, United States
Sl0046 50147
🇺🇸Hershey, Pennsylvania, United States
Sl0046 50001
🇺🇸Jackson, Tennessee, United States
Sl0046 50418
🇺🇸Colleyville, Texas, United States
Sl0046 50050
🇺🇸Beckley, West Virginia, 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
🇦🇷Tucuman, Argentina
Sl0046 40123
🇧🇪Bruxelles, 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 de Chile, Chile
Sl0046 60018
🇨🇱Santiago, Chile
Sl0046 60013
🇨🇴Barranquilla, Colombia
Sl0046 60019
🇨🇴Barranquilla, Colombia
Sl0046 60006
🇨🇴Bogota, Colombia
Sl0046 60027
🇨🇴Bogota, Colombia
Sl0046 60016
🇨🇴Bucaramanga, Colombia
Sl0046 60007
🇨🇴Chia, Colombia
Sl0046 60031
🇨🇴Monteria, Colombia
Sl0046 40066
🇨🇿Praha 2, Czechia
Sl0046 40386
🇩🇪Cologne, Germany
Sl0046 40072
🇩🇪Freiburg, Germany
Sl0046 40027
🇩🇪Herne, Germany
Sl0046 40078
🇩🇪Leipzig, Germany
Sl0046 40402
🇩🇪Tübingen, Germany
Sl0046 40378
🇬🇷Athens, Greece
Sl0046 40377
🇬🇷Crete, Greece
Sl0046 40501
🇬🇷Haidari - Athens, Greece
Sl0046 40507
🇬🇷Larisa, Greece
Sl0046 40412
🇭🇺Budapest, Hungary
Sl0046 40411
🇭🇺Debrecen, Hungary
Sl0046 40031
🇭🇺Szeged, Hungary
Sl0046 40499
🇭🇺Szekesfehervar, Hungary
Sl0046 40084
🇮🇹Catania, Italy
Sl0046 40448
🇮🇹Milano, Italy
Sl0046 20108
🇰🇷Incheon, Korea, Republic of
Sl0046 20104
🇰🇷Seoul, Korea, Republic of
Sl0046 50317
🇲🇽Chihuahua, Mexico
Sl0046 50250
🇲🇽Cuernavaca, Mexico
Sl0046 50249
🇲🇽Guadalajara, Mexico
Sl0046 50271
🇲🇽Leon, Mexico
Sl0046 50252
🇲🇽Merida, Mexico
Sl0046 50251
🇲🇽Monterrey, Mexico
Sl0046 60009
🇵🇪Lima, Peru
Sl0046 60023
🇵🇪Lima, Peru
Sl0046 20182
🇵🇭Davao, 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
🇵🇱Warszawa, Poland
Sl0046 40098
🇵🇱Warszawa, Poland
Sl0046 40397
🇵🇱Wroclaw, Poland
Sl0046 40481
🇵🇱Wroclaw, Poland
Sl0046 40382
🇷🇴Galati, Romania
Sl0046 40393
🇷🇸Belgrade, Serbia
Sl0046 50219
🇺🇸Detroit, Michigan, United States
Sl0046 50140
🇺🇸Birmingham, Alabama, United States
Sl0046 50328
🇺🇸Tucson, Arizona, United States
Sl0046 50383
🇺🇸Beverly Hills, California, United States
Sl0046 50275
🇺🇸La Palma, California, United States
Sl0046 50316
🇺🇸San Leandro, California, United States
Sl0046 50339
🇺🇸Denver, Colorado, United States
Sl0046 50239
🇺🇸Brandon, Florida, United States
Sl0046 50362
🇺🇸Gainesville, Florida, United States
Sl0046 50059
🇺🇸Ormond Beach, Florida, United States
Sl0046 50324
🇺🇸Plantation, Florida, United States
Sl0046 50329
🇺🇸Tampa, Florida, United States
Sl0046 50368
🇺🇸Atlanta, Georgia, United States
Sl0046 50240
🇺🇸Idaho Falls, Idaho, United States
Sl0046 50474
🇺🇸Hopkinsville, Kentucky, United States
Sl0046 50285
🇺🇸Lake Charles, Louisiana, United States
Sl0046 50015
🇺🇸Hagerstown, Maryland, United States
Sl0046 40461
🇷🇸Belgrade, Serbia
Sl0046 40160
🇪🇸Barcelona, Spain
Sl0046 40341
🇪🇸Málaga, Spain
Sl0046 40101
🇪🇸Sabadell, Spain
Sl0046 40099
🇪🇸Vigo, Spain
Sl0046 20113
🇨🇳Taichung City, Taiwan
Sl0046 20142
🇨🇳Taichung City, Taiwan
Sl0046 20095
🇨🇳Taipei City, Taiwan
Sl0046 20082
🇨🇳Taiyuan CITY, Taiwan