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By invitation only Phase 3 NCT04976322

A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Phase 3 – large-scale trial before approval
Conditions: Systemic Lupus Erythematosus

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Who can participate
Inclusion Criteria: * 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 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 or ongoing malignancies at the start of the study
Interventions
Dapirolizumab pegol
DRUG
Locations 104
Argentina (6)
Sl0046 60002
Buenos Aires
Sl0046 60029
Mendoza
Sl0046 60003
Quilmes
Sl0046 60022
Quilmes
Sl0046 60011
San Juan
Sl0046 60014
San Miguel de Tucumán
Belgium (1)
Sl0046 40123
Brussels
Bulgaria (2)
Sl0046 40189
Plovdiv
Sl0046 40380
Sofia
Canada (4)
Sl0046 50374
Calgary
Sl0046 50337
Edmonton AB
Sl0046 50259
Rimouski
Sl0046 50045
Toronto
Chile (2)
Sl0046 60015
Santiago
Sl0046 60018
Santiago
China (4)
Sl0046 20019
Guangzhou
Sl0046 20136
Tianjin
Sl0046 20180
Wuhan
Sl0046 20132
Zhengzhou
Colombia (7)
Sl0046 60013
Barranquilla
Sl0046 60019
Barranquilla
Sl0046 60006
Bogotá
Sl0046 60027
Bogotá
Sl0046 60016
Bucaramanga
Sl0046 60007
Chía
Sl0046 60031
Montería
Czech Republic (1)
Sl0046 40066
Prague
Germany (5)
Sl0046 40386
Cologne
Sl0046 40072
Freiburg im Breisgau
Sl0046 40027
Herne
Sl0046 40078
Leipzig
Sl0046 40402
Tübingen
Greece (4)
Sl0046 40378
Athens
Sl0046 40501
Athens
Sl0046 40377
Crete
Sl0046 40507
Larissa
Hungary (4)
Sl0046 40412
Budapest
Sl0046 40411
Debrecen
Sl0046 40031
Szeged
Sl0046 40499
Székesfehérvár
Italy (2)
Sl0046 40084
Catania
Sl0046 40448
Milan
Japan (1)
Sl0046 20031
Sapporo
Mexico (6)
Sl0046 50317
Chihuahua City
Sl0046 50250
Cuernavaca
Sl0046 50249
Guadalajara
Sl0046 50271
León
Sl0046 50252
Mérida
Sl0046 50251
Monterrey
Peru (2)
Sl0046 60009
Lima
Sl0046 60023
Lima
Philippines (2)
Sl0046 20182
Davao City
Sl0046 20181
Makati
Poland (11)
Sl0046 40482
Bialystok
Sl0046 40119
Bydgoszcz
Sl0046 40398
Katowice
Sl0046 40502
Krakow
Sl0046 40151
Lublin
Sl0046 40044
Poznan
Sl0046 40090
Poznan
Sl0046 40097
Warsaw
Sl0046 40098
Warsaw
Sl0046 40397
Wroclaw
Sl0046 40481
Wroclaw
Romania (1)
Sl0046 40382
Galati
Serbia (2)
Sl0046 40393
Belgrade
Sl0046 40461
Belgrade
South Korea (2)
Sl0046 20108
Incheon
Sl0046 20104
Seoul
Spain (4)
Sl0046 40160
Barcelona
Sl0046 40341
Málaga
Sl0046 40101
Sabadell
Sl0046 40099
Vigo
Taiwan (4)
Sl0046 20113
Taichung
Sl0046 20142
Taichung
Sl0046 20095
Taipei
Sl0046 20082
Taiyuan
United States (27)
Sl0046 50368
Atlanta , Georgia
Sl0046 50050
Beckley , West Virginia
Sl0046 50383
Beverly Hills , California
Sl0046 50140
Birmingham , Alabama
Sl0046 50239
Brandon , Florida
Sl0046 50366
Canton , New York
Sl0046 50238
Charlotte , North Carolina
Sl0046 50418
Colleyville , Texas
Sl0046 50339
Denver , Colorado
Sl0046 50219
Detroit , Michigan
Sl0046 50362
Gainesville , Florida
Sl0046 50015
Hagerstown , Maryland
Sl0046 50147
Hershey , Pennsylvania
Sl0046 50474
Hopkinsville , Kentucky
Sl0046 50240
Idaho Falls , Idaho
Sl0046 50001
Jackson , Tennessee
Sl0046 50275
La Palma , California
Sl0046 50285
Lake Charles , Louisiana
Sl0046 50273
Las Vegas , Nevada
Sl0046 50264
Manhasset , New York
Sl0046 50681
Miami , Florida
Sl0046 50334
New York , New York
Sl0046 50059
Ormond Beach , Florida
Sl0046 50324
Plantation , Florida
Sl0046 50316
San Leandro , California
Sl0046 50329
Tampa , Florida
Sl0046 50328
Tucson , Arizona
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
16 Years
Healthy volunteers
No
Start date
27.07.2021
Completion date
07.08.2030
Registry ID
NCT04976322
Source
clinicaltrials.gov
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