Clinical trial NCT04976322: A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Dapirolizumab pegol
SLE
DZP
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 760
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) during the study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
measure: Incidence of serious treatment-emergent adverse events during the study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
measure: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Secondary outcomes:
measure: Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
timeFrame: Week 24
measure: Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
timeFrame: Week 52
measure: Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
timeFrame: Week 104
measure: Achievement of LLDAS at ≥50% of all visits
timeFrame: From Baseline (Day 1) until End of Treatment (Week 104)
measure: Achievement of BICLA response at Week 24
timeFrame: Week 24
measure: Achievement of BICLA response at Week 52
timeFrame: Week 52
measure: Achievement of BICLA response at Week 104
timeFrame: Week 104
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sl0046 50140
state: Alabama
city: Tucson
country: United States
facility: Sl0046 50328
state: Arizona
city: Beverly Hills
country: United States
facility: Sl0046 50383
state: California
city: La Palma
country: United States
facility: Sl0046 50275
state: California
city: San Leandro
country: United States
facility: Sl0046 50316
state: California
city: Denver
country: United States
facility: Sl0046 50339
state: Colorado
city: Brandon
country: United States
facility: Sl0046 50239
state: Florida
city: Gainesville
country: United States
facility: Sl0046 50362
state: Florida
city: Ormond Beach
country: United States
facility: Sl0046 50059
state: Florida
city: Plantation
country: United States
facility: Sl0046 50324
state: Florida
city: Tampa
country: United States
facility: Sl0046 50329
state: Florida
city: Atlanta
country: United States
facility: Sl0046 50368
state: Georgia
city: Idaho Falls
country: United States
facility: Sl0046 50240
state: Idaho
city: Hopkinsville
country: United States
facility: Sl0046 50474
state: Kentucky
city: Lake Charles
country: United States
facility: Sl0046 50285
state: Louisiana
city: Hagerstown
country: United States
facility: Sl0046 50015
state: Maryland
city: Detroit
country: United States
facility: Sl0046 50219
state: Michigan
city: Las Vegas
country: United States
facility: Sl0046 50273
state: Nevada
city: Canton
country: United States
facility: Sl0046 50366
state: New York
city: New York
country: United States
facility: Sl0046 50334
state: New York
city: Charlotte
country: United States
facility: Sl0046 50238
state: North Carolina
city: Hershey
country: United States
facility: Sl0046 50147
state: Pennsylvania
city: Jackson
country: United States
facility: Sl0046 50001
state: Tennessee
city: Colleyville
country: United States
facility: Sl0046 50418
state: Texas
city: Beckley
country: United States
facility: Sl0046 50050
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Sl0046 60002
city: Mendoza
country: Argentina
facility: Sl0046 60029
city: Quilmes
country: Argentina
facility: Sl0046 60003
city: Quilmes
country: Argentina
facility: Sl0046 60022
city: San Juan
country: Argentina
facility: Sl0046 60011
city: Tucuman
country: Argentina
facility: Sl0046 60014
city: Bruxelles
country: Belgium
facility: Sl0046 40123
city: Plovdiv
country: Bulgaria
facility: Sl0046 40189
city: Sofia
country: Bulgaria
facility: Sl0046 40380
city: Calgary
country: Canada
facility: Sl0046 50374
city: Edmonton Ab
country: Canada
facility: Sl0046 50337
city: Rimouski
country: Canada
facility: Sl0046 50259
city: Toronto
country: Canada
facility: Sl0046 50045
city: Santiago de Chile
country: Chile
facility: Sl0046 60015
city: Santiago
country: Chile
facility: Sl0046 60018
city: Barranquilla
country: Colombia
facility: Sl0046 60013
city: Barranquilla
country: Colombia
facility: Sl0046 60019
city: Bogota
country: Colombia
facility: Sl0046 60006
city: Bogota
country: Colombia
facility: Sl0046 60027
city: Bucaramanga
country: Colombia
facility: Sl0046 60016
city: Chia
country: Colombia
facility: Sl0046 60007
city: Monteria
country: Colombia
facility: Sl0046 60031
city: Praha 2
country: Czechia
facility: Sl0046 40066
city: Cologne
country: Germany
facility: Sl0046 40386
city: Freiburg
country: Germany
facility: Sl0046 40072
city: Herne
country: Germany
facility: Sl0046 40027
city: Leipzig
country: Germany
facility: Sl0046 40078
city: Tübingen
country: Germany
facility: Sl0046 40402
city: Athens
country: Greece
facility: Sl0046 40378
city: Crete
country: Greece
facility: Sl0046 40377
city: Haidari - Athens
country: Greece
facility: Sl0046 40501
city: Larisa
country: Greece
facility: Sl0046 40507
city: Budapest
country: Hungary
facility: Sl0046 40412
city: Debrecen
country: Hungary
facility: Sl0046 40411
city: Szeged
country: Hungary
facility: Sl0046 40031
city: Szekesfehervar
country: Hungary
facility: Sl0046 40499
city: Catania
country: Italy
facility: Sl0046 40084
city: Milano
country: Italy
facility: Sl0046 40448
city: Incheon
country: Korea, Republic of
facility: Sl0046 20108
city: Seoul
country: Korea, Republic of
facility: Sl0046 20104
city: Chihuahua
country: Mexico
facility: Sl0046 50317
city: Cuernavaca
country: Mexico
facility: Sl0046 50250
city: Guadalajara
country: Mexico
facility: Sl0046 50249
city: Leon
country: Mexico
facility: Sl0046 50271
city: Merida
country: Mexico
facility: Sl0046 50252
city: Monterrey
country: Mexico
facility: Sl0046 50251
city: Lima
country: Peru
facility: Sl0046 60009
city: Lima
country: Peru
facility: Sl0046 60023
city: Davao
country: Philippines
facility: Sl0046 20182
city: Makati
country: Philippines
facility: Sl0046 20181
city: Bialystok
country: Poland
facility: Sl0046 40482
city: Bydgoszcz
country: Poland
facility: Sl0046 40119
city: Katowice
country: Poland
facility: Sl0046 40398
city: Krakow
country: Poland
facility: Sl0046 40502
city: Lublin
country: Poland
facility: Sl0046 40151
city: Poznan
country: Poland
facility: Sl0046 40044
city: Poznan
country: Poland
facility: Sl0046 40090
city: Warszawa
country: Poland
facility: Sl0046 40097
city: Warszawa
country: Poland
facility: Sl0046 40098
city: Wroclaw
country: Poland
facility: Sl0046 40397
city: Wroclaw
country: Poland
facility: Sl0046 40481
city: Galati
country: Romania
facility: Sl0046 40382
city: Belgrade
country: Serbia
facility: Sl0046 40393
city: Belgrade
country: Serbia
facility: Sl0046 40461
city: Barcelona
country: Spain
facility: Sl0046 40160
city: Málaga
country: Spain
facility: Sl0046 40341
city: Sabadell
country: Spain
facility: Sl0046 40101
city: Vigo
country: Spain
facility: Sl0046 40099
city: Taichung City
country: Taiwan
facility: Sl0046 20113
city: Taichung City
country: Taiwan
facility: Sl0046 20142
city: Taipei City
country: Taiwan
facility: Sl0046 20095
city: Taiyuan CITY
country: Taiwan
facility: Sl0046 20082
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: