Clinical trial NCT04294667: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Dapirolizumab pegol
SLE
DZP
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 321
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes
* Study participant must be ≥16 years of age, 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 SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as:

  a. Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry 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 (in central laboratory at Screening) ii) Either complement C3 \< lower limit of normal (LLN) OR complement C4 \<LLN OR elevated erythrocyte-bound complement C4d (where available) 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:

  1. Anti-Smith (anti-Sm) antibodies (central laboratory) 2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory) 3. Historic evidence for anti-dsDNA antibodies

  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 Screening Visit AND
* SLEDAI-2K without labs ≥4 at Baseline Visit

  e. Receiving the following SOC medication at stable dose:
  * Antimalarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible

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
* Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
* Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
* Study participant had a reactivated latent infection (example, 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 clinically significant active or latent infection
* Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
* Study participant takes any protocol defined prohibited concomitant medication
* Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
* Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (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 \<30mL/min/1.73m\^2, or serum creatinine \>2.5 mg/dL, or participant has proteinuria \>3 g/day, or protein: creatinine ratio \>340 mg/mmol at the Screening Visit

Primary outcomes:
measure: Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With Achievement of BICLA Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Achievement of BICLA Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48
timeFrame: During Treatment Period up to Week 48
measure: Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48
timeFrame: During Treatment Period up to Week 48
measure: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 48
timeFrame: From Baseline (Day 1) to Week 48
measure: Percentage of Participants With Achievement of BILAG Improvement Without Worsening at Week 48
timeFrame: Week 48
measure: Change From Baseline in Physician's Global Assessment (PGA) at Week 48
timeFrame: From Baseline (Day 1) to Week 48
measure: Percentage of Participants With Achievement of Systemic Lupus Erythematosus Responder Index Response - 4 (SRI-4) Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Achievement of Prevention of Moderate/Severe BILAG Flares (Moderate/Severe BILAG Flare-free) Through Week 48
timeFrame: During Treatment Period up to Week 48
measure: Time to Severe BILAG Flare Through Week 48
timeFrame: During Treatment Period up to Week 48
measure: Time to Moderate/Severe BILAG Flare Through Week 48
timeFrame: During Treatment Period up to Week 48
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
measure: Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
measure: Percentage of Participants With Treatment-emergent Adverse Events of Special Interest During the Study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
measure: Percentage of Participants With Treatment-emergent Adverse Events of Special Monitoring During the Study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sl0043 50140
state: Alabama
city: Phoenix
country: United States
facility: Sl0043 50052
state: Arizona
city: Tucson
country: United States
facility: Sl0043 50328
state: Arizona
city: Beverly Hills
country: United States
facility: Sl0043 50383
state: California
city: La Jolla
country: United States
facility: Sl0043 50257
state: California
city: La Palma
country: United States
facility: Sl0043 50275
state: California
city: Loma Linda
country: United States
facility: Sl0043 50378
state: California
city: Los Angeles
country: United States
facility: Sl0043 50258
state: California
city: Orange
country: United States
facility: Sl0043 50340
state: California
city: Poway
country: United States
facility: Sl0043 50331
state: California
city: San Diego
country: United States
facility: Sl0043 50377
state: California
city: San Leandro
country: United States
facility: Sl0043 50316
state: California
city: Denver
country: United States
facility: Sl0043 50339
state: Colorado
city: New Haven
country: United States
facility: Sl0043 50367
state: Connecticut
city: Washington
country: United States
facility: Sl0043 50341
state: District of Columbia
city: Brandon
country: United States
facility: Sl0043 50239
state: Florida
city: Gainesville
country: United States
facility: Sl0043 50362
state: Florida
city: Miami
country: United States
facility: Sl0043 50122
state: Florida
city: Ormond Beach
country: United States
facility: Sl0043 50059
state: Florida
city: Plantation
country: United States
facility: Sl0043 50324
state: Florida
city: Tampa
country: United States
facility: Sl0043 50329
state: Florida
city: Tampa
country: United States
facility: Sl0043 50283
state: Florida
city: Atlanta
country: United States
facility: Sl0043 50368
state: Georgia
city: Atlanta
country: United States
facility: Sl0043 50382
state: Georgia
city: Idaho Falls
country: United States
facility: Sl0043 50240
state: Idaho
city: Chicago
country: United States
facility: Sl0043 50310
state: Illinois
city: Skokie
country: United States
facility: Sl0043 50360
state: Illinois
city: Hopkinsville
country: United States
facility: Sl0043 50474
state: Kentucky
city: Lake Charles
country: United States
facility: Sl0043 50285
state: Louisiana
city: Cumberland
country: United States
facility: Sl0043 50288
state: Maryland
city: Hagerstown
country: United States
facility: Sl0043 50015
state: Maryland
city: Detroit
country: United States
facility: Sl0043 50219
state: Michigan
city: Grand Blanc
country: United States
facility: Sl0043 50333
state: Michigan
city: Las Vegas
country: United States
facility: Sl0043 50273
state: Nevada
city: Brooklyn
country: United States
facility: Sl0043 50010
state: New York
city: Canton
country: United States
facility: Sl0043 50366
state: New York
city: Great Neck
country: United States
facility: Sl0043 50266
state: New York
city: Manhasset
country: United States
facility: Sl0043 50264
state: New York
city: New York
country: United States
facility: Sl0043 50077
state: New York
city: New York
country: United States
facility: Sl0043 50334
state: New York
city: Syracuse
country: United States
facility: Sl0043 50241
state: New York
city: Charlotte
country: United States
facility: Sl0043 50238
state: North Carolina
city: Winston-Salem
country: United States
facility: Sl0043 50179
state: North Carolina
city: Cincinnati
country: United States
facility: Sl0043 50330
state: Ohio
city: Oklahoma City
country: United States
facility: Sl0043 50262
state: Oklahoma
city: Duncansville
country: United States
facility: Sl0043 50020
state: Pennsylvania
city: Hershey
country: United States
facility: Sl0043 50147
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sl0043 50364
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Sl0043 50365
state: Pennsylvania
city: Jackson
country: United States
facility: Sl0043 50001
state: Tennessee
city: Amarillo
country: United States
facility: Sl0043 50263
state: Texas
city: Bellaire
country: United States
facility: Sl0043 50338
state: Texas
city: Colleyville
country: United States
facility: Sl0043 50418
state: Texas
city: Dallas
country: United States
facility: Sl0043 50057
state: Texas
city: Dallas
country: United States
facility: Sl0043 50304
state: Texas
city: Mesquite
country: United States
facility: Sl0043 50036
state: Texas
city: Seattle
country: United States
facility: Sl0043 50267
state: Washington
city: Spokane
country: United States
facility: Sl0043 50061
state: Washington
city: Beckley
country: United States
facility: Sl0043 50050
state: West Virginia
city: Morgantown
country: United States
facility: Sl0043 50321
state: West Virginia
city: Capital Federal
country: Argentina
facility: Sl0043 60002
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Sl0043 60001
city: Mendoza
country: Argentina
facility: Sl0043 60029
city: Quilmes
country: Argentina
facility: Sl0043 60003
city: Quilmes
country: Argentina
facility: Sl0043 60022
city: San Juan
country: Argentina
facility: Sl0043 60011
city: Tucuman
country: Argentina
facility: Sl0043 60014
city: Parkville
country: Australia
facility: Sl0043 30020
city: St Albans
country: Australia
facility: Sl0043 30025
city: Graz
country: Austria
facility: Sl0043 40388
city: Wien
country: Austria
facility: Sl0043 40387
city: Bruxelles
country: Belgium
facility: Sl0043 40123
city: Liege
country: Belgium
facility: Sl0043 40060
city: Plovdiv
country: Bulgaria
facility: Sl0043 40006
city: Plovdiv
country: Bulgaria
facility: Sl0043 40189
city: Plovdiv
country: Bulgaria
facility: Sl0043 40522
city: Sofia
country: Bulgaria
facility: Sl0043 40380
city: Calgary
country: Canada
facility: Sl0043 50374
city: Edmonton
country: Canada
facility: Sl0043 50337
city: Rimouski
country: Canada
facility: Sl0043 50259
city: Toronto
country: Canada
facility: Sl0043 50045
city: Trois-rivieres
country: Canada
facility: Sl0043 50044
city: Providencia, Santiago
country: Chile
facility: Sl0043 60021
city: Santiago de Chile
country: Chile
facility: Sl0043 60015
city: Santiago
country: Chile
facility: Sl0043 60018
city: Santiago
country: Chile
facility: Sl0043 60030
city: Barranquilla
country: Colombia
facility: Sl0043 60013
city: Barranquilla
country: Colombia
facility: Sl0043 60019
city: Bogota
country: Colombia
facility: Sl0043 60006
city: Bogota
country: Colombia
facility: Sl0043 60027
city: Bucaramanga
country: Colombia
facility: Sl0043 60016
city: Chia
country: Colombia
facility: Sl0043 60007
city: Medellín
country: Colombia
facility: Sl0043 60028
city: Monteria
country: Colombia
facility: Sl0043 60031
city: Praha 2
country: Czechia
facility: Sl0043 40066
city: Odense
country: Denmark
facility: Sl0043 40489
city: Montpellier Cedex 5
country: France
facility: Sl0043 40506
city: Paris Cedex 12
country: France
facility: Sl0043 40505
city: Cologne
country: Germany
facility: Sl0043 40386
city: Dessau
country: Germany
facility: Sl0043 40322
city: Dresden
country: Germany
facility: Sl0043 40356
city: Freiburg
country: Germany
facility: Sl0043 40072
city: Hanover
country: Germany
facility: Sl0043 40024
city: Herne
country: Germany
facility: Sl0043 40027
city: Leipzig
country: Germany
facility: Sl0043 40078
city: Tübingen
country: Germany
facility: Sl0043 40402
city: Athens
country: Greece
facility: Sl0043 40378
city: Crete
country: Greece
facility: Sl0043 40377
city: Haidari - Athens
country: Greece
facility: Sl0043 40501
city: Larisa
country: Greece
facility: Sl0043 40507
city: Thessaloniki
country: Greece
facility: Sl0043 40375
city: Budapest
country: Hungary
facility: Sl0043 40412
city: Debrecen
country: Hungary
facility: Sl0043 40411
city: Gyula
country: Hungary
facility: Sl0043 40413
city: Szeged
country: Hungary
facility: Sl0043 40031
city: Szekesfehervar
country: Hungary
facility: Sl0043 40499
city: Catania
country: Italy
facility: Sl0043 40084
city: Ferrara
country: Italy
facility: Sl0043 40472
city: Genova
country: Italy
facility: Sl0043 40514
city: Milano
country: Italy
facility: Sl0043 40291
city: Milano
country: Italy
facility: Sl0043 40448
city: Milano
country: Italy
facility: Sl0043 40471
city: Padova
country: Italy
facility: Sl0043 40509
city: Roma
country: Italy
facility: Sl0043 40148
city: Rozzano
country: Italy
facility: Sl0043 40492
city: Busan
country: Korea, Republic of
facility: Sl0043 20141
city: Daejeon
country: Korea, Republic of
facility: Sl0043 20106
city: Incheon
country: Korea, Republic of
facility: Sl0043 20108
city: Seoul
country: Korea, Republic of
facility: Sl0043 20104
city: Chihuahua
country: Mexico
facility: Sl0043 50317
city: Cuernavaca
country: Mexico
facility: Sl0043 50250
city: Guadalajara
country: Mexico
facility: Sl0043 50249
city: Leon
country: Mexico
facility: Sl0043 50271
city: Merida
country: Mexico
facility: Sl0043 50252
city: Monterrey
country: Mexico
facility: Sl0043 50251
city: Arequipa
country: Peru
facility: Sl0043 60026
city: Lima
country: Peru
facility: Sl0043 60008
city: Lima
country: Peru
facility: Sl0043 60009
city: Lima
country: Peru
facility: Sl0043 60023
city: Angeles
country: Philippines
facility: Sl0043 20110
city: Davao
country: Philippines
facility: Sl0043 20182
city: Makati
country: Philippines
facility: Sl0043 20181
city: Manila
country: Philippines
facility: Sl0043 20111
city: Bialystok
country: Poland
facility: Sl0043 40482
city: Bydgoszcz
country: Poland
facility: Sl0043 40119
city: Katowice
country: Poland
facility: Sl0043 40398
city: Krakow
country: Poland
facility: Sl0043 40490
city: Krakow
country: Poland
facility: Sl0043 40502
city: Lublin
country: Poland
facility: Sl0043 40037
city: Lublin
country: Poland
facility: Sl0043 40151
city: Nadarzyn
country: Poland
facility: Sl0043 40483
city: Poznan
country: Poland
facility: Sl0043 40044
city: Poznan
country: Poland
facility: Sl0043 40090
city: Warszawa
country: Poland
facility: Sl0043 40097
city: Warszawa
country: Poland
facility: Sl0043 40098
city: Warszawa
country: Poland
facility: Sl0043 40394
city: Wroclaw
country: Poland
facility: Sl0043 40397
city: Wroclaw
country: Poland
facility: Sl0043 40481
city: Bucharest
country: Romania
facility: Sl0043 40464
city: Bucuresti
country: Romania
facility: Sl0043 40383
city: Galati
country: Romania
facility: Sl0043 40382
city: Belgrade
country: Serbia
facility: Sl0043 40393
city: Belgrade
country: Serbia
facility: Sl0043 40461
city: Kragujevac
country: Serbia
facility: Sl0043 40466
city: Novi Sad
country: Serbia
facility: Sl0043 40392
city: A Coruna
country: Spain
facility: Sl0043 40045
city: Barcelona
country: Spain
facility: Sl0043 40160
city: Málaga
country: Spain
facility: Sl0043 40341
city: Mérida
country: Spain
facility: Sl0043 40521
city: Sabadell
country: Spain
facility: Sl0043 40101
city: Sevilla
country: Spain
facility: Sl0043 40400
city: Vigo
country: Spain
facility: Sl0043 40099
city: Taichung City
country: Taiwan
facility: Sl0043 20113
city: Taichung City
country: Taiwan
facility: Sl0043 20142
city: Taipei City
country: Taiwan
facility: Sl0043 20099
city: Taipei
country: Taiwan
facility: Sl0043 20095
city: Taoyuan City
country: Taiwan
facility: Sl0043 20082
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: