Clinical trial NCT06617325: 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: RECRUITING
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Dapirolizumab pegol
SLE
DZP
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 450
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:

* 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 systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:

  a. Diagnosed with SLE at least 24 weeks before the Screening Visit 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 (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \<lower limit of normal (LLN) OR complement C4 \<LLN 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 or source verifiable history)
  2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
  3. Historical evidence for anti-dsDNA antibodies
  4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) 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 the Screening Visit AND
     * SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications 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 antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)

     Exclusion Criteria:
* Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric 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. This includes systemic reactions due to latex allergy
* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \[eg, curettage, electrodesiccation\] not later than 4 weeks prior to the Screening Visit \[V1\]), 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 a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
* Study participant has clinically significant active or latent infection
* Study participant had a reactivated latent infection (eg, 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 used the prohibited medications defined in the Protocol
* Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
* Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the 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 (eGFR) \<30 mL/min/1.73m2, or serum creatinine \>2.5 mg/dL, or participant has proteinuria \>3g/day, or protein:creatinine ratio \>340 mg/mmol at the Screening Visit

Primary outcomes:
measure: Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24
timeFrame: Week 24
measure: Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 12
timeFrame: Week 12
measure: Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
timeFrame: During Treatment Period up to Week 48
measure: Achievement of LLDAS in ≥50% of post Baseline visits through Week 48
timeFrame: During Treatment Period up to Week 48
measure: Change from Baseline in SLEDAI-2K at Week 48
timeFrame: From Baseline (Day 1) to Week 48
measure: Achievement of BILAG 2004 improvement without worsening at Week 48
timeFrame: Week 48
measure: Change from Baseline in PGA at Week 48
timeFrame: From Baseline (Day 1) to Week 48
measure: Achievement of SRI 4 response at Week 48
timeFrame: Week 48
measure: 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: Avondale
country: United States
facility: Sl0044 50058
state: Arizona
city: Chandler
country: United States
facility: Sl0044 50550
state: Arizona
city: Glendale
country: United States
facility: Sl0044 50662
state: Arizona
city: Phoenix
country: United States
facility: Sl0044 50052
state: Arizona
city: Searcy
country: United States
facility: Sl0044 50670
state: Arkansas
city: La Palma
country: United States
facility: Sl0044 50275
state: California
city: Los Angeles
country: United States
facility: Sl0044 50258
state: California
city: Orange
country: United States
facility: Sl0044 50340
state: California
city: San Leandro
country: United States
facility: Sl0044 50316
state: California
city: Clearwater
country: United States
facility: Sl0044 50630
state: Florida
city: Miami
country: United States
facility: Sl0044 50681
state: Florida
city: Plantation
country: United States
facility: Sl0044 50324
state: Florida
city: Tampa
country: United States
facility: Sl0044 50698
state: Florida
city: Winter Park
country: United States
facility: Sl0044 50585
state: Florida
city: Gainesville
country: United States
facility: Sl0044 50566
state: Georgia
city: Marietta
country: United States
facility: Sl0044 50659
state: Georgia
city: Chicago
country: United States
facility: Sl0044 50699
state: Illinois
city: Willowbrook
country: United States
facility: Sl0044 50717
state: Illinois
city: Lake Charles
country: United States
facility: Sl0044 50285
state: Louisiana
city: New Orleans
country: United States
facility: Sl0044 50660
state: Louisiana
city: Detroit
country: United States
facility: Sl0044 50219
state: Michigan
city: Brooklyn
country: United States
facility: Sl0044 50010
state: New York
city: Manhasset
country: United States
facility: Sl0044 50264
state: New York
city: New York
country: United States
facility: Sl0044 50077
state: New York
city: Charlotte
country: United States
facility: Sl0044 50238
state: North Carolina
city: Jackson
country: United States
facility: Sl0044 50001
state: Tennessee
city: Murfreesboro
country: United States
facility: Sl0044 50693
state: Tennessee
city: Allen
country: United States
facility: Sl0044 50562
state: Texas
city: Houston
country: United States
facility: Sl0044 50688
state: Texas
city: Houston
country: United States
facility: Sl0044 50696
state: Texas
city: Mesquite
country: United States
facility: Sl0044 50036
state: Texas
city: Spokane
country: United States
facility: Sl0044 50061
state: Washington
city: C.a.b.a
country: Argentina
facility: Sl0044 60004
city: Capital Federal
country: Argentina
facility: Sl0044 60002
city: Mendoza
country: Argentina
facility: Sl0044 60029
city: Quilmes
country: Argentina
facility: Sl0044 60003
city: San Juan
country: Argentina
facility: Sl0044 60011
city: Tucuman
country: Argentina
facility: Sl0044 60014
city: Leuven
country: Belgium
facility: Sl0044 40002
city: Baotou
country: China
facility: Sl0044 20293
city: Beijing
country: China
facility: Sl0044 20128
city: Beijing
country: China
facility: Sl0044 20157
city: Beijing
country: China
facility: Sl0044 20173
city: Bengbu
country: China
facility: Sl0044 20201
city: Chang ZHOU
country: China
facility: Sl0044 20186
city: Changchun
country: China
facility: Sl0044 20291
city: Changsha
country: China
facility: Sl0044 20295
city: Guangzhou
country: China
facility: Sl0044 20019
city: Guilin
country: China
facility: Sl0044 20290
city: Haikou
country: China
facility: Sl0044 20271
city: Hangzhou
country: China
facility: Sl0044 20296
city: Jinan
country: China
facility: Sl0044 20185
city: Nanchang
country: China
facility: Sl0044 20192
city: Nanjing
country: China
facility: Sl0044 20024
city: Pingxiang
country: China
facility: Sl0044 20272
city: Shanghai
country: China
facility: Sl0044 20020
city: Shanghai
country: China
facility: Sl0044 20172
city: Suzhou
country: China
facility: Sl0044 20204
city: Tianjin
country: China
facility: Sl0044 20136
city: Urumuqi
country: China
facility: Sl0044 20275
city: Wenzhou
country: China
facility: Sl0044 20025
city: Wuhan
country: China
facility: Sl0044 20180
city: Wuhan
country: China
facility: Sl0044 20270
city: Xi'an
country: China
facility: Sl0044 20274
city: Yangzhou
country: China
facility: Sl0044 20273
city: Zhengzhou
country: China
facility: Sl0044 20132
city: Copenhagen
country: Denmark
facility: Sl0044 40513
city: Odense
country: Denmark
facility: Sl0044 40489
city: Cologne
country: Germany
facility: Sl0044 40386
city: DESSAU-ROßLAU
country: Germany
facility: Sl0044 40322
city: Dresden
country: Germany
facility: Sl0044 40356
city: Freiburg
country: Germany
facility: Sl0044 40072
city: Greifswald
country: Germany
facility: Sl0044 40717
city: Herne
country: Germany
facility: Sl0044 40027
city: Jena
country: Germany
facility: Sl0044 40139
city: Köln
country: Germany
facility: Sl0044 40716
city: Leipzig
country: Germany
facility: Sl0044 40078
city: Vogelsang-gommern
country: Germany
facility: Sl0044 40715
city: Athens
country: Greece
facility: Sl0044 40376
city: Athens
country: Greece
facility: Sl0044 40501
city: Heraklion
country: Greece
facility: Sl0044 40377
city: Larissa
country: Greece
facility: Sl0044 40507
city: Genova
country: Italy
facility: Sl0044 40514
city: Milano
country: Italy
facility: Sl0044 40291
city: Milano
country: Italy
facility: Sl0044 40471
city: Padova
country: Italy
facility: Sl0044 40509
city: Pisa
country: Italy
facility: Sl0044 40176
city: Roma
country: Italy
facility: Sl0044 40148
city: Bunkyo-ku
country: Japan
facility: Sl0044 20035
city: Bunkyo-ku
country: Japan
facility: Sl0044 20196
city: Bunkyo-ku
country: Japan
facility: Sl0044 20279
city: Chuo-ku
country: Japan
facility: Sl0044 20030
city: Fukuoka
country: Japan
facility: Sl0044 20281
city: Fukuoka
country: Japan
facility: Sl0044 20282
city: Kawagoe
country: Japan
facility: Sl0044 20039
city: Kita-gun
country: Japan
facility: Sl0044 20045
city: Kitakyushu
country: Japan
facility: Sl0044 20065
city: Meguro-ku
country: Japan
facility: Sl0044 20069
city: Nagasaki
country: Japan
facility: Sl0044 20071
city: Nagoya
country: Japan
facility: Sl0044 20287
city: Sagamihara
country: Japan
facility: Sl0044 20283
city: Saga
country: Japan
facility: Sl0044 20084
city: Sapporo
country: Japan
facility: Sl0044 20031
city: Sasebo
country: Japan
facility: Sl0044 20042
city: Sendai-shi
country: Japan
facility: Sl0044 20171
city: Shinjuku-ku
country: Japan
facility: Sl0044 20076
city: Shinjuku-ku
country: Japan
facility: Sl0044 20285
city: Suita
country: Japan
facility: Sl0044 20032
city: Suita
country: Japan
facility: Sl0044 20277
city: TSU
country: Japan
facility: Sl0044 20278
city: Yoshida-gun
country: Japan
facility: Sl0044 20276
city: Busan
country: Korea, Republic of
facility: Sl0044 20141
city: Seoul
country: Korea, Republic of
facility: Sl0044 20104
city: Suwon-si
country: Korea, Republic of
facility: Sl0044 20092
city: Amsterdam
country: Netherlands
facility: Sl0044 40838
city: Katowice
country: Poland
facility: Sl0044 40398
city: Katowice
country: Poland
facility: Sl0044 40795
city: Krakow
country: Poland
facility: Sl0044 40502
city: Lublin
country: Poland
facility: Sl0044 40037
city: Poznan
country: Poland
facility: Sl0044 40044
city: Poznan
country: Poland
facility: Sl0044 40821
city: Warszawa
country: Poland
facility: Sl0044 40097
city: Warszawa
country: Poland
facility: Sl0044 40098
city: Wroclaw
country: Poland
facility: Sl0044 40481
city: Caguas
country: Puerto Rico
facility: Sl0044 50671
city: San Juan
country: Puerto Rico
facility: Sl0044 50683
city: Kragujevac
country: Serbia
facility: Sl0044 40466
city: Novi Sad
country: Serbia
facility: Sl0044 40392
city: A Coruna
country: Spain
facility: Sl0044 40045
city: Badajoz
country: Spain
facility: Sl0044 40826
city: Barcelona
country: Spain
facility: Sl0044 40159
city: Barcelona
country: Spain
facility: Sl0044 40160
city: Málaga
country: Spain
facility: Sl0044 40341
city: Sabadell
country: Spain
facility: Sl0044 40101
city: Sevilla
country: Spain
facility: Sl0044 40103
city: Taichung City
country: Taiwan
facility: Sl0044 20142
city: Taichung
country: Taiwan
facility: Sl0044 20080
city: Taipei City
country: Taiwan
facility: Sl0044 20086
city: Taipei City
country: Taiwan
facility: Sl0044 20099
city: Taiyuan CITY
country: Taiwan
facility: Sl0044 20082
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: