NCT04294667已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 177
- 主要终点
- Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Anti-Smith (anti-Sm) antibodies (central laboratory)
- •Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
- •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
排除标准
- •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
研究组 & 干预措施
Dapirolizumab pegol
Experimental
Subjects will receive dapriolizumab pegol througout the Treatment Period.
干预措施: DZP (Drug)
Placebo
Placebo Comparator
Subjects will receive placebo througout the Treatment Period.
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48
时间窗: Week 48
Study participants were considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following were fulfilled: * 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 less than or equal to \[≤\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; and * 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 * No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as \[≤\] 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS).
次要结局
- Percentage of Participants With Achievement of BICLA Response at Week 24(Week 24)
- Percentage of Participants With Achievement of BICLA Response at Week 12(Week 12)
- Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48(During Treatment Period up to Week 48)
- Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48(During Treatment Period up to Week 48)
- Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 48(From Baseline (Day 1) to Week 48)
- Percentage of Participants With Achievement of BILAG Improvement Without Worsening at Week 48(Week 48)
- Change From Baseline in Physician's Global Assessment (PGA) at Week 48(From Baseline (Day 1) to Week 48)
- Percentage of Participants With Achievement of Systemic Lupus Erythematosus Responder Index Response - 4 (SRI-4) Response at Week 48(Week 48)
- Percentage of Participants With Achievement of Prevention of Moderate/Severe BILAG Flares (Moderate/Severe BILAG Flare-free) Through Week 48(During Treatment Period up to Week 48)
- Time to Severe BILAG Flare Through Week 48(During Treatment Period up to Week 48)
- Time to Moderate/Severe BILAG Flare Through Week 48(During Treatment Period up to Week 48)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study(From Baseline (Day 1) until Safety Follow-Up (up to Week 54))
- Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study(From Baseline (Day 1) until Safety Follow-Up (up to Week 54))
- Percentage of Participants With Treatment-emergent Adverse Events of Special Interest During the Study(From Baseline (Day 1) until Safety Follow-Up (up to Week 54))
- Percentage of Participants With Treatment-emergent Adverse Events of Special Monitoring During the Study(From Baseline (Day 1) until Safety Follow-Up (up to Week 54))
研究者
研究点 (177)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT06617325UCB Biopharma SRL450
已完成
2 期
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)NCT02804763UCB Biopharma S.P.R.L.182
已完成
3 期
A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid ArthritisRheumatoid ArthritisNCT02151851UCB Pharma SA, Belgium430
已完成
3 期
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT02413398AstraZeneca321
已完成
3 期
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and ExerciseType 2 DiabetesNCT00528372AstraZeneca1,067
相关资讯
Dapirolizumab Pegol Shows Promise in Phase 3 Trial for Systemic Lupus Erythematosus- Dapirolizumab pegol significantly reduced disease activity in patients with systemic lupus erythematosus (SLE) compared to placebo in the PHOENYCS GO Phase 3 trial.
- The trial met its primary endpoint, with a significantly higher proportion of patients achieving a BICLA response at 48 weeks with dapirolizumab pegol.
- Patients on dapirolizumab pegol experienced fewer severe disease flares and were able to reduce their corticosteroid dosage, an important benefit for long-term management.
- UCB and Biogen are planning a second Phase 3 trial, PHOENYCS FLY, to further evaluate the efficacy and safety of dapirolizumab pegol in SLE patients.last yearUCB and Biogen's Dapirolizumab Pegol Shows Promise in Phase 3 Lupus Trial- UCB and Biogen's dapirolizumab pegol met the primary endpoint in a Phase 3 trial for moderate-to-severe systemic lupus erythematosus (SLE).
- The drug demonstrated significant clinical improvement in disease activity compared to placebo when added to standard of care.
- A second Phase 3 trial, PHOENYCS FLY, is planned to further evaluate the efficacy and safety of dapirolizumab pegol in SLE patients.
- Dapirolizumab pegol targets the CD40L pathway, offering a novel approach to reduce B cell activation and autoantibody production in SLE.last year