NCT06617325招募中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
- 招募中
- 入组人数
- 450
- 试验地点
- 353
- 主要终点
- Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (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
- •Study participant must be ≥16 years of age, (≥18 years of age for China), 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:
- •Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)
- •Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
- •Historical evidence for anti-dsDNA antibodies
- •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 glucocorticoids and/or immunosuppressants or as stand-alone treatment if justified OR
- •Treatment with glucocorticoids 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)
排除标准
- •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 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 within the time frame (Wash-Out Period) listed 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
研究组 & 干预措施
Dapirolizumab pegol
Experimental
Study participants will receive dapriolizumab pegol throughout the Treatment Period.
干预措施: DZP (Drug)
Placebo
Placebo Comparator
Study participants will receive placebo throughout the Treatment Period.
干预措施: Placebo (Other)
结局指标
主要结局
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48
时间窗: Week 48
A study participant is a BICLA responder if all of the following is fulfilled: a. BILAG 2004 improvement without worsening, defined as BILAG 2004 Grade As at Baseline improved to B/C/D, BILAG 2004 Grade Bs at Baseline improved to C/D, and no BILAG 2004 worsening in other BILAG 2004 organ systems (that had BILAG 2004 Grade C/D/E at Baseline) such that there are no new BILAG 2004 Grades A nor greater than 1 new BILAG 2004 Grade(s) B; and b. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI- 2K) total score compared to Baseline (defined as no increase in SLEDAI-2K total score); and c. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline defined as ≤10 mm increase on a 100 mm visual analog scale Escape treatment intervention as indicated by investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.
次要结局
- Achievement of BILAG 2004 improvement without worsening at Week 48(Week 48)
- Achievement of SRI 4 response at Week 48(Week 48)
- Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48(During Treatment Period up to Week 48)
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48(Week 48)
- Achievement of LLDAS at Week 40 and maintaining LLDAS at Weeks 44 and 48(Week 40 to Week 48)
- Change from Baseline to Week 48 in the FATIGUE-PRO Total score(From Baseline to Week 48)
- Percentage of participants having a reduction in glucocorticoid dose from >7.5mg/day prednisone-equivalent dose at Baseline to ≤7.5mg/day at Week 36 and maintained through Week 48(From Baseline to Week 48)
- Change from Baseline in PGA at Week 48(From Baseline to Week 48)
- Change from Baseline in SLEDAI-2K at Week 48(From Baseline to Week 48)
- Percentage of participants with treatment-emergent adverse events (TEAEs) during the study(From Baseline until Safety Follow-Up (up to Week 54))
- Percentage of participants with serious treatment-emergent adverse events during the study(From Baseline until Safety Follow-Up (up to Week 54))
- Percentage of participants with treatment-emergent adverse events of special interest during the study(From Baseline until Safety Follow-Up (up to Week 54))
- Percentage of participants with treatment-emergent adverse events of special monitoring during the study(From Baseline until Safety Follow-Up (up to Week 54))
- Change from Baseline in FACIT-Fatigue score at Week 48(From Baseline to Week 48)
研究者
研究点 (353)
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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 yearDapirolizumab Pegol Shows Promise in Phase 3 Trial for Systemic Lupus Erythematosus- Dapirolizumab pegol (DZP) demonstrated a statistically significant 14.6% higher response rate in improving disease activity in SLE patients compared to standard of care alone.
- Participants receiving DZP experienced a 17.1% greater reduction in corticosteroid dosage, an important factor for individuals managing SLE.
- The study also revealed a 50% reduction in severe BILAG flares among patients treated with DZP plus standard of care.
- A favorable safety profile was observed, consistent with previous DZP studies, supporting its potential as a valuable treatment option.last yearDapirolizumab Pegol Shows Promise in Phase 3 Trial for Systemic Lupus Erythematosus- Dapirolizumab pegol (DZP) met the primary endpoint in the PHOENYCS GO Phase 3 trial, demonstrating statistically significant improvement in systemic lupus erythematosus (SLE) disease activity.
- Participants treated with DZP experienced a 50% reduction in severe disease flares compared to those receiving standard of care alone, highlighting the drug's potential to mitigate disease exacerbations.
- The study also revealed improvements across multiple clinical endpoints, including corticosteroid tapering and SLEDAI-2K scores, suggesting a broad impact on disease management.
- UCB and Biogen plan to initiate a second Phase 3 trial, PHOENYCS FLY, to further evaluate the efficacy and safety of dapirolizumab pegol in SLE patients.last year