NCT07840287尚未招募3 期
A Phase 3, Single-Arm, Open-Label, Long-Term Extension Study To Evaluate The Safety And Efficacy Of Enpatoran In Participants With Active Cutaneous Manifestations Of Lupus Erythematosus With Or Without Systemic Disease Receiving Standard Of Care [Elowen-LTE]
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 404
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001) (NCT07332481) and Elowen-2 (MS504908_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include:
Study Duration: 120 weeks. Treatment Duration: 108 weeks. Visit Frequency: Every 4 weeks (from Week 4 to Week 24) and every 12 weeks (from Week 36 to Week 120).
Study Intervention: Enpatoran. Intervention Form: Film-coated tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
- •Are participants with active cutaneous manifestations of lupus erythematosus that have successfully completed the 24-week treatment of the Elowen-1 or Elowen-2 study, including the Week 24 end of treatment (EOT) visit.
排除标准
- •Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical condition, or any other reason, in the opinion of the Investigator that would preclude participation in this LTE study.
- •Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgment of the Investigator, would make the participant inappropriate to participate in this LTE study.
- •Active clinically significant viral (including Severe Acute Respiratory Syndrome Coronavirus [SARS CoV] 2), bacterial (including active tuberculosis or untreated latent tuberculosis), parasitic, or fungal infection or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered sufficiently controlled will not be exclusionary.
- •Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor.
- •All participants who entered Elowen-1 and Elowen-2 studies with positive anti-hepatitis B core (HBc) antibody and/or anti hepatitis B surface (HBs) antibody with non-detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at Screening must provide a negative HBV DNA polymerase chain reaction (PCR) result.
- •Received LTE-prohibited medication during participation in Elowen 1 or Elowen-2 study or after Elowen-1 or Elowen-2 study Week 24/EOT visit (may require prior discussion with Medical Monitor).
- •Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit.
- •Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal.
- •Planned major elective medical or surgical procedure.
研究组 & 干预措施
Enpatoran
Experimental
干预措施: Enpatoran (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
时间窗: From current LTE study Day 1 to Week 120
次要结局
- Percentage of Participants With Sustained LLDAS(From LTE study Day 1 to Week 108)
- Number of Participants With Abnormalities in Laboratory Parameters (greater than or equal to [>=] Grade 3)(From current LTE study Day 1 to Week 120)
- Number of Participants With Abnormalities in Vital Signs(From current LTE study Day 1 to Week 120)
- Number of Participants With Abnormalities in Electrocardiogram (ECG) Parameter(From current LTE study Day 1 to Week 120)
- Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline(Elowen-1/Elowen-2 study Baseline, current LTE study Week 108)
- Percentage of Participants With CLASI-50 Response, Defined as >= 50% Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline(Elowen-1/Elowen-2 study Baseline, current LTE study Week 108)
- Percentage of Participants With CLASI-A less than and equal to (<=) 3(From current LTE study Day 1 to Week 108)
- Change From Elowen-1/Elowen-2 Study Baseline in Worst Itch Numeric Rating Scale (NRS) Through LTE Week 108(Elowen 1/Elowen-2 study Baseline, current LTE study Week 108)
- Percentage of Participants With Worst Itch Response Through LTE Week 108 Based on Elowen-1/Elowen-2 study Baseline(Elowen 1/Elowen-2 study Baseline, current LTE study Week 108)
- Percentage of Participants With CLA-IGA-R Other Morphological Characteristics (OMC) Score of 0 or 1 and at Least a 1-Point Reduction From Elowen 1/Elowen-2 study Baseline to LTE study Week 108(Elowen 1/Elowen-2 study Baseline, current LTE study Week 108)
- Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response(Elowen 1/Elowen-2 study Baseline, current LTE study Week 108)
- Percentage of Participants With Mild/Moderate and Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Flare(From current LTE study Baseline to Week 108)
- Time to First Severe SELENA-SLEDAI Flare(From current LTE study Baseline to Week 108)
- Percentage of Participants with BILAG Moderate to Severe Flares(From current LTE study Baseline to Week 108)
- Time to First Moderate/Severe BILAG Flare(From current LTE study Baseline to Week 108)
- Percentage of Participants With Lupus Low Disease Activity State (LLDAS) Attainment(From LTE study Day 1 to Week 108)
- Change in Prednisone-equivalent Corticosteroid (CS) Dose From Elowen-1/Elowen-2 Study Baseline to LTE Study Week 108(Elowen-1/Elowen-2 study Baseline, current LTE study Week 108)
- Percentage of Participants With CS Reduction of Daily Prednisone Equivalent Dose(Elowen-1/Elowen-2 study Day 1, current LTE study Week 108)
研究者
研究点 (2)
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