An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 155
- 试验地点
- 52
- 主要终点
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
详细描述
Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Acquired from Horizon in 2024.
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to understand and provide written informed consent.
- •Must have completed the treatment period in the RECAST SLE study.
- •Women of childbearing potential must have a negative urine pregnancy test on Day
- •Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.
排除标准
- •Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
- •Participation in another clinical study with an IP during the RECAST SLE study period.
- •Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
- •Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit
- •Clinically significant active infection at Visit 1, in the opinion of the Investigator.
- •Pregnant or lactating females.
研究组 & 干预措施
Daxdilimab
Daxdilimab injections over a total of 48 weeks.
干预措施: Daxdilimab (Biological)
结局指标
主要结局
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to approximately 56 weeks
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.
Number of Participants Who Experienced Serious Adverse Events (SAEs)
时间窗: Up to approximately 56 weeks
An AE is considered "serious" if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * A congenital abnormality/birth defect * Important medical events judged to jeopardize the participant(s).
Number of Participants Who Experienced AEs of Special Interest (AESI)
时间窗: Up to approximately 56 weeks
An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were: * Hypersensitivity reaction, including anaphylaxis * Severe (Grade 3 or higher) viral infections/reactivations * Opportunistic infections * Malignancy (except non-melanoma skin cancer).
次要结局
- Serum Concentration of Daxdilimab(Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56)
- Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count(Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56)
- Number of Participants Expressing Anti-drug Antibodies (ADA)(Up to approximately 56 weeks)