NCT06747949招募中3 期
A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 844
- 试验地点
- 278
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •Participant has provided informed consent before initiation of any study specific activities/procedures.
- •Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
- •Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
- •Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.
- •Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration.
- •Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
- •Individuals who plan to receive live (attenuated) vaccine during the LTE study.
- •Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
- •Female participants who are pregnant or lactating or planning to become pregnant during the study.
- •Participant has known sensitivity to any of the products or components to be administered during dosing.
- •Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- •History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.
研究组 & 干预措施
Dazodalibep
Experimental
Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks.
干预措施: Dazodalibep (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 152 weeks
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
次要结局
- Number of Participants with Anti-drug Antibodies (ADAs) During the Study(Up to 132 weeks)
- Plasma Concentration of Dazodalibep(Up to 132 weeks)
研究者
研究点 (278)
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