A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 209
- 试验地点
- 131
- 主要终点
- Population #1: - Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI) at Week XX
研究概览
简要总结
The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).
详细描述
The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo.
Acquired from Horizon in 2024.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
- •Have an ESSDAI score of >= 5 at screening (only for Population 1).
- •Have an ESSPRI score of >= 5 at screening (only for Population 2).
- •Have an ESSDAI score of < 5 at screening (only for Population 2).
- •Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both at screening.
排除标准
- •Concomitant system sclerosis.
- •Active malignancy or history of malignancy within the last 5 years with exception of in situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR cutaneous basal cell carcinoma following presumed curative therapy.
- •Individuals who are pregnant or lactating or planning to become pregnant during the study.
- •Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or HIV infection.
- •Individuals with history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. Individuals with a prior history of ophthalmic herpes zoster will be excluded.
- •Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
- •Last administration of experimental biologic or oral agents < 6 months or 5 half-lives, whichever is longer, before screening.
- •Individuals who have had previous treatment with any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, or ofatumumab) within 12 months or other B cell targeting therapy (eg, belimumab) or anti-type I IFN pathway therapy (eg, anifrolumab) < 6 months before randomization.
结局指标
主要结局
Population #1: - Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI) at Week XX
Population #1: - Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI) at Week XX
"Population #2: - Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Patient Reported Index (ESSPRI) at Week XX"
"Population #2: - Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Patient Reported Index (ESSPRI) at Week XX"
次要结局
- Population #2: - Change from baseline in PROMIS-Fatigue SF-10a at Week XX
- Population #1 and #2: - PK of HZN-1116
- Population #1: - Change from baseline in ESSDAI at Week XX
- Population #1: - Proportion of participants achieving ESSDAI[5] response at the Week XX and XX time points without premature discontinuation from treatment and without receiving rescue or potentially confounding therapy
- Population #1: - Change from baseline in ESSPRI- and Diary for Assessing Sjögren’s Patient Reported Index (DASPRI)-pain, -fatigue, and -dryness domains at the Week XX and XX time points.
- Population #1: - Change from baseline in tender joint count (TJC) and swollen joint count (SJC) at the Week XX and XX time points
- Population #1: - Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS) at the Week XX and XX time points
- Population #1: - Change from baseline in PROMIS-Fatigue SF-10a at Week XX and Week XX
- Population #2: - Change from baseline in DASPRI at Week XX
- Population #2: - Proportion of participants achieving ESSPRI[1.5] response without premature discontinuation from treatment and without receiving rescue or potentially confounding therapy at Week XX
- Population #2: - Change from baseline in ESSPRI -pain, -fatigue, and -dryness domains at Week XX
- Population #2: - Change from baseline in SF-36 PCS and MCS at Week XX
- Population #1 and #2: - Proportion of participants who develop anti-drug antibodies (ADA) over time
研究者
Amgen Europe B.V Contact point for union
Scientific
Horizon Therapeutics Ireland Designated Activity Company