2023-508290-81-00进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease.
Horizon Therapeutics Ireland Designated Activity Company15 个研究点 分布在 6 个国家目标入组 90 人开始时间: 2024年3月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 15
- 主要终点
- Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and AC-determined IgG4 RD flare within the 52-week RCP. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.
研究概览
简要总结
To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •1.Male or female adults who have reached the age of consent in the applicable region (eg, ≥18 years in the US)
- •Clinical diagnosis of IgG4-RD.
- •Fulfillment of the 2019 ACR/EULAR classification criteria.
- •Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
- •IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD. One organ must meet the requirements for the ACR/EULAR classification criteria; the second organ is as defined by the investigator
- •Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide (where spermicide is available) from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highlyeffective method of contraception.
排除标准
- •History of solid organ or cell-based transplantation or known immunodeficiency disorder .
- •Active malignancy or history of malignancy that was active within the last 10 years (some specific situations for cervical, skin, prostate or thyroid cancer are acceptable).
- •Receipt of any biologic B cell-depleting therapy or non-depleting Bcell- directed therapy in prior 6 months.
- •Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks
- •Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
- •Live vaccine or therapeutic agent in prior 2 weeks
- •Glomerular filtration rate < 30 mL/min/1.73 m2
结局指标
主要结局
Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and AC-determined IgG4 RD flare within the 52-week RCP. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.
Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and AC-determined IgG4 RD flare within the 52-week RCP. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.
次要结局
- 3. The proportion of subjects achieving flare-free, corticosteroid-free complete remission at Week 52, defined as the lack of evident disease activity at Week 52, no AC-determined flare during the RCP, and no corticosteroid treatment for flare or disease control except the required 8-week GC taper.
- 4. Time to initiation of first treatment (medication or procedure) for new or worsening disease activity by the Investigator within the RCP, regardless of AC determination of flare.
- 5. Annualized flare rate for AC-determined flares, whether or not treated, during the RCP.
- 6. Glucocorticoid use, calculated as the cumulative GC dose taken for the purpose of IgG4 RD disease control during the RCP.
- 7. Incidence of treatment emergent adverse events (TEAEs), serious TESAEs, and TEAEs of special interest (AESIs) during the 52-week RCP and during the OLP.
- 8. The incidence of ADAs directed against inebilizumab during the RCP.
- 1. Annualized flare rate for treated and AC-determined flares during the RCP.
- 2. The proportion of subjects achieving flare-free, treatment-free complete remission at Week 52, defined as the lack of evident disease activity at Week 52, no AC-determined flare during the RCP, and no treatment for flare or disease control except the required 8-week GC taper.
研究者
Sue Cheng
Scientific
Horizon Therapeutics Ireland Designated Activity Company
研究点 (15)
Loading locations...
相似试验
招募中
3 期
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)2023-504022-19-01AstraZeneca AB84
招募中
2 期
Immunoprevention for High-risk Lung LesionsNCT07284485Robert Samstein59
招募中
2 期
GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 AstrocytomaNCT07301268Mayo Clinic36
招募中
3 期
Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma2022-501966-23-00Merck Sharp & Dohme LLC530
招募中
3 期
Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjögren’s syndrome2024-511068-10-00Novartis Pharma AG150