A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 155
- 试验地点
- 55
- 主要终点
- For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)
研究概览
简要总结
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
详细描述
The study consists of the following periods:
Screening period (up to 4 weeks):
Following the signing of the informed consent, participants will be assessed for eligibility during this period of up to 4 weeks.
Treatment Period 1 + Treatment Period 2, (Week 0 to Week 24):
After completion of the screening period, eligible participants will be randomized at the Baseline visit (Week 0) to one of the 2 treatment sequences (treatment switch at Week 12) in a ratio of 1:1 described below:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained before any assessment is performed.
- •Male and female patients aged 18 years to 70 years (inclusive).
- •Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m
- •BMI = Body weight (kg) / [Height (m)]2 at screening.
- •Diagnosed with RA, SjD and/or SLE as determined by the investigator.
- •Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
- •Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment.
- •Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.
排除标准
- •Use of prohibited therapies.
- •Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection.
- •Plans for administration of live vaccines during the study period.
- •Uncontrolled co-existing serious disease.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug.
- •US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)
For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)
次要结局
- For each cohort, ianalumab PK parameters will be determined: Tmax and Ctrough
- Adverse events, laboratory evaluations, vital signs, ECG parameters
- Anti-ianalumab antibodies (ADA); incidence of ADA positive participants
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG