2025-523757-33-00招募中2 期
A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability via Autoinjector Device versus Syringe in Patients with Multiple Sclerosis
Tg Therapeutics Inc.10 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Incidence of treatment emergent adverse events (TEAE)
研究概览
简要总结
Part 1: To evaluate the PK and safety of ublituximab SC at different sites of administration Part 2: To assess the relative bioavailability of ublituximab SC administered with prefilled pen versus syringe
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Diagnosis of RMS (2017 Revised McDonald criteria, see Section 17.1) and documented evidence of either a. ≥ 2 relapses in prior 2 years or 1 relapse in the one year prior to screening, and/or b. ≥1 Gd enhancing lesion in the year prior to screening
- •Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening
- •Neurologically stable for > 30 days prior to Screening and Day 1
- •Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab
排除标准
- •Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS)
- •History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML)
- •Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration (Day 1)
- •Any severe or uncontrolled medical condition that could affect the participant’s ability to participate
- •Females who are pregnant or nursing
- •Any malignancies, excluding definitely treated basal cell and in situ squamous cell carcinomas
- •Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol
- •Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn’s disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.)
- •Participants with significantly impaired organ function as evidenced by the laboratory-based eligibility criteria
- •Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening
- •History of life-threatening injection/infusion related reaction (IRR), hypersensitivity, or anaphylactic reaction with any component of the ublituximab solution, protocol required pre-treatment medications, or protocol required procedure medications (including magnetic resonance imaging [MRI] contrast)
- •Active infection or known history of clinically significant recurrent infection
- •History of serious opportunistic or atypical infections, including human immunodeficiency virus (HIV) and tuberculosis
- •History of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb)
- •Chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
研究组 & 干预措施
Ublituximab
Test
干预措施: Ublituximab (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAE)
Incidence of treatment emergent adverse events (TEAE)
次要结局
- Incidence of TEAE
研究者
Clinical Support Team
Scientific
Tg Therapeutics Inc.
研究点 (10)
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