CTIS2023-507196-22-00招募中1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD) - WN43194
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 173
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •1. Participants who are aged >=12 years at the time of signing Informed Consent Form and confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening, 2. Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening, 3. High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening, 4. Participants receiving either no ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening or receiving ongoing treatment with azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroids (OCS) or a combination of OCS and AZA or MMF prior to and at the time of screening, 5. No contraindications to rescue treatments and no contraindications to MRI, 6. For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
排除标准
- •1. Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum, 2. History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis, 3. Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study, 4. Intravenous immunoglobulins (IVIg) or subcutaneous immunoglobulins ( ScIg) within 4 weeks prior to screening, 5. Plasma exchange (PLEX) within 4 weeks prior to screening, 6. Systemic corticosteroids, AZA or MMF within 4 weeks prior to screening (if not continued as concomitant IST in the study)
研究者
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