2023-506046-24-00已完成2 期
A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis
Amgen Inc.65 个研究点 分布在 14 个国家目标入组 70 人开始时间: 2023年10月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 65
- 主要终点
- Treatment-emergent adverse events
研究概览
简要总结
To evaluate the long-term safety and tolerability of efavaleukin alfa in subjects with moderate to severe ulcerative colitis (UC)
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
- •Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •subject has completed the week 52 endoscopy in the phase 2 parent dose-finding study (20170104) for any reason
排除标准
- •Permenant discontinuation of investigational product during the 52-week phase 2 dose finding study (20170104) for any reason
- •Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
- •Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed during study and for an additional 6 weeks after the last dose of investigational product
- •Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product
- •Female subjects of reproductive potential must agree not to donate eggs during the study and for 6 weeks after receiving the last dose of investigational product
- •Subject has known sensitivity to any of the products to be administered during dosing with the exception of subjects who exhibited sensitivity in Study 20170104 but did not result in treatment discontinuation
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required sutdy procedures (e.g, clinical outcome assessments) to the best of the subject and invesitgator's knowledge
- •Subject has a history or evidence of any other clinically significant disorder (including laboratoy abnormalities), condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted would pose a risk to subject safety, or interfere with the study evaluation, procedurs, or completion
- •adenoma and dysplasia exclusion criteria: -any current sporadic adenoma without dysplasia (adenomatous polyps occuring proximal to known areas of colitis) that has not been removed -dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, and dysplasia-associated lesions or masses will be managed as follows: any history or current evidence of high-grade dysplasia, any history or current evidence of dysplasia occurring in flat mucosa (this includes histopathology reporting indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia), any history or current evidence of a non-adenoma like dysplasia associated lesions or masses, with or without evidence of dysplasia, any current sporadic adenoma containing dysplasia or any current adenoma-like dysplasia-associated lesions or masses that has not been removed
- •Any malignancy diagnosed during Study 20170104, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
- •Active infection (including chronic, acute, recurrent, opportunistic infections) at the time of eligibility evaluation requiring intravenous (IV) anti-infectives or hospitalization (infections requiring oral and/or topical anti-infective[s] for >7 days may be allowed in consulation with the Amgen physician)
- •Required systemic corticosteroid use for any indication other than UC. The only exception is corticosteroids used for the treatment of adrenal insufficiency are allowed
- •Plan to receive a live (attenuated) vaccine during the treatment period and up to 6 weeks after the last dose of investigational product in the LTE study
研究组 & 干预措施
Group with
Test
结局指标
主要结局
Treatment-emergent adverse events
Treatment-emergent adverse events
次要结局
- Clinical response at week 52 and 104
- Clinical remission at week 52 and 104
- Durable clinical remission at week 52 and 104
- Endoscopic remission at week 52 and 104
- Histologic remission at week 52 and 104
- Corticosteroid-free remission at week 52 and 104 in subjects receiving corticosteroids at randomization of the phase 2 parent study (Study 20170104)
- Combined endoscopic and histologic remission at week 52 and 104
- Symptomatic remission at week 52 and 104
- Change from baseline of Study 20170104 in histological score (Geboes) at week 52 and 104
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (65)
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