CTIS2023-507350-33-00招募中1 期
An open-label study for participants who are non-responders at the end of treatment assessment on the VRDN-001-101 and VRDN-001-301 pivotal studies - VRDN-001-302
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 149
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Must be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity, Must have completed at least 5 infusions and assessments required to determine proptosis responder status as measured by exophthalmometer 3 weeks post the fifth infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies, Must have been a participant in either the VRDN-001- 101 or VRDN-001-301 studies and found to be nonresponder defined as either: a. A participant who did not achieve a = 2 mm reduction from baseline in proptosis (as measured by exophthalmometer) in the study eye at 3 weeks post the fifth infusion (i.e., Week 15) in either the VRDN-001-101 or VRDN-001-301 study OR b. A participant who achieved a = 2 mm reduction from baseline in proptosis (as measured by exophthalmometer) in the study eye but had a corresponding increase of = 2 mm from baseline in proptosis in the fellow eye at 3 weeks post the fifth infusion (i.e., Week 15) in either the VRDN-001-101 or VRDN-001-301 studies., Must not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason, Female TED participants must have a negative serum pregnancy test at Screening, Must agree to continue (if not a surgically sterile male) to use an acceptable method of contraception such as a condom and a second highly effective method of contraception as described in Section 4.4 from the Day 1 Visit up to and including 100 days after the last dose of study medication, Must be willing and able to comply with all the requirements of the protocol for the entire duration of the study
排除标准
- •Must not have received prior treatment with another anti-IGF-1R agent or any other investigational agent for TED, Must not have a compressive optic neuropathy of TED that is expected to require surgical decompression in the immediate future., Must not have corneal decompensation in the study eye unresponsive to medical management, Must not have used systemic corticosteroids for any condition, including TED, within 2 weeks prior to the first dose of study medication (topical is permitted), Must not have received other immunosuppressive agents, including rituximab, or tocilizumab, or other immunosuppressive agent within 8 weeks prior to the first dose of study medication, Must not have received any other therapy for TED within 8 weeks prior to the first dose of study medication (artificial tears are permitted), Must not have received an investigational agent for any condition (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001- 301 pivotal studies) within 8 weeks prior to the first dose of study medication, Must not have history of or baseline audiometry assessment of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss
研究者
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