VRDN-003-302: A phase 3, randomized, double-masked, placebo-controlled, efficacy, safety, and tolerability study of VRDN-003 in participants with chronic thyroid eye disease (TED)
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 24
- 主要终点
- The primary study endpoint will assess the percentage of participants who have a response called Overall Responder Rate at Week 24. An Overall Responder is a participant who achieves a ≥ 2 mm reduction in eye bulging AND shows no worsening in Clinical Activity Score or CAS (that is an estimate of disease severity/symptoms) at Week 24 versus measurements before the first dose.
概览
简要总结
To determine if VRDN-003 is efficacious (meaning if VRDN-003 affects the signs and symptoms of TED), safe and tolerable (meaning if the body reacts acceptably to VRDN-003) when administered as a series of subcutaneous/SC (injection into layer of fat between skin and muscle) injections given every 4 weeks or every 8 weeks compared to placebo (a substance with no active drug ingredients) in participants with chronic TED
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
- 是
入选标准
- •Adult males or females, ≥18 to ≤75 years of age who have a clinical diagnosis of TED with any value on the CAS scale (0-7)
- •Must have moderate to severe chronic TED with eye bulging value in the study eye before the first dose as defined in the protocol
- •Have experienced eye-related signs or symptoms that began more than 15 months before the first study visit
- •Must agree to use highly effective contraception as specified in the protocol
- •Female participants must have a negative pregnancy test at first study visit
排除标准
- •Received prior treatment with another anti-IGF-1R therapy
- •Received corticosteroids (drugs that reduce inflammation in the body) for any condition, including TED, within 2 weeks prior to first dose.
- •Received other immunosuppressive drugs (drugs that dampen the body’s immune response) or any other therapy for TED within 12 weeks prior to first dose or another investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
- •Have had previous orbital irradiation or decompression surgery for TED or a pre-existing eye condition which in the study doctor’s opinion, would interfere with interpretation of study results
- •Have abnormal hearing test before first dose. History of ear conditions considered significant by study doctor
- •Have inflammatory bowel disease (conditions that involve inflammation of the gastrointestinal [GI] tract)
- •Female participants who are pregnant or breastfeeding
结局指标
主要结局
The primary study endpoint will assess the percentage of participants who have a response called Overall Responder Rate at Week 24. An Overall Responder is a participant who achieves a ≥ 2 mm reduction in eye bulging AND shows no worsening in Clinical Activity Score or CAS (that is an estimate of disease severity/symptoms) at Week 24 versus measurements before the first dose.
The primary study endpoint will assess the percentage of participants who have a response called Overall Responder Rate at Week 24. An Overall Responder is a participant who achieves a ≥ 2 mm reduction in eye bulging AND shows no worsening in Clinical Activity Score or CAS (that is an estimate of disease severity/symptoms) at Week 24 versus measurements before the first dose.
次要结局
- The secondary endpoints will assess changes in eye bulging versus measurements before the first dose, and percent of participants who achieve the required reduction in eye bulging, disease severity and symptoms, and reduction and resolution of double vision at Week 24.
- Safety Endpoint: the study will also evaluate safety events (side effects), the effects of VRDN-003 on the body and vice-versa throughout the study.
研究者
Chief Medical Officer
Scientific
Viridian Therapeutics S.à.r.l.