A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Design Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Subcutaneous Injection in Chinese Patients With Active, Moderate to Severe Thyroid Eye Disease (TED)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Proptosis responder rates of the treatment groups and placebo group at Week 12
研究概览
简要总结
Primary Objective: To preliminarily evaluate the efficacy of the treatment regimen of HBM9161 680 mg administered subcutaneously weekly and sequentially every other week for 12 weeks in Chinese patients with active moderate to severe TED.
详细描述
This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, with the indication of TED. Subjects will be randomized to treatment group I, treatment group II, or placebo group. Subjects in treatment group 1 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 12 doses; Subjects in treatment group 2 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 6 doses, followed by HBM9161 680 mg subcutaneously once every two weeks (q2w) for 3 doses; Subjects in placebo group will receive placebo subcutaneously once weekly (qw) for 12 doses. After the 12-week dosing period, there will be a 5-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent form.
- •Male or female between the ages of 18 and 70 (including boundary values).
- •Active TED associated with a clinical diagnosis of Graves' disease or Hashimoto's thyroiditis with CAS ≥ 3 at the screening visit and baseline (both on a 7-item scale) in the eye with the most severe proptosis.
- •The active period of TED starts within 9 months prior to screening visit
- •Positive anti-TSHR antibody at screening visit.
- •Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.
排除标准
- •Other uncontrolled concurrent diseases
- •Serious TED requiring surgery or radiotherapy
- •Suffer from autoimmune diseases or ophthalmic conditions other than TED that, in the opinion of the investigator, would impact the assessment of the study drug
- •No significant laboratory abnormalities
研究组 & 干预措施
HBM9161 680 mg qw by q2w from week 13
Subcutaneous injection; HBM9161 680 mg qw from week 13
干预措施: HBM9161 680 mg qw by q2w from week 13 (Drug)
HBM9161 680 mg qw by q2w from week 7
Subcutaneous injection; HBM9161 680 mg qw by q2w from week 7
干预措施: HBM9161 680 mg qw by q2w from week 7 (Drug)
Placebo
Subcutaneous injection; Placebo
干预措施: Placebo (Drug)
Placebo qw by HBM9161 680mg qw from week 12
Placebo qw by HBM9161 680mg qw from week 12
干预措施: Placebo (Drug)
结局指标
主要结局
Proptosis responder rates of the treatment groups and placebo group at Week 12
时间窗: At week 12
Proptosis responder rates of the treatment groups and placebo group at Week 12
次要结局
- Diplopia response rate(At week 6, week 12, week 18 and week 24)
- Composite responder rate(At week 6, week 12, week 18 and week 24)
- The change from Baseline in proptosis measurement in the study eye(At week 6, week 12, week 18 and week 24)
- The changes in proptosis responder rate over time(From week 1 to week 24)
- The percentage of subjects with a CAS value of 0 or 1 in the study eye(At week 6, week 12, week 18 and week 24)
- The change from baseline in quantitative measurement of orbital structures by MRI, including exophthalmos values, fatty tissue thickness of inner side in eye balls, thickness of extraocular muscles. All the above parameters will be measured in millimeter(At week 12, week 24)
- The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score(At week 6, week 12, week 18 and week 24)