NCT07265258招募中4 期
A Multicenter, Randomized, Open-Label, Active-Controlled Phase IV Clinical Study to Evaluate the Efficacy and Safety of Teprotumumab N01 in the Treatment of Active Thyroid Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- The proptosis responder rate of the study eye
研究概览
简要总结
This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Male or female subject between the ages of 18 and 80 years at screening.
- •Weight between 45 kg and 100 kg.
- •Moderate-to-severe active TED:
- •CAS ≥ 3 in the study eye at screening and baseline;
- •Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia;
- •≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;
- •Exophthalmos ≥ 16 mm in the study eye at baseline.
- •Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.
排除标准
- •Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
- •The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;
- •Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
- •Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
- •Scheduled orbital radiotherapy at any time before baseline or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;
- •Participants with poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) deviating from the normal reference range of the local laboratory by more than 50% at screening;
- •Any other pre-existing disease, metabolic disorder, or physical examination or clinical laboratory abnormality that leads to a reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, affects the interpretation of study results, or places the participant at high risk of treatment complications;
- •History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB at 0.5, 1, 2, and 4 kHz, or a bone conduction hearing threshold of ≥ 40 dB at any frequency);
- •Poorly controlled diabetes mellitus (defined as glycosylated hemoglobin ≥ 8.0% at screening);
- •Cumulative dose of glucocorticoids used to treat TED ≥ 1 g methylprednisolone equivalents at any time before baseline;
- •Oral or intravenous glucocorticoids within 30 days prior to screening;
- •Peribulbar/periorbital injection of glucocorticoids within 90 days prior to screening;
- •Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;
- •Use of glucocorticoid eye drops/ointments or use of non-steroidal immunosuppressant eye drops within 30 days prior to screening;
- •Received TEPEZZA or Teprotumumab N01 Injection at any time before screening;
- •Received CD20 antibody or interleukin-6 receptor (IL-6R) antibody at any time before screening;
- •Have received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn, and TSHR) at any time before screening;
- •Use of any other monoclonal antibody within 90 days prior to screening;
- •Female participants in pregnancy or lactation.
研究组 & 干预措施
Teprotumumab N01 group
Experimental
干预措施: Teprotumumab N01 (Biological)
Intravenous glucocorticoid (IVGC) group
Active Comparator
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
The proptosis responder rate of the study eye
时间窗: Week15
The proptosis response rate of the study eye was defined as the percentage of participants with a ≥ 2 mm reduction in proptosis of the study eye from baseline and without a ≥ 2 mm increase in proptosis of the fellow eye. Proptosis assessment: protrusion of the eye from the orbital rim as measured using a Hertel exophthalmometer.
次要结局
- Number, incidence, severity, and correlation with the investigational drug or treatment of all ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE).(After receiving Teprotumumab N01 or IVGC treatment for 48 weeks)
- Change from baseline in proptosis of the study eye(Weeks 15, 24 and 48)
- The overall response rate of the study eye(Weeks 15, 24 and 48)
- The proptosis response rate of the study eye(Weeks 24 and 48)
- Change from baseline in proptosis of the study eye on MRI imaging(Week15)
- The composite effective rate of the study eye(Weeks 15, 24 and 48)
- Change from baseline in CAS of the study eye(Weeks 15, 24 and 48)
- Rate of CAS of 0 or 1 in the study eye(Weeks 15, 24 and 48)
- The diplopia response rate(Weeks 15, 24 and 48)
- The diplopia resolution rate(Weeks 15, 24 and 48)
- Change from baseline in proptosis of the fellow eye(Weeks 15, 24 and 48)
- Change from baseline of the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire score(Weeks 15, 24 and 48)
- The safety and tolerability of Teprotumumab N01 and IVGC(After receiving Teprotumumab N01 or IVGC treatment for 48 weeks)
研究者
研究点 (1)
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