NCT07262476
尚未招募
3 期
A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease
Minghui Pharmaceutical (Hangzhou) Ltd1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2026年1月1日最近更新:
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Minghui Pharmaceutical (Hangzhou) Ltd
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Proptosis Responder Rate at Week 24
概览
简要总结
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
详细描述
The primary objective of this study is to evaluate the improvement in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) following treatment with MHB018A Injection in subjects with active or chronic TED who previously received placebo in either the MHB018A-P-301 or MHB018A-P-302 studies, and the safety and tolerability of MHB018A Injection in TED subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participating in the study and signing the informed consent form;
- •Aged 18-75 years (inclusive), of any gender;
- •Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the previous study when enrolled in this OLE study (does not apply to subjects who meet the relapse criteria during the safety follow-up period).
- •Proptosis non-responder at Week 24 visit in the double-blind treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a \<2 mm reduction from baseline in the study eye, or a ≥2 mm reduction in the study eye accompanied by a ≥2 mm worsening from baseline in proptosis of the fellow eye), and/or who meet the retreatment criteria for relapse during the safety follow-up period.
- •Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
- •Diabetic subjects must have well-controlled stable disease.
- •Sufficient bone marrow and organ function.
- •Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.
- •Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.
排除标准
- •Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.
- •Corneal decompensation unresponsive to medical management.
- •Free thyroxine (FT4) and free triiodothyronine (FT3) levels \<50% above or below the normal reference range at screening.
- •Received any treatment for TED, intravenous corticosteroids, immunosuppressive agents, investigational drug from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.
- •Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.
- •Acute cardiovascular disease history or treatment within 6 months before the first dose from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.
- •Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
- •Pregnant or lactating women.
- •Tinnitus or other hearing impairment.
- •Poor compliance or severe systemic disease history or other reasons that make the subject unsuitable for participation in this clinical study.
研究组 & 干预措施
MHB018A Injection
Experimental
Subcutaneous injections of MHB018A injection, 450mg once every 4 weeks (q4w).
干预措施: MHB018A injection (Drug)
结局指标
主要结局
Proptosis Responder Rate at Week 24
时间窗: Week 24
The proptosis response rate at Week 24 in the study eye for subjects with active or chronic TED who received MHB018A placebo in either the MHB018A-P-301 or MHB018A-P-302 studies: the proportion of subjects achieving a reduction of ≥2 mm in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) in the study eye, without deterioration in the other eye (defined as an increase in proptosis of ≥2 mm).
次要结局
- TED relapse rate(From baseline up to Week 24)
- TED relapse time(Up to Week 24 and at end-of-trial (EOT) visit)
- Pharmacokinetic Parameter Trough Concentration for MHB018A(Up tp Week 24)
- Overall response rate(Week 24)
- Percentage of subjects with CAS of 0 or 1(Week 24)
- Change in proptosis(Baseline, up to Week 24)
- Change in CAS(Week 24)
- Incidence of Adverse Events (AEs) During Treatment(Up to Week 24 and at end-of-trial (EOT) visit)
- Diplopia response rate(Week 24)
- Change in Quality of Life (GO-QOL) Scores(Up tp Week 24)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
MHB018A Treatment in Patients With Chronic Thyroid Eye DiseaseNCT07257185Minghui Pharmaceutical (Hangzhou) Ltd150
招募中
1 期
A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor PatientsNCT07260305Kangabio AUSTRALIA LTD PTY57
招募中
不适用
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D MutationNCT07259590Genfleet Therapeutics (Shanghai) Inc.126
尚未招募
不适用
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + DinutuximabNCT07261241New Approaches to Neuroblastoma Therapy Consortium118
招募中
3 期
A study to learn more about how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced non-small cell lung cancer (NSCLC) with mutations of the human epidermal growth factor receptor 2 (HER2)2024-511319-91-00Bayer AG145