NCT06989918招募中3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Active Moderate-to-Severe Thyroid Eye Disease.
Minghui Pharmaceutical (Hangzhou) Ltd1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年7月22日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Proptosis Responder Rate at Week 24
研究概览
简要总结
The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.
详细描述
The percentage of subjects with a reduction in proptosis of ≥2 mm in the study eye/target eye compared to baseline, without deterioration (≥2 mm) in the fellow eye.
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 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;
- •Clinical diagnosis of active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye/target eye at screening and baseline must be ≥3 points (7-point scale).
- •Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
- •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.
- •Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.
- •Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
- •Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.
- •Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops/ointments for TED within 4 weeks before the first dose; subjects who received periorbital/orbital steroid injections within 3 months before the first dose.
- •Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).
- •Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.
- •Previous treatment targeting IGF-1R.
- •Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and/or biotin is allowed.
- •Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.
- •Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.
- •Malignant condition in the past 5 years before signing the ICF (except successfully treated basal/squamous cell carcinoma of the skin).
- •Acute cardiovascular disease history or treatment within 6 months before the first dose.
- •Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
- •Pregnant or lactating women.
- •Drug or alcohol abuse during the screening period.
- •Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.
- •Biopsy-proven or clinically suspected inflammatory bowel disease.
- •Positive results for serum virology tests (defined as pos
- •Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.
- •Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.
- •Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.
研究组 & 干预措施
MHB018A
Experimental
6 subcutaneous injections of MHB018A, 450mg once every 4 weeks (q4w)
干预措施: MHB018A (Drug)
MHB018A Placebo
Placebo Comparator
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
干预措施: MHB018A placebo (Drug)
结局指标
主要结局
Proptosis Responder Rate at Week 24
时间窗: Week 24
The percentage of subjects with a reduction in proptosis of ≥2 mm in the study eye/target eye compared to baseline, without deterioration (≥2 mm) in the fellow eye.
次要结局
- Overall response rate(Week 24)
- Change in proptosis(Baseline, up to Week 24)
- Percentage of subjects with CAS of 0 or 1(Week 24)
- Change in CAS(Week 24)
- Diplopia response rate(Week 24)
- Change in Quality of Life (GO-QOL) Scores(Week 24)
- Pharmacokinetic Parameter Trough Concentration for MHB018A(Up to Week 24)
- Anti-MHB018A antibody (ADA) incidence(Up to Week 24 and at end-of-trial (EOT) visit)
研究者
研究点 (1)
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