2024-519292-26-00招募中2 期
A Phase 2, Randomised, Double-masked, Placebo-controlled, Parallel-group, Multi-centre Study to Evaluate K1-70 in Patients with Active Thyroid Eye Disease in Europe
Av7 Limited5 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Exophthalmos improvement rate at Week 24* *The proportion (%) of subjects who achieve at least a 2-mm decrease in exophthalmos of the study eye from baseline and have no worsening in exophthalmos (defined as an increase of at least 2 mm) in the fellow eye.
研究概览
简要总结
To compare the exophthalmos improvement rate achieved with K1-70 once every 6 weeks (q6W) for 24 weeks with that achieved with placebo in subjects with Graves’ disease and active thyroid eye disease.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Open Label extension study
- 盲法
- None
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
- •Subjects must satisfy all the following criteria to be enrolled in the study
- •Is a male or female subject aged 18 to 75 years of age inclusive, at the time of signing and dating the informed consent form (ICF).
- •Must sign and date the ICF indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •Have clinically confirmed Graves’ disease with active thyroid eye disease at screening and baseline, with the study eye satisfying criterion a) or b). Criterion a) will be used if magnetic resonance imaging (MRI) is available and criterion b) will be used if not. a) Have inflammatory hypertrophy of the extraocular muscles as shown by MRI according to the criteria of the 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. b) The Clinical activity score (CAS) is at least
- •Has exophthalmos of ≥18 mm in the study eye, or if <18mm in the study eye there is at least 3 mm greater proptosis in the study eye compared to the fellow eye.
- •Have any symptoms of eyelid retraction, soft-tissue findings, or diplopia as defined in the criteria for moderate to severe eye disease in the 2021 EUGOGO clinical practice guidelines for the medical management of Graves' orbitopathy.
- •Has self-reported symptoms of active thyroid eye disease within the 12 months prior to Screening.
- •Has Graves' disease whose underlying condition is controlled and has normal thyroid function at the time of screening or has mild hypothyroidism or hyperthyroidism.Every effort should be made to maintain thyroid function throughout the study”.
- •Is a female of childbearing potential or male with a female partner of childbearing potential who consents to use acceptable contraceptive methods as defined in the protocol. Additional inclusion criteria are outlined in the study protocol.
排除标准
- •Individuals who meet any of the following criteria will be excluded from the study :
- •Has dysthyroid optic neuropathy and/or very severe eye disease (with the risk of blindness) that features ulceration, perforation or necrosis of the cornea and requires urgent therapeutic intervention.
- •Whose CAS decreased by 2 or more points in the study eye from screening to baseline
- •Whose exophthalmos decreased by 2 mm or more in the study eye from screening to baseline.
- •Has a history of orbital radiotherapy or surgery for thyroid eye disease.
- •Has received a systemic corticosteroid (IV or orally), intraorbital corticosteroid injection, or ophthalmic corticosteroid drug for treating thyroid eye disease or another medical condition within the 3 weeks prior to providing informed consent. None of these corticosteroid treatments may be started during the study period. This excludes corticosteroids that are locally administered to an area not near the orbits (e.g., topical corticosteroids, intraarticular corticosteroid injections, and inhaled corticosteroids) and corticosteroids for treating infusion-related reactions
- •Has had any previous systemic treatment with rituximab (Rituxan®) within the 12 months prior to the start of study drug administration, tocilizumab (Actemra®) within the 6 months prior to the start of study drug administration, or any systemic non-steroid immunosuppressive agent within the 3 months prior to the start of study drug administration.
- •Have received treatment around the eyes with botulinum toxin within the 3 months prior to the start of study drug administration.
- •8.Has a pre-existing ophthalmic disease that, in the opinion of the investigator, would preclude study participation or complicate interpretation of the study results Additional exclusion criteria are outlined in the study protocol.
结局指标
主要结局
Exophthalmos improvement rate at Week 24* *The proportion (%) of subjects who achieve at least a 2-mm decrease in exophthalmos of the study eye from baseline and have no worsening in exophthalmos (defined as an increase of at least 2 mm) in the fellow eye.
Exophthalmos improvement rate at Week 24* *The proportion (%) of subjects who achieve at least a 2-mm decrease in exophthalmos of the study eye from baseline and have no worsening in exophthalmos (defined as an increase of at least 2 mm) in the fellow eye.
次要结局
- Change from baseline in the ratio of signal intensity in the extraocular muscles shown by MRI. Change from baseline in the GO-QOL score Change from baseline in the CAS. Change from baseline in exophthalmos measurement . Change from baseline in diplopia grade (Bahn-Gorman scale) (diplopia improvement rate) Change from baseline in retrobulbar volume shown by MRI
- Safety, determined by: a) AEs b) Vital sign measurements c) 12-lead ECG measurements d) Laboratory test results e) Physical examination results f) Eye examination results Changes in levels of TSH, thyroid hormones (FT4 and FT3), TSH receptor autoantibodies and stimulating TSH receptor autoantibodies Change over time in blood concentrations of K1-70 Change over time in blood concentrations of Anti-drug antibodies
研究者
Dr Shu Chen
Scientific
Av7 Limited
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Visual Outcomes and Quality of Life After Vivity EDOF IOL Implantation in Early-Stage KeratoconusCataractNCT07338708Azienda Ospedaliera Universitaria Integrata Verona10
已完成
2 期
MK-7684A (new drug co-formulation of pembrolizumab with an anti-TIGIT) plus docetaxel works to help stop or slow down the growth of your non-small cell lung cancer (NSCLC) compared to docetaxel alone2022-501252-28-00Merck Sharp & Dohme LLC150
招募中
3 期
Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study of Efficacy and Safety of ESK-001 for Moderate to Severe Plaque Psoriasis (ONWARD1)2023-507193-40-00Alumis Inc.389
招募中
不适用
iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma TreatmentNCT07325552Medical University of Bialystok100
招募中
1 期
PVEK Corneal Implant For Treatment of Corneal EdemaNCT07325097Precise Bio15