EUCTR2020-001611-24-DE进行中（未招募）1 期
A two-year multi-center Phase 3 study to investigate the efficacy and safety of secukinumab in adult patients with active, moderate to severe thyroid eye disease (ORBIT), with a randomized, parallel-group, double-blind, placebo-controlled, 16-week treatment period, and a follow-up/retreatment period - ORBIT
ovartis Pharma GmbH0 个研究点目标入组 70 人开始时间: 2020年10月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- •2. Male or non-pregnant, non-lactating female patients = 18 years of age.
- •3. Clinical diagnosis of active, moderate-to-severe TED (not sight-threatening) in the study eye at Baseline associated with 2 or more of the following:
- •- Lid retraction = 2 mm
- •- Moderate or severe soft tissue involvement
- •- Exophthalmos = 3 mm above normal
- •- Inconstant or constant diplopia
- •4. Onset of TED symptoms fewer than 12 months prior to Baseline.
- •5. CAS = 4 (on a 7-point scale, with a score of = 3 indicating active TED) in the more severely affected (study) eye at Screening and Baseline. Note: Proptosis is the primary qualifier for selection of the study eye. In case both eyes show a similar degree of proptosis, other inflammatory signs and symptoms (CAS) should be taken into account by the investigator for the selection of the study eye.
- •6. Peripheral euthyroidism or mild hypo-/hyperthyroidism defined as free T3 (fT3) and free T4 (fT4) < 30% above/below normal limits at Screening. Every effort should be made to correct the mild hypo-/hyperthyroidism promptly and to maintain the euthyroid state until the end of this study.
- •7. Orbital MRI assessment available confirming the diagnosis of TED for patients initially presenting with hypo- or euthyroidism (without treatment for hyperthyroidism) before or at the time of TED diagnosis (to rule out other potential causes of orbital signs and symptoms).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Improvement in CAS of = 2 points and/or improvement in proptosis of = 2 mm in the study eye between Screening and Baseline.
- •2. Signs of sight-threatening TED defined by optic neuropathy or severe corneal injury.
- •3. Patients, in the opinion of the investigator, requiring immediate or urgent medical treatment with glucocorticoids for TED.
- •4. Patients requiring immediate surgical ophthalmological intervention or planning corrective surgery/irradiation during the course of the study.
- •5. Decreased best corrected visual acuity (BCVA) as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect within the last 6 months.
- •6. Any other ophthalmic and/or orbital disease or condition that might interfere with the assessment of TED.
- •7. Previous orbital radiotherapy.
- •8. Previous ophthalmological/orbital surgery for TED (e.g. orbital decompression).
- •9. Previous use of biological agents for the treatment of TED.
- •10. Previous use of systemic, non-biologic, immunomodulatory agents for the treatment of TED (e.g., mycophenolate or cyclosporine).
- •11. Previous exposure to secukinumab or other biologic drugs directly targeting IL-17A or the IL-17 receptor (e.g., ixekizumab, brodalumab).
- •12. Previous treatment with rituximab, tocilizumab or teprotumumab.
- •13. Previous use of systemic corticosteroids for the treatment of TED, except for oral corticosteroids with a cumulative dose equivalent to < 1 g oral prednisone/prednisolone if the corticosteroid was discontinued at least 4 weeks prior to Baseline.
- •14. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19).
- •15. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
- •16. Previous or ongoing use of prohibited treatments. Respective washout periods have to be adhered to.
- •17. History of hypersensitivity to any of the study drug constituents.
- •Other protocol-defined exclusion criteria may apply
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