EUCTR2021-005000-36-ES进行中（未招募）1 期
A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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. Subjects must be =18 years of age at Screening.
- •2. Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS = 4 for the most severely affected eye at Screening and Baseline.
- •3. Moderate-to-severe active TED with onset within 12 months prior to the Baseline visit and usually associated with one or more of the criteria described in the protocol.
- •4. Subjects must be euthyroid or, have subclinical hyperthyroidism.
- •5. Does not require immediate surgery, radiotherapy or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
- •6. Diabetic subjects must have HbA1c < 9.0%.
- •Please see the full details in the protocol.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- •2. Corneal decompensation unresponsive to medical management.
- •3. Decrease in CAS of = 2 points in the primary study eye between Screening and Baseline.
- •4. Decrease in proptosis of = 2 mm in the primary study eye between Screening and Baseline.
- •5. Previous orbital irradiation or surgery.
- •6. Prior IGF-1R inhibitor therapy for any condition.
- •7. Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to > 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.
- •8. Corticosteroid use (including topical) for conditions other than TED within 4 weeks prior to Screening.
- •9. Use of any other non-steroid immunosuppressive agent within 4 weeks prior to Screening.
- •10. Any previous treatment with anti-IL6 receptor, anti- CD20, (MS4A1) antibodies or monoclonal antibody for immunomodulation within the past 9 months prior to Screening.
- •11. Selenium and/or biotin use as a treatment for TED within 3 weeks prior to screening is disqualifying, not allowed and must not be restarted during the clinical trial or Follow-up period.
- •12. Identified pre-existing ophthalmic or other disease that in the judgement of the Investigator, would preclude study participation or complicate interpretation of study results.
- •13. Ocular surgery other than routine cataract surgery or subsequent YAG laser capsulotomy.
- •14. Biopsy-proven or clinically suspected inflammatory bowel disease (e.g., diarrhea with or without blood or rectal bleeding associated with abdominal pain or cramping/colic, urgency, tenesmus, or incontinence for more than 4 weeks without a confirmed alternative diagnosis OR endoscopic or radiologic evidence of enteritis/colitis without a confirmed alternative diagnosis).
- •15. History of QTcF prolongation; or QTcF prolongation at Screening.
- •16. Use of drugs causing QT interval prolongation within 14 days prior to Day 1 dosing.
- •17. Bleeding diathesis that in the judgment of the Investigator would preclude inclusion in the clinical trial.
- •18. Laboratory values as described in the protocol.
- •19. Malignant conditions being actively treated or treated in the past 12 months (with the exception of successfully treated basal cell of the skin). Recent (within 3 months of Screening) basal cell of the eyelid skin is excluded.
- •See the full list in the protocol.
研究者
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