EUCTR2020-005999-36-ES进行中（未招募）1 期
A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab - TEPEZZA (teprotumumab-trbw) Post-Marketing Requirement
Horizon Therapeutics U.S.A., Inc.0 个研究点目标入组 300 人开始时间: 2021年12月17日最近更新:
适应症
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
- 300
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
- •Eligible patients must meet/provide all of the following criteria:
- •1. Written informed consent.
- •2. Male or female between the ages of 18 and 80 years, inclusive, at Screening.
- •3. Initial diagnosis of TED within 7 years prior to Screening.
- •4. Proptosis =3 mm from baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis >3 mm above normal for race and gender.
- •5. Patients must be euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels <50% above or below the normal limits) at Screening. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid state for the duration of the trial.
- •6. Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial.
- •7. Diabetic patients must have HbA1c =8.0% at Screening.
- •8. Patients with a history of IBD (ulcerative colitis or Crohn’s disease) must be in clinical remission for at least 3 months, with no history of bowel surgery within 6 months prior to Screening and no planned surgery during the trial. Concomitant stable therapies for IBD without modifications in the 3 months prior to Screening are allowed.
- •9. Women of childbearing potential (including those with an onset of menopause <2 years prior to Screening, non-therapy-induced amenorrhea for <12 months prior to Screening or not surgically sterile [absence of ovaries and/or uterus]) must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (i.e., prior to each dose and throughout the patient's participation in the Follow-up Period); patients who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Baseline and continue for 180 days after the last dose of teprotumumab. Highly effective contraceptive methods (with a failure rate <1% per year), when used consistently and correctly, include implants, injectables, tubal ligation, combination oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner.
- •10. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- •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 252
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •Patients will be ineligible for trial participation if they meet any of the following criteria:
- •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 proptosis of =2 mm in the study eye between Screening and Baseline.
- •4. Prior orbital irradiation, orbital decompression or strabismus surgery.
- •5. Planned eyelid surgery during the course of the trial
- •6. Alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal or estimated glomerular filtration rate =30 mL/min/1.73m2 at Screening.
- •7. Use of any steroid (intravenous, oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids, as well as steroids used to treat infusion reactions.
- •8. Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of teprotumumab. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of teprotumumab.
- •9. Any previous treatment with teprotumumab, including previous enrollment in this trial or participation in a prior teprotumumab trial.
- •10. Treatment with any monoclonal antibody within 3 months prior to Screening.
- •11. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude trial participation or complicate interpretation of trial results.
- •12. Use of an investigational agent for any condition within 60 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial.
- •13. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
- •14. Pregnant or lactating women.
- •15. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the patient.
- •16. Known hypersensitivity to any of the components of teprotumumab or prior hypersensitivity reactions to monoclonal antibodies.
- •17. Human immunodeficiency virus, untreated or positive viral load for hepatitis C or hepatitis B infections.
- •18. Any other condition that, in the opinion of the Investigator, would preclude inclusion in the trial.
- •19. After 150 patients with a CAS <3 at Baseline have been randomized, an additional exclusion criterion will apply: CAS <3 at Baseline.
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