EUCTR2018-004676-35-ES进行中（未招募）1 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients with Active, Moderate to Severe Graves’ Ophthalmopathy - RVT-1401-2001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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. Male or female = 18 years of age.
- •2. A female participant is eligible to participate if she is of:
- •a. Non-childbearing potential defined as pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy; hysteroscopic sterilization, or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) in the post-menopausal range is confirmatory].
- •b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 6.6.1 for an appropriate period of time (as determined by the product label or Principal Investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female participants must agree to use contraception until 90 days after the last dose of study treatment.
- •3. Male participants must agree to use one of the contraception methods listed in Section 6.6.1. This criterion must be followed from the time of the first dose of study treatment until 90 days after the last dose of study treatment.
- •4. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active, moderate to severe GO with a CAS = 4 for the most severely affected eye at Screening and Baseline.
- •5. Onset of active GO within 9 months of screening.
- •6. Documented evidence at Screening of detectable anti-TSHR-Ab.
- •7. Participant does not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for GO during the course of the study.
- •8. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction = 2 mm, moderate or severe soft tissue involvement, proptosis = 3 mm above normal for race and gender (see study specific manual), and/or inconstant or constant diplopia.
- •9. Stable medical regimen; unlikely to require adjustment of thyroid medications during the 6-week treatment period.
- •10. Participants must be euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine [FT3] 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 entire duration of the clinical trial.
- •11. Stable dose of allowed concomitant medications (e.g. antidepressants) for 3 months from Baseline.
- •12. Participants who are rendered euthyroid by the block-and-replace regimen (methimazole + adding levothyroxine) when FT4 and T3 have become normal are allowed.
- •13. Willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •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 10
排除标准
- •1. Use of oral and/or IV corticosteroid use for conditions other than GO within 3 weeks prior to Screening (topical steroids for dermatological conditions are allowed). These cannot be initiated during the trial.
- •2. Use of any steroid (IV or oral) with a cumulative dose equivalent to = 1 g of methylprednisolone for the treatment of GO within 3 weeks prior to Screening.
- •3. Previous steroid use (IV or oral) with a cumulative dose of <1 g methylprednisolone or equivalent for the treatment of GO and previous use of steroid eye drops is allowed if the corticosteroid was discontinued at least 3 weeks prior to Screening.
- •4. Use of rituximab, tocilizumab, or any monoclonal antibody/Fc-fusion biologic for immunomodulation within the past 9 months prior to Baseline.
- •5. Use of selenium within 3 weeks prior to Baseline and use during the clinical trial (multivitamins that include selenium are allowed).
- •6. Use of biotin within 48 hours prior to any laboratory collection (this includes multivitamins that include biotin).
- •7. Participants with = 2 pts (CAS) or 2 mm (proptosis) decrease between screen & baseline.
- •8. Total IgG level < 6g/L at Screening.
- •9. Absolute neutrophil count <1500 cells/mm3 at Screening.
- •10. Participants with 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 at Screening.
- •11. Previous orbital irradiation or surgery for GO.
- •12. Participant has any laboratory abnormality (at screening) that, in the opinion of the investigator, is clinically significant, has not resolved at baseline, and could jeopardize or would compromise the participant's ability to participate in this study.
- •13. Have known autoimmune disease other than GO, that would in the opinion of the Investigator and Medical Monitor, that would interfere with the course and conduct of the study.
- •14. Medical history of primary immunodeficiency, T-cell or humoral, including common variable immunodeficiency.
- •15. Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to Screening.
- •16. History of or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Participants must have negative test results for HBV surface antigen, HBV core antibody, HCV antibody, HIV 1 and 2 antibodies, and a negative QuantiFERON®-TB Gold test at Screening. Participants with an indeterminate QuantiFERON®-TB Gold test result will be allowed one retest; if not negative on retesting, the participant will be excluded.
- •17. Participant has any clinically significant history of allergic conditions (including drug allergies, anaphylactic reactions), that would in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
- •18. Participant has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study
- •19. Body Mass Index (BMI) at Screening = 35 kg/m2.
- •20. Use of investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) before Screening.
- •21. Currently participating or has participated in another GO clinical study within 28 days prior to signing the informed
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