2024-514110-12-00招募中2 期
A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects with Moderate-to-Severe Active Thyroid Eye Disease
Amgen Inc.19 个研究点 分布在 6 个国家目标入组 16 人开始时间: 2025年9月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 19
- 主要终点
- Change from baseline at week 9999 in proptosis measurement by an exophthalmometer in the study eye
研究概览
简要总结
To investigate the efficacy of AMG 732 in subjects with TED after multiple subcutaneous doses
研究设计
- 分配方式
- Randomized
- 主要目的
- Part B/Phase 2
- 盲法
- Double (Investigator, Analyst, Carer, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent before initiation of any study-specific activities/procedures.
- •Male or female aged 18 to 55 years for Part A and male or female aged 18 to 65 years for Part B 65 years for Part B, inclusive, at the time of informed consent.
- •Part B only: Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with 2 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and inconstant or constant diplopia.
- •Part B only: Subject had onset of active TED symptoms (as determined by subject records) within 15 months prior to baseline
- •Part B only: Clinical diagnosis of Graves disease associated with active TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at screening and baseline
- •Part B only: Proptosis ≥ 18 mm in the study eye at baseline.
- •Part B Only: Subjects with baseline subjective binocular diplopia score > 0
- •Part B Only: Subjects must be euthyroid with the baseline disease under control or have mild hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels < 50% below or above 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 full duration of the trial.
- •Part B Only: Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial
排除标准
- •Malignant condition in the past 12 months (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ)
- •The subject has a major surgery within 8 weeks prior to the first dose of study drug or plans to have an elective surgery from screening through end of study.
- •Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing.
- •History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined in this section) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
- •Part B only: Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, 9999) to the best of the subject and investigator’s knowledge, except when an eligible patient is contraindicated for 9999 in which case 9999 is not required. Also when subject did not consent for 9999 is not required.
- •Subjects with a history of 9999, such as
- •Laboratory Parameters for active liver disease, hepatic dysfunction or 9999 as determined by Part A: ALT or aspartate aminotransferase (AST) levels > 1.5 times upper limit of normal (ULN) Part B: ALT or AST levels > 3 times ULN or glomerular filtration rate ≤ 30 mL/min/1.73 m2 at screening. 9999
- •Positive test for hepatitis B serology at screening defined as: (1) positive for hepatitis B surface antigen (HBsAg); OR (2) positive for hepatitis B core antibody (HBcAb). Patients HBsAg negative, hepatitis B surface antibody (HBsAb) positive and HBcAb negative due to vaccination are eligible for the study. Patients HBsAg negative and HBsAb positive for which the cause cannot be determined as vaccination will be considered ineligible for the study
- •Positive test for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) antibody at screening or within the last 12 months. Subjects successfully treated for an HCV infection are allowed to participate if a sustained virologic response was achieved, defined as aviremia 24 weeks after completion of the antiviral therapy.
- •Subject tested positive for alcohol and/or drugs of abuse at screening
- •Part A: History of substance abuse (eg, alcohol, nicotine or tobacco, and licit or illicit drugs) within 12 months before screening. Part B only: History of substance abuse (eg, alcohol and illicit drugs) within 12 months before screening.
结局指标
主要结局
Change from baseline at week 9999 in proptosis measurement by an exophthalmometer in the study eye
Change from baseline at week 9999 in proptosis measurement by an exophthalmometer in the study eye
次要结局
- Subject incidence of treatment-emergent adverse events, including serious adverse events
- PK parameters including but not limited to maximum observed concentration (Cmax), time to maximum observed concentration (Tmax), area under the concentration time curve (AUC) over the dosing interval, accumulation following multiple dosing, and if feasible, half-life (t1/2) as data permits.
- Subject incidence of antidrug antibodies (ADAs)
- Mean change from Baseline at Week 9999 in the GO-QoL Visual Functioning (VF) subscale score
- Proptosis response status in the study eye 9999 proptosis in the fellow eye) at week 9999
- Mean change from Baseline at Week 9999 in the GO-QoL Appearance (A) subscale score
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (19)
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