NIPH Clinical Trials Search

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Thyroid Eye Disease
Date of first enrollment	30/05/2024
Target sample size	88
Countries of recruitment	Australia,Japan,Canada,Japan,France,Japan,Germany,Japan,Greece,Japan,Italy,Japan,Poland,Japan,Singapore,Japan,Spain,Japan,Taiwan,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Experimental: Part B: AMG 732 Low Dose Participants will receive AMG 732 low dose SC. Interventions:Drug: AMG 732 Experimental: Part B: AMG 732 Medium Dose Participants will receive AMG 732 medium dose SC. Interventions:Drug: AMG 732 Experimental: Part B: AMG 732 High Dose Participants will receive AMG 732 high dose SC. Interventions:Drug: AMG 732 Placebo Comparator: Part B: Placebo Participants will receive placebo SC. Interventions:Other: Placebo

Outcome(s)

Primary Outcome

1. Part B: Change from Baseline in Proptosis Measurement by an Ex ophthalmometer in the Study Eye [Time Frame: Baseline to End of Treatment (EoT) (approximately 6 Months)]

Secondary Outcome

1. Part B: Number of Participants With Treatment-emergent Adverse Events [Time Frame: Up to Week 48] 2. Part B: Cmax of AMG 732 [Time Frame: Up to Week 48] 3. Part B: Tmax of AMG 732 [Time Frame: Up to Week 48] 4. Part B: AUC of AMG 732 Over the Dosing Interval [Time Frame: Up to Week 48] 5. Part B: Accumulation of AMG 732 Following Multiple Dosing [Time Frame: Up to Week 48] 6. Part B: Half-life (t1/2) of AMG 732 [Time Frame: Up to Week 48] 7. Part B: Number of Participants With Anti-drug Antibodies (ADAs) [Time Frame: Up to Week 48] 8. Part B: Proptosis Response Status in the Study Eye [Time Frame: EoT (approximately 6 Months)] 9. Part B: Mean Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Visual Functioning (VF) Subscale Score [Time Frame: Baseline to EoT (approximately 6 Months)] 10. Part B: Mean Change from Baseline in the GO-QoL Appearance (A) Subscale Score [Time Frame: Baseline to EoT (approximately 6 Months)]

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Inclusion criteria for Part B/Phase 2 only: 1. Male or female aged 18 to 65 years. 2. Moderate-to-severe active TED. 3. The participant had onset of active TED within 15 months prior to baseline. 4. Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score(CAS) >= 3 for the most severely affected eye at screening and baseline. 5. Proptosis >= 18mm in the study eye at baseline. 6. Participants with baseline subjective binocular diplopia score > 0. 7. Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.
Exclude criteria	Exclusion criteria for Part B: 1. Malignant condition in the past 12 months or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study. 2. Active liver or kidney disfunction at screening. 3. Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening. 4. Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening. 5. Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat injection related reactions or short course of steroid for asthma control. 6. Known hypersensitivity to any of the components of TEPEZZA, AMG 732. 7. History of substance abuse within 12 months before screening. 8. 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 today 1 dosing. Exclusion criteria for Part B/Phase 2 only: 9. Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3months prior to the first injection of study drug. 10. Any previous treatment or enrollment in clinical trials with an IGF-1R inhibitor, such as TEPEZZA (teprotumumab-trbw). 11. Prior orbital irradiation or decompression in the study eye. 12. History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease). Other protocol-defined inclusion/exclusion criteria apply.