The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.
Recruitment has ended for the Phase 1 portion of the study and will reopen when Phase 2 begins recruitment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Part A: Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 through Week 36 (End of Study)
Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye
Time frame: Baseline to End of Treatment (EoT) (approximately 6 Months)
Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732
Time frame: Up to Week 36
Part A: Time to Cmax (Tmax) of AMG 732
Time frame: Up to Week 36
Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732
Time frame: Up to Week 36
Part A: Half-life (t1/2) of AMG 732
Time frame: Up to Week 36
Part A: Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to Week 36
Part B: Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to Week 48
Part B: Cmax of AMG 732
Time frame: Up to Week 48
Part B: Tmax of AMG 732
Time frame: Up to Week 48
Part B: AUC of AMG 732 Over the Dosing Interval
Time frame: Up to Week 48
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Las Vegas, Nevada, United States
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RECRUITINGConsano Clinical Research, LLC
Shavano Park, Texas, United States
RECRUITINGWest Virginia University
Morgantown, West Virginia, United States
RECRUITINGMacquarie University
North Ryde, New South Wales, Australia
RECRUITING...and 13 more locations
Part B: Accumulation of AMG 732 Following Multiple Dosing
Time frame: Up to Week 48
Part B: Half-life (t1/2) of AMG 732
Time frame: Up to Week 48
Part B: Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to Week 48
Part B: Proptosis Response Status in the Study Eye
Time frame: EoT (approximately 6 Months)
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)
Part B: Mean Change from Baseline in the GO-QoL Appearance (A) Subscale Score
Time frame: Baseline to EoT (approximately 6 Months)