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
94
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Amy Patel Jain MD
Newport Beach, California, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Ilumina Medical Research
Kissimmee, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Vision Medical Research, Inc.
Orland Park, Illinois, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Ppd Las Vegas Research Unit
Las Vegas, Nevada, United States
Erie Retina Research
Erie, Pennsylvania, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
...and 34 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)