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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: AMG 732 | Experimental | Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD). |
|
| Part A: Placebo | Placebo Comparator | Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD). |
|
| Part B: AMG 732 Low Dose | Experimental | Participants will receive AMG 732 low dose SC. |
|
| Part B: AMG 732 Medium Dose | Experimental | Participants will receive AMG 732 medium dose SC. |
|
| Part B: AMG 732 High Dose | Experimental | Participants will receive AMG 732 high dose SC. |
|
| Part B: Placebo | Placebo Comparator | Participants will receive placebo SC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 732 | Drug | SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants With Treatment-emergent Adverse Events | Day 1 through Week 36 (End of Study) | |
| Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye | Baseline to End of Treatment (EoT) (approximately 6 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732 | Up to Week 36 | |
| Part A: Time to Cmax (Tmax) of AMG 732 | Up to Week 36 | |
| Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732 |
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Inclusion criteria for Part A/Phase 1 only:
Inclusion criteria for Part B/Phase 2 only:
Exclusion criteria for Part A and Part B:
Exclusion criteria for PartA/Phase 1 only
• Blood pressure or ECG abnormalities at screening.
Exclusion criteria for Part B/Phase 2 only:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Research Center of Arkansas | Recruiting | Little Rock | Arkansas | 72205 | United States | |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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|
| Placebo | Other | SC injection |
|
| Up to Week 36 |
| Part A: Half-life (t1/2) of AMG 732 | Up to Week 36 |
| Part A: Number of Participants With Anti-drug Antibodies (ADAs) | Up to Week 36 |
| Part B: Number of Participants With Treatment-emergent Adverse Events | Up to Week 48 |
| Part B: Cmax of AMG 732 | Up to Week 48 |
| Part B: Tmax of AMG 732 | Up to Week 48 |
| Part B: AUC of AMG 732 Over the Dosing Interval | Up to Week 48 |
| Part B: Accumulation of AMG 732 Following Multiple Dosing | Up to Week 48 |
| Part B: Half-life (t1/2) of AMG 732 | Up to Week 48 |
| Part B: Number of Participants With Anti-drug Antibodies (ADAs) | Up to Week 48 |
| Part B: Proptosis Response Status in the Study Eye | EoT (approximately 6 Months) |
| Part B: Mean Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Visual Functioning (VF) Subscale Score | Baseline to EoT (approximately 6 Months) |
| Part B: Mean Change from Baseline in the GO-QoL Appearance (A) Subscale Score | Baseline to EoT (approximately 6 Months) |
| Amy Patel Jain MD |
| Recruiting |
| Newport Beach |
| California |
| 92660 |
| United States |
| Levenson Eye Associates | Recruiting | Jacksonville | Florida | 32204 | United States |
| Ilumina Medical Research | Recruiting | Kissimmee | Florida | 34744 | United States |
| Sarasota Retina Institute | Recruiting | Sarasota | Florida | 34239 | United States |
| Vision Medical Research, Inc. | Recruiting | Orland Park | Illinois | 60462 | United States |
| Massachusetts Eye and Ear Infirmary | Recruiting | Boston | Massachusetts | 02114 | United States |
| Ppd Las Vegas Research Unit | Recruiting | Las Vegas | Nevada | 89113 | United States |
| Erie Retina Research | Recruiting | Erie | Pennsylvania | 16505 | United States |
| Baylor College of Medicine Medical Center | Recruiting | Houston | Texas | 77030 | United States |
| Consano Clinical Research, LLC | Recruiting | Shavano Park | Texas | 78231 | United States |
| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
| Macquarie University | Recruiting | North Ryde | New South Wales | 2109 | Australia |
| North Shore Private Hospital | Recruiting | St Leonards | New South Wales | 2065 | Australia |
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 0A6 | Canada |
| Santé Québec Est-de-l'Île-de-Montréal - Universitaire | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| CHU de Québec-Université Laval - CUO-Recherche Clinique, Hopital du Saint-Sacrement | Recruiting | Québec | Quebec | G1S 4L8 | Canada |
| Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec | Recruiting | Nantes | 44800 | France |
| Hopital Pitie-Salpetriere | Recruiting | Paris | 75013 | France |
| Universitaetsklinikum Essen | Recruiting | Essen | 45147 | Germany |
| Buergerhospital und Clementine Kinderhospital gGmbH | Recruiting | Frankfurt am Main | 60318 | Germany |
| Universitaetsklinikum Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| Universitaetsklinikum Leipzig AoeR | Recruiting | Leipzig | 04013 | Germany |
| General Hospital of Athens Laiko | Recruiting | Athens | 11527 | Greece |
| Ippokratio General Hospital of Thessaloniki | Recruiting | Thessaloniki | 54642 | Greece |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | 56124 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | 56126 | Italy |
| Azienda Socio Sanitaria Territoriale dei Sette Laghi | Recruiting | Varese | 21100 | Italy |
| Aichi Medical University Hospital | Recruiting | Nagakute-shi | Aichi-ken | 480-1195 | Japan |
| Hayashi Eye Hospital | Recruiting | Fukuoka | Fukuoka | 812-0011 | Japan |
| Kozawa Eye Hospital And Diabetes Center | Recruiting | Mito | Ibaraki | 310-0845 | Japan |
| University of Miyazaki Hospital | Recruiting | Miyazaki | Miyazaki | 889-1692 | Japan |
| Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia | Recruiting | Gdansk | 80-180 | Poland |
| Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo | Recruiting | Poznan | 60-354 | Poland |
| Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa | Recruiting | Swidnica | 58-100 | Poland |
| Eb Group Spolka z ograniczona odpowiedzialnoscia | Recruiting | Warsaw | 00-189 | Poland |
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
| Singapore National Eye Centre | Recruiting | Singapore | 169608 | Singapore |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | Andalusia | 41009 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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