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The main objective of this trial is to assess the efficacy of AMG 732 in participants with thyroid eye disease (TED) who are defined as primary nonresponders or relapsed during the safety follow-up in the parent trial (NCT06401044).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 732 | Experimental | Participants will receive AMG 732 subcutaneously (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 732 | Drug | AMG 732 will be administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial | Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial | Baseline and Week 24 | |
| Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial |
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Inclusion Criteria
Exclusion Criteria
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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 trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication (or other new use) 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 trial.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/ trials 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye. |
| Week 24 |
| Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial | Baseline and Week 24 |
| Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial | Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye. | Week 24 |
| Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial | Baseline and Week 24 |
| Trough Concentration (Ctrough) of AMG 732 | Baseline to Week 24 |
| Maximum Observed Concentration (Cmax) of AMG 732 | Baseline to Week 24 |
| Time to Cmax (tmax) of AMG 732 | Baseline to Week 24 |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 732 | Baseline to Week 24 |
| Half-life (t1/2) of AMG 732 | Baseline to Week 24 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESEAs), Adverse Events Leading to Investigational Product Discontinuation and Events of Interest (EOIs) | Up to Week 48 |
| Ilumina Medical Research |
| Recruiting |
| Kissimmee |
| Florida |
| 34744 |
| United States |
| Eb Group Spolka z ograniczona odpowiedzialnoscia | Recruiting | Warsaw | 00-189 | Poland |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | Andalusia | 41009 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| 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 |