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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508693-29-00 | Other Identifier | CTIS |
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This trial will evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease (TED). TED is an autoimmune condition closely related to Graves' Disease.
In people with TED, the healthy tissue behind and around the eye becomes inflamed and swollen. One of the key symptoms of TED is proptosis (bulging eyes). The main goal of this trial is to learn whether treatment with Lu AG22515 improves proptosis in participants with moderate-to-severe TED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG22515 | Experimental | Participants will receive intravenous (IV) administration of Lu AG22515 per a prespecified dosing schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG22515 | Drug | Solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Serum Concentration of Lu AG22515 | Predose up to Week 52 | |
| Tmax: Time to Maximum Observed Cmax of Lu AG22515 | Predose up to Week 52 | |
| Ctrough: Minimum Observed Serum Concentration of Lu AG22515 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Center of The Republic Of Srpska | Banja Luka | Republika Srpska | 78000 | Bosnia and Herzegovina | ||
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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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| Predose up to Week 52 |
| AUC0-infinity: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Lu AG22515 | Predose up to Week 52 |
| t½: Apparent Elimination Half-life of Lu AG22515 | Predose up to Week 52 |
| CL: Apparent Total Serum Clearance of Lu AG22515 | Predose up to Week 52 |
| Volume of Distribution of Lu AG22515 | Predose up to Week 52 |
| Number of Participants with Anti-drug Antibodies | Up to Week 52 |
| Diagnostic-Consultative Center Alexandrovska |
| Sofia |
| 1431 |
| Bulgaria |
| University Specialized Hospital for Active Treatment in Endocrinology (USHATE) "Acad. Ivan Penchev" | Sofia | 1431 | Bulgaria |
| Jagiellonian University Medical College | Krakow | Lesser Poland Voivodeship | 30-688 | Poland |
| Uniewrsyteckie Centru Kliniczne | Katowice | 40-514 | Poland |
| UnivCentrum Zdrowia MDM EB GROUP Sp.zo.o | Warsaw | 00-189 | Poland |
| 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 |