Trial Profile
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 28 Jun 2023
Price :
$35
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At a glance
- Drugs Teprotumumab (Primary)
- Indications Graves ophthalmopathy
- Focus Registrational; Therapeutic Use
- Acronyms OPTIC
- Sponsors Horizon Pharma USA
- 26 Jun 2023 According to a Horizon Therapeutics media release, based on this trial the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED.
- 18 Jun 2023 Results of pooled analysis from European Study Sites Participating in the Phase 2, OPTIC (Phase 3) and OPTIC-X trials , presented at the 105th Annual Meeting of the Endocrine Society
- 01 Jul 2022 Results of post hoc analysis from NCT01868997 and NCT03298867 evaluating variability in the time taken to manifest a clinically significant response to teprotumumab, published in the Eye