Teprotumumab
Sponsors
Horizon Therapeutics USA Inc., Amgen
Conditions
Diabetic Macular EdemaGraves' OrbitopathyHealthy VolunteersModerate-to-Severe Active Thyroid Eye DiseaseThyroid Associated OphthalmopathiesThyroid Eye DiseaseThyroid-Associated Ophthalmopathy
Phase 1
A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)
CompletedNCT02103283
Start: 2014-10-31End: 2016-08-31Updated: 2025-06-25
A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease
CompletedNCT06389578
Start: 2022-07-14End: 2023-09-12Updated: 2024-06-21
A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants
CompletedNCT06674941
Start: 2023-03-24End: 2023-11-14Updated: 2024-11-05
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
CompletedNCT07142642
Start: 2025-08-26End: 2026-01-15Updated: 2026-02-27
Phase 2
Phase 3
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
CompletedNCT03298867
Start: 2017-10-04End: 2020-11-30Updated: 2024-07-11
Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study
CompletedNCT03461211
Start: 2018-04-16End: 2021-02-17Updated: 2024-06-28
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
Active, not recruitingNCT06248619
Start: 2024-07-05End: 2026-11-13Updated: 2026-07-07
A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab
Active, not recruitingCTIS2024-515090-96-00
Start: 2022-05-10Target: 214Updated: 2026-01-19
A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants with Moderate-to-Severe Active Thyroid Eye Disease
RecruitingCTIS2024-515702-63-00
Start: 2025-02-20Target: 31Updated: 2025-12-03
Phase 4
Unknown Phase
Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease
NCT04040894
Updated: 2024-06-20
Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients
CompletedNCT07085117
Start: 2025-07-02End: 2025-08-10Updated: 2025-09-08