11 completed, 2 active not recruiting, 2 not yet recruiting, 1 approved for marketing. 6 Phase 1, 3 Phase 3, 3 Phase 4, 2 Phase 2, 1 Early Phase 1.
Follow teprotumumab: new trials by email Literature Review of teprotumumab trials Research Report on teprotumumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy Teprotumumab N01, Intravenous Methylprednisolone (IVMP) - Thyroid Eye Disease, TED, Graves Ophthalmopathy | Phase 2 | Not yet recruiting | Sun Yat-sen University | 60 | 2026-08-01 | 2026-05-19 |
| Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease Teprotumumab Injection [Tepezza] - Thyroid Eye Disease, Thyroid Eye Disease, TED | Phase 4 | Not yet recruiting | Sheba Medical Center | 40 | 2026-01-01 | 2025-12-30 |
| A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants Teprotumumab, Placebo - Healthy Volunteers | Phase 1 | Completed | Amgen | 20 | 2025-08-26 | 2026-02-27 |
| Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients Teprotumumab - Thyroid Eye Disease | Completed | Amgen | 5 | 2025-07-02 | 2025-09-08 | |
| Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab) - mCRPC | Early Phase 1 | Active not recruiting | Shanghai Changzheng Hospital | 7 | 2025-03-10 | 2026-07-23 |
| A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease Teprotumumab, Placebo - Thyroid Eye Disease | Phase 3 | Active not recruiting | Amgen | 89 | 2024-07-05 | 2026-07-07 |
| A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants Teprotumumab - Healthy Volunteers | Phase 1 | Completed | Amgen | 44 | 2023-03-24 | 2024-11-05 |
| A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease Teprotumumab - Thyroid Eye Disease | Phase 1 | Completed | Amgen | 16 | 2022-07-14 | 2024-06-21 |
| A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) TEPEZZA, Placebo - Diffuse Cutaneous Systemic Sclerosis | Phase 1 | Terminated | Amgen | 3 | 2021-11-17 | 2024-06-28 |
| TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study Teprotumumab, Placebo - Thyroid Eye Disease | Phase 4 | Completed | Amgen | 313 | 2021-09-16 | 2026-08-21 |
| A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease TEPEZZA, Placebo - Thyroid Eye Disease, Chronic (Inactive) Thyroid Eye Disease | Phase 4 | Completed | Amgen | 62 | 2021-09-02 | 2024-07-01 |
| The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction Teprotumumab Injection [Tepezza] - Thyroid Eye Disease, Graves Ophthalmopathy | Recruiting | Walter Reed National Military Medical Center | 100 | 2021-05-12 | 2024-02-23 | |
| A Study of TEPEZZA Subcutaneous Administration in Healthy Adults TEPEZZA, EDP - Bioavailability, Bioequivalence | Phase 1 | Completed | Amgen | 37 | 2020-09-22 | 2024-08-21 |
| Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study Teprotumumab - Thyroid Eye Disease | Phase 3 | Completed | Amgen | 51 | 2018-04-16 | 2024-06-28 |
| Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study Teprotumumab, Placebo - Thyroid Eye Disease, Graves' Orbitopathy | Phase 3 | Completed | Amgen | 83 | 2017-10-04 | 2024-07-11 |
| A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME) Teprotumumab - Diabetic Macular Edema | Phase 1 | Completed | Amgen | 5 | 2014-10-01 | 2025-06-25 |
| Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease teprotumumab, normal saline - Thyroid Associated Ophthalmopathies, Thyroid-Associated Ophthalmopathy | Phase 2 | Completed | Amgen | 88 | 2013-07-01 | 2024-12-17 |
| Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease Teprotumumab - Thyroid Eye Disease, Graves' Orbitopathy | Approved for marketing | Amgen | 2024-06-20 |
Graves Ophthalmopathy (15) · Exophthalmos (3) · Bronchiolitis Obliterans Syndrome (1) · Eye Diseases (1) · Graves Disease (1) · Hyperthyroidism (1) · Insulin-Like Growth Factor I, Resistance To (1) · Neoplasm Metastasis (1) · Optic Nerve Diseases (1) · Prostatic Neoplasms (1) · Scleroderma, Diffuse (1) · Sedentary Behavior (1)
Amgen (14) · Shanghai Changzheng Hospital (1) · Sheba Medical Center (1) · Sun Yat-sen University (1) · Walter Reed National Military Medical Center (1)
United States (13) · Germany (5) · Italy (5) · China (4) · United Kingdom (3) · France (2) · Spain (2) · Argentina (1) · Australia (1) · Canada (1) · Japan (1) · Taiwan (1)
Shancheng Ren, MD,PhD (1) · Thanh D Hoang, DO (1)
PMID 33768488, PMID 24651704, PMID 28467880, PMID 31971679, PMID 33172865, PMID 42837042
2017 (2), 2014 (1)