Thyroid Eye Disease Clinical Trial
Official title:
A Phase 1b, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Formulations of a Single Subcutaneous Dose of Teprotumumab Followed by Multiple Intravenous Doses of TEPEZZA in Participants With Thyroid Eye Disease
The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.
This is a Phase 1b, open-label, multicenter trial to assess the PK, safety, and tolerability of a single SC dose of lyophilized teprotumumab and high concentration formulation teprotumumab in participants with thyroid eye disease. Approximately 6 participants (in Cohort 1) and approximately 10 participants (in Cohort 2) who meet the trial eligibility criteria will be enrolled in a 1:1 ratio. Study acquired from Horizon in 2024. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04583735 -
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
|
Phase 4 | |
| Active, not recruiting |
NCT05002998 -
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
|
Phase 4 | |
| Withdrawn |
NCT02422368 -
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT03298867 -
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
|
Phase 3 | |
| Recruiting |
NCT05987423 -
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
|
Phase 3 | |
| Recruiting |
NCT06112340 -
A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05517447 -
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
|
Phase 3 | |
| Terminated |
NCT04737330 -
A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)
|
Phase 3 | |
| Recruiting |
NCT05517421 -
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
|
Phase 3 | |
| Recruiting |
NCT04311606 -
Anti-VEGF Therapy for Acute Thyroid Eye Disease
|
Phase 2 | |
| Recruiting |
NCT06106828 -
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2)
|
Phase 3 | |
| Recruiting |
NCT06021054 -
A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
|
Phase 3 | |
| Not yet recruiting |
NCT06413043 -
Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy
|
N/A | |
| Not yet recruiting |
NCT06401044 -
A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
|
Phase 1 | |
| Recruiting |
NCT06384547 -
A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
|
Phase 3 | |
| Recruiting |
NCT06367517 -
Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease)
|
||
| Recruiting |
NCT06275373 -
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
|
||
| Enrolling by invitation |
NCT05241626 -
AS-OCT of the Cornea in Thyroid Diseases
|
||
| Active, not recruiting |
NCT05776121 -
Study of ZB001 in Chinese Patients With Thyroid Eye Disease
|
Phase 1 | |
| Recruiting |
NCT04359979 -
Tamsulosin for Thyroid Lid Retraction
|
N/A |