Thyroid Eye Disease Clinical Trial
Official title:
A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients With Chronic (Inactive) Thyroid Eye Disease
The overall objective is to investigate the efficacy, safety and tolerability of TEPEZZA® in participants with chronic (inactive) TED (thyroid eye disease). Approximately 57 participants will be enrolled. There will be a treatment period (through Week 24) and a follow up period (where TEPEZZA will not be infused).
This is a randomized, double-masked, placebo-controlled, parallel-group, multicenter trial. Participants will be screened for the trial within 4 weeks prior to Baseline (Day 1). Approximately 57 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 2:1 ratio to receive 8 infusions of TEPEZZA or placebo once every 3 weeks. All participants will enter a 24-week double-masked Treatment Period, during which trial drug will be infused on Day 1 (Baseline) and Weeks 3, 6, 9, 12, 15, 18 and 21 (with a final visit at Week 24 of the 24-week Treatment Period). At the end of the double-masked Treatment Period (Week 24), all patients will be assessed for treatment response. Non-responders may choose to receive 8 infusions of TEPEZZA in an open-label fashion q3W at Weeks 24, 27, 30, 33, 36, 39, 42 and 45. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| 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| Withdrawn |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 | |
| 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 | |
| Recruiting |
NCT06226545 -
A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
|
Phase 2 | |
| Terminated |
NCT02845336 -
Celecoxib for Thyroid Eye Disease
|
Phase 2 | |
| Recruiting |
NCT06307626 -
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.
|
Phase 3 | |
| Recruiting |
NCT06307613 -
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease
|
Phase 3 |