Thyroid Eye Disease Clinical Trial
Official title:
Clinical Trial Phase III, Parallel Group, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab Administration in Patients With Moderate-to-severe or Sight-threatening Graves' Ophthalmopathy (GO), That Had Not Responded Adequately to Treatment With Intravenous Corticoid Pulses.
The purpose is to investigate tocilizumab administration in patients with moderately to
severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with
corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic
alternative.
The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment
in order to provide a better alternative to surgery for this patients.
Thyroid orbitopathy or Graves´orbitopathy (GO) is manifested for inflammation of the orbital
and periorbital soft tissues. Ten percent of patients with GO will have long-term serious
eye problems.
The cause of the GO is complex. Autoreactive T cells recognize an autoantigen, the TSH
receptor present in the orbit and thyroid follicular cell, secrete cytokines (IL-6), which
stimulate the fibroblasts to synthesize glycosaminoglycan, which draws liquid produce
periorbital edema and muscle, causing exophthalmos.
This approach suggests that inhibition of IL-6 can be an effective treatment for this
problem on the basis that tocilizumab specifically binds to the receptors of the IL-6, both
soluble and membrane-bound. Tocilizumab has been shown to inhibit signaling mediated for
IL-6Rm IL-6Rs.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| 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| Withdrawn |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 | |
| Recruiting |
NCT06248619 -
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
|
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 |
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 |