Clinical trials: Thyroid Associated Orbitopathy
Thyroid Eye Disease
An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R).
- Trial name
- OLE (NCT06179875)
- Testing
- Veligrotug
- Where
- 45 sites in United States, France and 6 more
- Volunteers
- 139 people
- Sponsor
- Viridian Therapeutics, Inc.
Thyroid Eye Disease, Graves' Orbitopathy
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
The overall objective is to investigate the efficacy, tolerability, and safety of teprotumumab (a fully human monoclonal antibody [mAb] inhibitor of the insulin-like growth factor-1 receptor [IGF-1R]) administered once every 3…
- Trial name
- OPTIC (NCT03298867)
- Testing
- Teprotumumab
- Where
- 14 sites in United States, Germany and 1 more
- Volunteers
- 83 people
- Sponsor
- Amgen
Graves Disease, Graves Disease (Basedow's Disease)
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Graves' disease is an autoimmune condition that causes an overactive thyroid. Some people with Graves' disease develop thyroid eye disease, also called Graves' orbitopathy, which can cause swelling around the eyes, eye…
- Conditions
- Graves Disease, Graves Disease (Basedow's Disease), Graves Orbitopathy, Graves Ophthalmopathy
- Trial name
- ATORGO (NCT07883356)
- Testing
- Atorvastatin
- Where
- 7 sites in Sweden
- Volunteers
- 554 people
- Sponsor
- Region Skane
Thyroid Eye Disease
A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R).
- Trial name
- STRIVE (NCT06384547)
- Testing
- Veligrotug
- Where
- 50 sites in United States, Australia and 5 more
- Volunteers
- 231 people
- Sponsor
- Viridian Therapeutics, Inc.
Thyroid Eye Disease
A Safety, Tolerability, and Efficacy Study of Veligrotug (VRDN 001) in Participants With Thyroid Eye Disease (TED)
The investigational drug, veligrotug (VRDN-001), is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R).
- Trial name
- THRIVE (NCT05176639)
- Testing
- Veligrotug
- Where
- 53 sites in United States, Australia and 5 more
- Volunteers
- 113 people
- Sponsor
- Viridian Therapeutics, Inc.
Thyroid Eye Disease, Graves' Orbitopathy
Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease
This is an expanded access protocol intended to provide access to teprotumumab for the treatment of up to 60 patients in the United States with active moderate to severe thyroid eye disease where there is no comparable or…
- Trial name
- EAP (NCT04040894)
- Testing
- Teprotumumab
- Where
- 8 sites in United States
- Sponsor
- Amgen
Thyroid Associated Ophthalmopathies, Thyroid-Associated Ophthalmopathy
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment…
- Trial name
- NCT01868997
- Testing
- teprotumumab, normal saline
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 88 people
- Sponsor
- Amgen
Thyroid-Associated Ophthalmopathy
Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease
The purpose of this study is to determine whether Sirolimus is more effective and burdened with less side effects than conventional treatment with corticosteroids in patients with active thyroid eye disease.
- Trial name
- NCT04936854
- Testing
- Sirolimus 1 mg Oral Tablet, Methylprednisolone
- Where
- Norway
- Volunteers
- 60 people
- Sponsor
- Haukeland University Hospital
Bioavailability, Bioequivalence
A Study of TEPEZZA Subcutaneous Administration in Healthy Adults
The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.
- Trial name
- NCT06563856
- Testing
- TEPEZZA, EDP
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Amgen
Graves' Disease, Graves Ophthalmopathy
Coagulation After Intravenous Methylprednisolone Administration
The alterations of coagulation and fibrinolysis parameters have been described in patients with endogenous Cushing's syndrome (CS) and those treated with glucocorticosteroids (GCs).
- Conditions
- Graves' Disease, Graves Ophthalmopathy, Blood Coagulation, Venous Thromboembolism
- Trial name
- NCT03535090
- Testing
- Methylprednisolone
- Volunteers
- 26 people
- Sponsor
- Piotr Miskiewicz
Thyroid Associated Ophthalmopathies, Graves´ Ophthalmopathy
Tocilizumab Treatment in Graves´ Ophthalmopathy (Graves´ Orbitopathy or Thyroid Eye Disease)
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.
- Conditions
- Thyroid Associated Ophthalmopathies, Graves´ Ophthalmopathy, Thyroid Eye Disease
- Trial name
- GRC (NCT01297699)
- Testing
- Tocilizumab (RoActemra®), Sterile 0.9% Sodium Chloride
- Where
- 9 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Hospital Clinico Universitario de Santiago
Graves Ophthalmopathy, Graves Disease
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy (GO).
- Conditions
- Graves Ophthalmopathy, Graves Disease, Eye Diseases, Thyroid Diseases
- Trial name
- NCT01727973
- Testing
- Doxycycline
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Sun Yat-sen University
Thyroid Associated Opthalmopathies
Prednisone Versus Doxycycline in the Treatment of Graves' Orbitopathy
The aim of this study is to compare the efficacy and safety of prednisone versus sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe Graves' Orbitopathy (GO).
- Trial name
- NCT01809444
- Where
- 6 sites in China
- Volunteers
- 146 people
- Sponsor
- Sun Yat-sen University
Thyroid Associated Ophthalmopathy, Hypercholesterolemia
Effects of Atorvastatin in Graves' Orbitopathy (GO)
Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease (GD), being observed in ~25% of patients.
- Trial name
- STAGO (NCT03110848)
- Testing
- Atorvastatin, Methylprednisolone
- Where
- Italy
- Volunteers
- 88 people
- Sponsor
- University of Pisa
Graves Ophthalmopathy, Thyroid Associated Ophthalmopathy
Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy…
- Conditions
- Graves Ophthalmopathy, Thyroid Associated Ophthalmopathy, Thyroid Associated Orbitopathy
- Trial name
- NCT03131726
- Testing
- Simvastatin 40mg
- Where
- Sweden
- Volunteers
- 80 people
- Sponsor
- Lund University
Thyroid Eye Disease
An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab
This is a clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but…
- Trial name
- NCT07832136
- Testing
- veligrotrug (LUMVOA™)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Viridian Therapeutics, Inc.
Thyroid Eye Disease, Graves Orbitopathy
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs.
- Conditions
- Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases, Eye Diseases
- Trial name
- LIDS (NCT05276063)
- Testing
- Linsitinib
- Where
- 30 sites in United States, Canada and 3 more
- Volunteers
- 90 people
- Sponsor
- Sling Therapeutics, Inc.
Thyroid Eye Disease
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic Thyroid Eye Disease (TED).
- Trial name
- REVEAL-2 (NCT06625398)
- Testing
- VRDN-003
- Where
- 60 sites in United States, Germany and 4 more
- Volunteers
- 204 people
- Sponsor
- Viridian Therapeutics, Inc.
Graves Ophthalmopathy, Graves Disease
Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild Thyroid-Associated Ophthalmopathy (TAO).
- Conditions
- Graves Ophthalmopathy, Graves Disease, Thyroid-associated Ophthalmopathy, Thyroid Diseases
- Trial name
- NCT02203682
- Testing
- Doxycycline hyclate
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sun Yat-sen University
Thyroid Associated Ophthalmopathies
Selenium in Mild Thyroid Eye Disease in North America
The purpose of this study is to determine whether sodium selenite is helpful in the treatment of mild thyroid eye disease in North America.
- Trial name
- S-ITEDS (NCT02112643)
- Testing
- Sodium selenate, Sugar pill
- Sponsor
- Columbia University