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
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
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
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.
Thyroid Eye Disease (TED)
A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).
- Trial name
- NCT06812325
- Testing
- VRDN-003
- Where
- 64 sites in United States, France and 5 more
- Volunteers
- 320 people
- Sponsor
- Viridian Therapeutics, Inc.
Thyroid Eye Disease
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED).
- Trial name
- REVEAL-1 (NCT06625411)
- Testing
- VRDN-003
- Where
- 48 sites in United States, Germany and 3 more
- Volunteers
- 132 people
- Sponsor
- Viridian Therapeutics, Inc.
Thyroid Eye Disease, Graves Orbitopathy
Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24.
- Conditions
- Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases, Eye Diseases
- Trial name
- NCT06112340
- Testing
- linsitinib
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Sling Therapeutics, Inc.
Thyroid Eye Disease, Graves Ophthalmopathy
A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED).
- Conditions
- Thyroid Eye Disease, Graves Ophthalmopathy, Graves Orbitopathy, Thyroid Associated Ophthalmopathy
- Trial name
- NCT06226545
- Testing
- LASN01
- Where
- 15 sites in United States, Spain and 1 more
- Volunteers
- 41 people
- Sponsor
- Lassen Therapeutics Inc.
Healthy Volunteers
A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants
The primary objective of this trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and…
- Trial name
- NCT06674941
- Testing
- Teprotumumab
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Amgen
Thyroid Eye Disease (TED), Graves Ophthalmopathy
Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)
This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical…
- Conditions
- Thyroid Eye Disease (TED), Graves Ophthalmopathy, Thyroid Associated Ophthalmopathies
- Trial name
- THYROSCOPE-TED (NCT07623993)
- Testing
- Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- THYROSCOPE INC.
Thyroid Eye Disease
An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED)
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).
- Trial name
- THRIVE-2 (NCT06021054)
- Testing
- Veligrotug
- Where
- 57 sites in United States, Australia and 7 more
- Volunteers
- 188 people
- Sponsor
- Viridian Therapeutics, Inc.