For Thyroid Awareness Month 2025, we will be looking into the latest research and clinical trials focused on thyroid eye disease (TED) in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for TED, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of Thyroid Eye Disease Clinical Trials!
Quick View Table of Thyroid Eye Disease Clinical Trials
Phase 3 Clinical Trials:
An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants with Chronic Thyroid Eye Disease (TED) (THRIVE-2)
- Sponsor: Viridian Therapeutics, Inc.
- 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).
- Interventions:
- Drug: Veligrotug (VRDN-001)
- Drug: Placebo
- Primary Outcomes Measures:
- Proptosis Responder Rate in the most proptotic eye
- Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥2 mm from baseline [without a corresponding increase of ≥2 mm in the other eye])
- Time Frame - Week 15
- Proptosis Responder Rate in the most proptotic eye
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study (OPTIC)
- Sponsor: Amgen
- 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 weeks (q3W) for 21 weeks with a final assessment at Week 24, in comparison to placebo, in the treatment of participants with moderate-to-severe active thyroid eye disease (TED).
- Interventions:
- Biological: Teprotumumab
- Other: Placebo
- Primary Outcomes Measures:
- Percentage of Participants Who Were Proptosis Responders at Week 24
- Proptosis responders were defined as participants with a ≥2 mm reduction from Baseline in proptosis in the study eye, without deterioration (≥2 mm increase) of proptosis in the fellow eye at Week 24.
- Time Frame - Week 24
- Percentage of Participants Who Were Proptosis Responders at Week 24
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED) (REVEAL-2)
- Sponsor: Viridian Therapeutics, Inc.
- 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).
- Interventions:
- Drug: VRDN-003
- Drug: Placebo
- Primary Outcomes Measures:
- Title: Proptosis Responder Rate in the study eye
- Description: Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye [without a corresponding increase of ≥2 mm in the fellow eye]
- Time Frame - Week 24
- Title: Proptosis Responder Rate in the study eye
An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
- Sponsor: Immunovant Sciences GmbH
- This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.
- Interventions:
- Other: Observational cohort study
- Drug: Batoclimab
- Primary Outcomes Measures:
- Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
- Time Frame - Up to Week 24
- Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
- Sponsor: Amgen
- The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.
- Interventions:
- Biological: Teprotumumab
- Other: Placebo
- Primary Outcomes Measures:
- Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye).
- Time Frame - Week 24
- Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye).
A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (STRIVE)
- Sponsor: Viridian Therapeutics, Inc.
- 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). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.
- Interventions:
- Drug: VRDN-001 10 mg/kg
- Drug: VRDN-001 3 mg/kg
- Primary Outcomes Measures:
- Treatment Emergent Adverse Event (TEAE) incidence rate
- Time Frame - Week 52
- Treatment Emergent Adverse Event (TEAE) incidence rate
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults with Thyroid Eye Disease (UplighTED)
- Sponsor: argenx
- This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.
- After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks.
- An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307626)
- Interventions:
- Combination Product: Efgartigimod PH20 SC
- Other: Placebo PH20 SC
- Primary Outcomes Measures:
- Percentage of participants who were proptosis responders
- Time Frame - At week 24 of the Double-Blinded Treatment Period
- Percentage of participants who were proptosis responders
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease (SatraGO-2)
- Sponsor: Hoffmann-La Roche
- The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).
- Interventions:
- Drug: Satralizumab
- Drug: Placebo
- Primary Outcomes Measures:
- Percentage of Participants Achieving ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye
- Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye.
- Time Frame - Baseline, Week 24
- Percentage of Participants Achieving ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye
Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
- Sponsor: Columbia University
- The purpose of this research is to find out if SSKI (Potassium Iodide) reduces vascularity (the number and concentration of blood vessels) and improves how well patients do after surgery for removal of their whole thyroid gland in Graves' disease (an autoimmune disease that is a common cause of hyperthyroidism).
- Interventions:
- Drug: SSKI- Potassium Iodide
- Primary Outcomes Measures:
- Change in Vascular Flow From Baseline
- Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.
- Time Frame - From Baseline to Immediately Before Surgery
- Change in Vascular Flow From Baseline
Potential Guideline That May Be Affected Includes:
- Management of Thyroid Eye Disease
- American Thyroid Association/European Thyroid Association
- Publication: December 12, 2022
There you have it - a list of phase 3 Clinical Trials for Thyroid Eye Disease as of January 2025. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.
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