Table 5.
An overview of the current and recently completed clinical trials investigating novel treatments for thyroid eye disease.
| NCT Number (Start-End Date) |
Study Phase | Drug | Mechanism of Action | Study Title |
|---|---|---|---|---|
|
NCT04598815 (2023–2025) |
Phase II | Sirolimus | Inhibits T cell proliferation and fibroblast proliferation | Sirolimus for Graves’ Orbitopathy (GO) (SIRGO) |
|
NCT04936854 (2023–2026) |
Phase II | Sirolimus | Immunosuppression: inhibits T-cell activation, inhibits the IGF-1 pathway, anti-fibroblast effects | Sirolimus vs. Corticosteroids in Treatment of Thyroid Eye Disease |
| NCT05126147 (2022–2024) | Phase IV | Hydroxychloroquine | Inhibits proliferation and adipogenesis in orbital fibroblasts | Hydroxychloroquine in Mild Graves’ Orbitopathy |
| NCT04359979 (2020–2023) | N/A | Tamsulosin | Inhibits catecholamine alpha-1 receptors | Tamsulosin for Thyroid Lid Retraction |
| NCT05394857 (2022–2023) | Phase II | Vunakizumab | Antibody targeting IL-17a, preventing interaction with receptor | Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves’ Orbitopathy Patients |
|
NCT04737330 (2021–2023) |
Phase III | Secukinumab | Antibody targeting IL-17a, preventing interaction with receptor | A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED) (ORBIT) |
|
NCT05331300 (2022–2025) |
Phase I/II | LASN01 | Antibody against IL-11R | A Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease |
|
NCT05002998 (2021–2025) |
Phase IV | Teprotumumab | Antibody that inhibits IGF-1R | TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study |
| NCT05276063 (2022–2026) | Phase IIb | Linsitinib | Small molecule that Inhibits intrinsic tyrosine kinase activity of IGF-1R and IR | A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (LIDS) |
| NCT05176639 (2021–2023) | Phase I, II, III | VRDN-001 | Antibody that Inhibits IGF-1R | A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (THRIVE) |
|
NCT06021054 (2023–2025) |
Phase III | VRDN-001 | Antibody that Inhibits IGF-1R | 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) (THRIVE-2) |
|
NCT06384547 (2024–2026) |
Phase III | VRDN-001 | Antibody that Inhibits IGF-1R | A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (STRIVE) |
|
NCT05683496 (2023–2024) |
Phase I-II | Lonigutamab | Inhibits IGF-1R | A Phase 1/2, Adaptive, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of Lonigutamab in Subjects With Thyroid Eye Disease (TED) |
|
NCT04876534 (2022–2023) |
Phase II | Tocilizumab | Antibody that inhibits membrane-bound and soluble IL-6R | Tocilizumab in Active Moderate-severe Graves’ Orbitopathy (TOGO) |
| NCT05987423 | Phase III | Satralizumab | Humanized monoclonal antibody targeting IL-6R | Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Moderate-To-Severe Thyroid Eye Disease |
|
NCT02378298 (2011–2024) |
Phase IV | Rituximab | Antibody that inhibits CD-20 on B lymphocytes | Rituximab (RTX) Therapy in Patients With Active TAO |
| EudraCT Number: 2015-002127-26 (2015-ongoing) |
Phase II | Belimumab | Antibody targeting BLyS resulting in the inhibition of B cell differentiation and triggering apoptosis | Comparison between treatment with belimumab and methylprednisolone in Graves’hyperthyroidism (GD) and active orbitopathy (GO). |
|
NCT05517421, NCT0552457 (2022–2025) |
Phase III | Batoclimab | Inhibits binding of FcRn to anti-TSHR autoantibodies, leading to degradation of anti-TSHR autoantibodies | Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease |