Thyroid Eye Disease (TED) Clinical Trials

Amgen is conducting a Clinical Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

Thyroid Eye Disease Clinical Trial 
https://clinicaltrials.gov/study/NCT06248619

Brief Summary
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.

Detailed Description
The main objective of the study is to evaluate the effect of teprotumumab subcutaneous administration versus placebo on the proptosis responder rate (ie, the percentage of participants with a ≥ 2-mm reduction from Baseline in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye) at Week 24.

Tourmaline Bio, Inc. is conducting a clinical trial for thyroid eye disease.

A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease (spiriTED)

Thyroid Eye Disease Clinical Trial
https://clinicaltrials.gov/study/NCT06088979

Brief Summary
Phase 2b trial of TOUR006 in Thyroid Eye Disease (TED) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to TED patients who are in the active inflammatory phase of disease.

Official Title
A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease

Viridian is a biotechnology company based in Waltham, Massachusetts focused on discovering and developing potential new medicines for people living with autoimmune and rare diseases.

Leveraging our team’s expertise in antibody discovery, protein engineering, and clinical development, Viridian is studying multiple potential new treatment options in clinical trials for people living with thyroid eye disease (TED). All of Viridian’s TED clinical trials are fully enrolled, therefore no longer seeking additional participants. For more information on these clinical trials, please visit https://clinicaltrials.gov/search?lead=Viridian or speak with a healthcare provider.

Sling Therapeutics’ convenient oral small molecule linsitinib is in a Phase 2b trial for thyroid eye disease (TED).

Linsitinib works by inhibiting the validated IGF-1R target, and our partnered clinical sites are studying its use in TED (a list of participating sites can be found at the link below).

Thyroid Eye Disease Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT05276063

Brief Summary
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. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).

Official Title
A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

THYROID EYE DISEASE CLINICAL TRIAL

Immunovant is participating in a TED clinical research study. A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)

Thyroid Eye Disease Clinical Trial
Active, not recruiting
https://clinicaltrials.gov/study/NCT05524571

See “Understanding Thyroid Eye Disease” contributed by Immunovant.

GRAVES’ DISEASE CLINICAL TRIAL

Immunovant is also conducting a clinical trial for Graves’ Disease. A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves’ Disease.

Brief Summary

This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves’ disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.

The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

Graves’ Disease Clinical Trial
https://clinicaltrials.gov/study/NCT06727604