Thyroid Eye Disease (TED) Clinical Trials

thyroid eye disease TED clinical trial tourmaline
argenx graves disease clinical trial
Viridian BLA Community Letter

Kriya Gene Therapy for Thyroid Eye Disease Research and Solutions

Kriya Therapeutics is a biopharmaceutical company developing gene therapies to address common chronic diseases of high unmet need. Our mission is to make gene therapies accessible – not just for the few – but for the many.

Kriya is developing KRIYA-586, an investigational one-time gene therapy for thyroid eye disease (TED) designed to be delivered by an in-office peribulbar injection. KRIYA-586 is an adeno-associated virus (AAV) gene therapy engineered to express an antibody that inhibits Insulin-Like Growth Factor 1 Receptor (IGF1R).

The RECLAIM Study is an adaptive Phase 1/2 multicenter study evaluating the safety, tolerability, pharmacokinetics, and efficacy of KRIYA-586 in patients with moderate to severe TED.

Thyroid Eye Disease Clinical Trial
https://clinicaltrials.gov/study/NCT07404111

KRIYA-586 is an investigational therapy and has not been approved as safe or effective by the FDA or any other regulatory health authority.

https://www.argenx.com/

VitaliThy

Official Study Name:
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease (VitaliThy)

ClinicalTrials.gov ID: NCT07596849
• Other study numbers: ARGX-113-25-GRD-3001; ARGX-113-25-GRD-3002
• 2025-524223-42-00 ( EU Trial (CTIS) Number )
• 2025-523333-26-00 ( EU Trial (CTIS) Number )

Mode of delivery: Subcutaneous injection via Prefilled Syringe (PFS)

Primary Outcome Measure:
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A

Some Secondary Outcome Measures:

  • Time to become euthyroid off ATDs in part A
  • Percentage of participants who are euthyroid and receiving methimazole (MMI) ≤5 mg/day or carbimazole (CBZ) ≤7.5 mg/day at week 24 in part A
  • Percentage of participants with fT3 and fT4 levels below the Upper limit of Normal (ULN) off Anti-Thyroid Drugs (ATDs) at week 24 in part A
  • Percentage of participants who are euthyroid off ATDs and anti-TSHR autoantibodies (TRAb) seronegative at week 24 in part A
  • Time to becoming euthyroid off ATDs and TRAb seronegative
  • Time to become euthyroid and receiving an ATD dose of MMI ≤5 mg/day or CBZ ≤7.5 mg/day (part A)
  • Time to become euthyroid
  • Time to having fT3 and fT4 levels within normal ranges among participants who had fT3 and/or fT4 more than the upper limits of normal at baseline (part A)
  • Time to having thyroid-stimulating hormone (TSH) within normal ranges among participants who have TSH lower than the lower limit of normal (LLN) at baseline (part A)
  • Percentage of participants who remain euthyroid without ATDs
  • Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months
  • Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS
  • Incidence of adverse events (AEs) and serious adverse events (SAEs)
  • Change in the Thyroid-Specific Patient-Reported Outcome Short Form (ThyPRO-39 ) over time
  • Change in Patient-Reported Outcomes Measurement Information System Physical Function – 10 items (PROMIS-PF10a ) over time
  • Other secondary endpoints listed on clinicaltrials.gov

Sponsor: argenx

Study Overview:

The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves’ Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.

The study consists of a part A double-blind treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During part A and part B treatment periods, participants will receive efgartigimod PH20SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant’s response to treatment.

The total study duration for participants ranges from 63-135 weeks, depending on the response to the treatment.

Intervention/Treatment

  • Biological: efgartigimod PH20 SC
  • Other: PH20 SC

Contacts and locations

Study Contact

Name: Sabine Coppieters, MD

Phone Number: 857-350-4834

Email: clinicaltrials@argenx.com

Inclusion Criteria

  • Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
  • Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels >=ULN (upper limit of normal) at screening
  • Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) <0.1 mIU/L at screening
  • Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening

Exclusion Criteria

  • History of hyperthyroidism is not caused by GD (eg, toxic adenoma or toxic multinodular goiter)
  • History of RAI (radioactive iodine) therapy or received a total thyroidectomy
  • T3- or T4-containing medication or supplements (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received <6 weeks before screening
  • Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.
  • Graves’ orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, or orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study

amgen rare disease logo
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.

IN THE NEWS 
THOUSAND OAKS, Calif., April 6, 2026 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced positive topline results from a Phase 3 trial of TEPEZZA (teprotumumab-trbw) administered by subcutaneous injection via an on-body injector (OBI) in participants with moderate-to-severe active Thyroid Eye Disease (TED). TEPEZZA OBI provides comparable efficacy to, and builds upon the success of, intravenous (IV) TEPEZZA, the first and only medicine approved for the treatment of TED, which has now treated more than 25,000 patients worldwide.

Read the full press release.

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

sling therapeutics

Sling Therapeutics’ is investigating a convenient oral small molecule linsitinib for thyroid eye disease (TED).

Linsitinib works by inhibiting the validated IGF-1R target.

Note: Linsitinib is not approved as a marketed product at this time. Clinical trials are required by the FDA to demonstrate the safety and efficacy of a potential medication before general availability.

immunovant solutions for thyroid eye disease

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

viridian therapeutics

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.

Genentech - a member of Roche - logo

We’re Genentech. Our love of science compels us to explore new avenues of research and untapped technological possibilities in pursuit of solutions that reduce the burden of complex health challenges on patients.

As biotech’s original changemakers, we deliver life-changing breakthroughs – from creating the next generation of therapies, to accelerating the drug discovery process – improving healthcare access and outcomes for all patients.

We are inclusive, passionate, vibrant and courageous, constantly working towards a shared goal of a healthier future.

Genentech is committed to improving health outcomes within the communities we serve. We do this by supporting and promoting organizations and initiatives that offer new opportunities for care and by improving access to health services and information.

About Thyroid Eye Disease

On Our Watch List

Alumis is investigating a medication for thyroid eye disease. Lonigutamab, a next-generation anti-IGF-1R, is being explored as a potential TED treatment, offering a convenient subcutaneous route of administration and safety benefit while retaining the clinically validated efficacy of an anti-IGF-1R. 

More information:
https://www.alumis.com/pipeline/lonigutamab/

About TED Community Organization
This thyroid eye disease and Graves’ disease patient advocacy group frequently maintains an updated, accessible list of open TED clinical program.