Active Clinical Trials

A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (STRIVE)

Clinical Trials.gov ID: NCT06384547
Sponsor: Viridian Therapeutics, Inc.

VRDN-001 is an experimental monoclonal antibody designed to block the insulin-like growth factor-1 receptor (IGF-1R), a protein found on cell surfaces. By blocking this receptor, VRDN-001 may potentially reduce the inflammation and tissue swelling characteristic of thyroid eye disease (TED). This clinical trial’s main goal is to assess how safe and well-tolerated VRDN-001 is in participants with TED.

https://clinicaltrials.gov/study/NCT06384547

An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2) (THRIVE-2)

ClinicalTrials.gov ID NCT06021054
Sponsor Viridian Therapeutics, Inc.

This clinical trial studies whether the experimental drug veligrotug (VRDN-001) is effective and safe for people with chronic thyroid eye disease (TED). Participants are randomly assigned to receive either veligrotug or placebo through five IV infusions given every three weeks over 12 weeks. Neither participants nor researchers know which treatment each person receives. The study evaluates whether veligrotug works safely and is well-tolerated in people with chronic TED.

https://clinicaltrials.gov/study/NCT06021054

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

ClinicalTrials.gov ID NCT05524571
Sponsor Immunovant Sciences GmbH

This study compares Batoclimab (an experimental drug) to placebo to see if it reduces eye bulging in people with active thyroid eye disease. Participants receive weekly injections under the skin for 24 weeks, with researchers measuring improvement in eye bulging at the end of the study.

https://clinicaltrials.gov/study/NCT05524571

A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) (LIDS)

ClinicalTrials.gov ID NCT05276063
Sponsor Sling Therapeutics, Inc.

This study evaluates whether linsitinib, an experimental oral medication taken twice daily, is safe and effective compared to placebo for treating people with active, moderate to severe thyroid eye disease over 24 weeks.

https://clinicaltrials.gov/study/NCT05276063

A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) (LIDS)

ClinicalTrials.gov ID NCT05276063
Sponsor Sling Therapeutics, Inc.

This study tests whether linsitinib (molecule IGF-1R inhibitor) taken orally  twice daily, is safe and effective compared to placebo for treating people with active, moderate to severe thyroid eye disease over 24 weeks.

https://clinicaltrials.gov/study/NCT05276063

TED Adipose Sample IIT- Dr. Alon Kahana, M.D., PhD.

Molecular Analysis of Orbital Tissues and Sera from Patients with Thyroid Eye Disease

Western Institutional Review Board (WCG) IRB Tracking ID: 20243220
Research Grant: Kriya Therapeutics

This is an investigator-initiated trial to assess the biology of TED orbitopathy. This study will help to identify and better understand the signaling pathways activated in the orbital tissue of patients with TED. The goals of this study are to 1) evaluate potential biomarkers of disease and treatment using genomic, metabolomic and proteomic analyses; 2) evaluate IGF1R and/or TSHR expression in orbital tissues; and 3) evaluate teprotumumab levels in snap frozen orbital adipose and/or muscle tissue as well as serum from TED patients who have been treated with teprotumumab within the last 120 days of sample collection.

https://clinicaltrials.gov/study/NCT05517447

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED) (REVEAL-1)

ClinicalTrials.gov ID NCT06625411
Sponsor Viridian Therapeutics, Inc.

This research tests whether VRDN-003 injections given monthly or every two months can effectively and safely treat active thyroid eye disease compared to placebo. Participants who do not improve sufficiently may have the option to try additional VRDN-003 treatments.

https://www.clinicaltrials.gov/study/NCT06625411

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) (REVEAL-2)

ClinicalTrials.gov ID NCT06625398
Sponsor Viridian Therapeutics, Inc.

This research tests whether VRDN-003 injections given monthly or every two months can effectively and safely treat chronic thyroid eye disease compared to placebo. Participants who don’t improve sufficiently may have the option to try additional VRDN-003 treatments.

https://www.clinicaltrials.gov/study/NCT06625398

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

ClinicalTrials.gov ID NCT06088979
Sponsor Tourmaline Bio, Inc.

This Phase 2b study tests whether TOUR006, delivered by subcutaneous injection every eight weeks, is effective for people with active, inflammatory thyroid eye disease. Participants receive either a 20mg dose, 50mg dose, or placebo to determine which works best.

https://clinicaltrials.gov/study/NCT06088979

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

ClinicalTrials.gov ID NCT05517447
Sponsor Immunovant Sciences GmbH

This extension study follows participants who have completed previous batoclimab studies (IMVT-1401-3201 or IMVT-1401-3202). One group continues without treatment to see how long their eye bulging improvement lasts, while the other group receives batoclimab treatment to evaluate whether it reduces proptosis.