A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Phase 3

Recruiting

• Conditions: Thyroid Eye Disease (TED)
• Interventions: Drug: VRDN-003; Drug: Placebo

• Registration Number: NCT06812325
• Lead Sponsor: Viridian Therapeutics, Inc.

Brief Summary

This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).

Detailed Description

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-31
• Study Start: 2025-02-03
• Study First Posted: 2025-02-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• Have a clinical diagnosis of TED with or without proptosis and with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
• Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
• Must agree to use highly effective contraception as specified in the protocol
• Female TED participants must have a negative serum pregnancy test at screening

Exclusion Criteria

• Must not have received prior treatment with another anti-IGF-1R therapy
• Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
• Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 8 weeks prior to first dose
• Must not have received an investigational agent for any condition, including TED, within 8 weeks prior to first dose
• Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
• Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
• Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
• Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
• Must not have a history of inflammatory bowel disease
• Female TED participants must not be pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRDN-003 every 4 weeks	VRDN-003	6 subcutaneous administrations of VRDN-003
VRDN-003 every 8 weeks	VRDN-003	3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
VRDN-003 every 8 weeks	Placebo	3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24	Week 24	Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer	Week 24	Change from baseline in proptosis in the study eye
TEAE incidence rate through Week 52	Week 52	Treatment Emergent Adverse Event (TEAE) incidence rate measurement through Week 52

Trial Locations

Locations (18)

Catalina Eye Care; 🇺🇸 Tuscon, Arizona, United States

Retreat Medical Research; 🇺🇸 Miami, Florida, United States

DFW Clinical Trials; 🇺🇸 Carrollton, Texas, United States

C A Clinical Trial Corp.; 🇺🇸 Cape Coral, Florida, United States

D H Doral Research Center; 🇺🇸 Doral, Florida, United States

Pioneer Research Solutions Inc.; 🇺🇸 Houston, Texas, United States

Elevate Clinical Research; 🇺🇸 Seabrook, Texas, United States

East Coast Institute for Research, LLC; 🇺🇸 Jacksonville, Florida, United States

United Medical Research Institute; 🇺🇸 Inglewood, California, United States

California Eye Specialists Medical Group INC; 🇺🇸 Pasadena, California, United States

FOMAT Medical Research; 🇺🇸 Santa Maria, California, United States

Herco Medical and Research Center; 🇺🇸 Coral Gables, Florida, United States

Sina Medical Center; 🇺🇸 Homestead, Florida, United States

Southern Clinical Research LLC; 🇺🇸 Miami, Florida, United States

Continental Clinical Research; 🇺🇸 Miami, Florida, United States

Edward Jenner Research Group LLC; 🇺🇸 Plantation, Florida, United States

Ophthalmic Consultants of Boston; 🇺🇸 East Weymouth, Massachusetts, United States

Neuro Eye Clinical Trials; 🇺🇸 Houston, Texas, United States