Trials Today

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

Purpose

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

Condition

Thyroid Eye Disease (TED)

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of the two study arms.
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will be randomized to one of the two study arms

Arm Groups

Arm	Description	Assigned Intervention
Experimental VRDN-003 every 4 weeks	6 subcutaneous administrations of VRDN-003	Drug: VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Experimental VRDN-003 every 8 weeks	3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo	Drug: VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). Drug: Placebo Placebo injections that appear identical to VRDN-003 injections but have no active drug.

Recruiting Locations

Catalina Eye Care
Tuscon, Arizona 85712

United Medical Research Institute
Inglewood, California 90301

California Eye Specialists Medical Group INC
Pasadena, California 91107

FOMAT Medical Research
Santa Maria, California 93454

C A Clinical Trial Corp.
Cape Coral, Florida 33990

Herco Medical and Research Center
Coral Gables, Florida 33134

D H Doral Research Center
Doral, Florida 33122

Sina Medical Center
Homestead, Florida 33034

East Coast Institute for Research, LLC
Jacksonville, Florida 32216

Southern Clinical Research LLC
Miami, Florida 33125

Retreat Medical Research
Miami, Florida 33135

Continental Clinical Research
Miami, Florida 33144

Edward Jenner Research Group LLC
Plantation, Florida 33317

Ophthalmic Consultants of Boston
East Weymouth, Massachusetts 02189

DFW Clinical Trials
Carrollton, Texas 75010

Neuro Eye Clinical Trials
Houston, Texas 77074

Pioneer Research Solutions Inc.
Houston, Texas 77099

Elevate Clinical Research
Seabrook, Texas 77586

More Details

NCT ID: NCT06812325
Status: Recruiting
Sponsor: Viridian Therapeutics, Inc.

Study Contact

Stephen Director, Clinical Operations
551-265-2151
sgust@viridiantherapeutic.com

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.