A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Have a clinical diagnosis of TED with or without proptosis, 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
Locations
United States
California
United Medical Research Institute
RECRUITING
Inglewood
Florida
Ilumina Medical Research
RECRUITING
Kissimmee
Hype Clinical Research, LLC
RECRUITING
Miami
Michigan
Fraser Eye Center
RECRUITING
Fraser
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 75
Treatments
Experimental: VRDN-003 every 4 weeks using autoinjector
6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\]
Experimental: VRDN-003 every 8 weeks using autoinjector
3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]
Experimental: VRDN-003 every 8 weeks using vial and syringe
3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]
Related Therapeutic Areas
Sponsors
Leads: Viridian Therapeutics, Inc.