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Clinical Trial NCT07155668 for Thyroid Eye Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Recruiting
Clinical Trial NCT07155668 is designed to study Treatment for Thyroid Eye Disease. It is a Phase 3 interventional trial that is recruiting, having started on July 1, 2025, with plans to enroll 75 participants. Led by Viridian Therapeutics, Inc., it is expected to complete by November 1, 2026. The latest data from ClinicalTrials.gov was last updated on September 4, 2025.
Brief 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)
Detailed Description
This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.
Official Title

A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)

Conditions
Thyroid Eye Disease
Other Study IDs
  • VRDN-003-304
NCT ID Number
NCT07155668
Start Date (Actual)
2025-07-01
Last Update Posted
2025-09-04
Completion Date (Estimated)
2026-11
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalVRDN-003 every 4 weeks using autoinjector
6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\]
VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Autoinjector
The autoinjector is a single-dose, disposable, ready-to-use delivery device
ExperimentalVRDN-003 every 8 weeks using autoinjector
3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]
VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Autoinjector
The autoinjector is a single-dose, disposable, ready-to-use delivery device
ExperimentalVRDN-003 every 8 weeks using vial and syringe
3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]
VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Treatment Emergent Adverse Event (TEAE) incidence rate
Treatment Emergent Adverse Event (TEAE) incidence rate
Through Week 24
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pharmacokinetic outcome measures
Time of maximum serum concentration (Tmax) of VRDN-003
Through Week 24
Pharmacokinetic outcome measures
Maximum serum concentration (Cmax) of VRDN-003
Through Week 24
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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 12 weeks prior to first dose
  • Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 or 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
Viridian Therapeutics, Inc. logoViridian Therapeutics, Inc.5 active trials to explore
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4 Study Locations in 1 Countries

California

United Medical Research Institute, Inglewood, California, 90301, United States
Study Coordinator, Contact, 310-645-4673, [email protected]
Recruiting

Florida

Ilumina Medical Research, Kissimmee, Florida, 34744, United States
Study Coordinator, Contact, 407-807-6506, [email protected]
Recruiting
Hype Clinical Research, LLC, Miami, Florida, 33145, United States
Study Coordinator, Contact, 305-833-0053, [email protected]
Recruiting

Michigan

Fraser Eye Center, Fraser, Michigan, 48026, United States
Study Coordinator, Contact, 586-296-7250, [email protected]
Recruiting