Thyroid Eye Disease (TED)
Conditions
Keywords
Graves, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy
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.
Interventions
DRUGVRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
DRUGPlacebo
Placebo injections that appear identical to VRDN-003 injections but have no active drug.
Sponsors
Viridian Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participant, Site personnel (except pharmacy personnel preparing the injection), and Sponsor are masked.
Intervention model description
Participants will be randomized to one of the two study arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key 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 Key
Exclusion criteria
* Must not have received prior treatment with another anti-IGF-1R therapy * Must not have received systemic corticosteroids or steroid eye drops 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 for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24 | Week 24 | Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France, Germany, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed