Thyroid Eye Disease (TED)Phase 3NCT06812325
A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
A Phase 3 study testing VRDN-003 in people with Thyroid Eye Disease (TED), run by Viridian Therapeutics, Inc. at 64 sites in 7 countries.
Trial summary
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease (TED)
- What is being tested?
- VRDN-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 64 sitesin 7 countries
- Study dates
- 3 Feb 2025to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
64 sites in 7 countries.
64 sites in 7 countries
United States32 sites
C A Clinical Trial Corp.
Cape Coral, Florida, 33990
DFW Clinical Trials
Carrollton, Texas, 75010
Herco Medical and Research Center
Coral Gables, Florida, 33134
Alfa Medical Research
Davie, Florida, 33024
D H Doral Research Center
Doral, Florida, 33132
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189
Eye Centers of Florida
Fort Myers, Florida, 33901
Fraser Eye Care Center
Fraser, Michigan, 48026
Sina Medical Center
Homestead, Florida, 33034
Neuro Eye Clinical Trials
Houston, Texas, 77074
Pioneer Research Solutions Inc.
Houston, Texas, 77099
United Medical Research Institute
Inglewood, California, 90301
Jackson Clinic
Jackson, Tennessee, 38305
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
University of Missouri Kansas City
Kansas City, Missouri, 64108
Southern Clinical Research LLC
Miami, Florida, 33125
Retreat Medical Research
Miami, Florida, 33135
Continental Clinical Research
Miami, Florida, 33144
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Orbital Plastics
Newport Beach, California, 92660
Advanced Quality Medical Research
Orland Park, Illinois, 60462
California Eye Specialists Medical Group INC
Pasadena, California, 91107
FOMAT Medical Research
Pismo Beach, California, 93030
Edward Jenner Research Group LLC
Plantation, Florida, 33317
Mayo Clinic Rochester
Rochester, Minnesota, 55905
San Antonio Clinical Trials
San Antonio, Texas, 78240
Eyeplastx
San Antonio, Texas, 78258
Pacific Neuroscience Institute
Santa Monica, California, 90404
Sarasota Retina Institute
Sarasota, Florida, 34239
Elevate Clinical Research
Seabrook, Texas, 77586
Pacific Neuroscience Institute at Saint John's Physician Partners
Torrance, California, 90503
Catalina Eye Care
Tuscon, Arizona, 85712
Poland8 sites
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Okulistyki, Centrum Badań Klinicznych
Bialystok, 15-276
Optimum Profesorskie Centrum Okulistyki Sp. z o. o.
Gdansk, 80-180
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
Santa Familia PTG Lodz
Lodz, 90-302
ETG Lublin
Lublin, 20-412
Centrum Medyczne Pulawska Sp. z o.o.
Piaseczno, 05-500
Warszawski Szpital Okulistyczny
Warsaw, 01-258
Polimedica PTG
Warsaw, 02-777
Spain7 sites
Hospital Provincial de Conxo
A Coruña, 15706
Institut Català de Retina
Barcelona, 08017
Hospital La Arruzafa
Córdoba, 14012
Hospital Universitario Ramon y Cajal
Madrid, 28034
Clinica Universidad de Navarre
Navarrés
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Miguel Servet Consultas de Oftalmologia
Zaragoza
United Kingdom6 sites
University Hospitals Bristol and Weston NHS Foundation Trust Clinical Research Unit
Bristol
Addenbrookes Hospital
Cambridge
Imperial College Healthcare NHS Trust
London, NW1 5QH
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Moorefields Eye Hospital NHS Foundation Trust
London
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle
Germany4 sites
Charite Universitatsmeizin Berlin KoR Campus Virchow Klinikum
Berlin
Universitatsklinikum Essen
Essen
Universitaetsmedizin Goettingen
Göttingen, 37075
Johannes Gutenberg University Medical Center Department of Medicine 1
Mainz
Turkey (Türkiye)4 sites
Gazi University Medical Faculty Hospital
Ankara
Hacettepe Univeristy Medical Fculty Hospital
Ankara
Akdeniz Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı
Antalya, 07059
Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi Göz Hastalıkları Kliniği
Istanbul
France3 sites
Servicde d'Endocrinologie, Diabetologieet Nutrition Centre Hospitalier Universitaire d'Angers
Angers
Abeillon du Payrat
Bron, 69500
Hôpital La Pitiélsalpêtrière
Paris
About this study
Official title: A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).
Read the 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.
- Conditions
- Thyroid Eye Disease (TED)
- Being tested
- VRDN-003, Placebo
- Keywords
- Graves, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRDN-003Drug
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
PlaceboDrug
Placebo injections that appear identical to VRDN-003 injections but have no active drug.
| Study group | Role | What they receive |
|---|---|---|
| VRDN-003 every 4 weeks | Experimental | 6 subcutaneous administrations of VRDN-003 Receives: Drug: VRDN-003 |
| VRDN-003 every 8 weeks | Experimental | 3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo Receives: Drug: VRDN-003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Measured: Week 24
Secondary outcomes (2)
Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer
Change from baseline in proptosis in the study eye
Measured: Week 24
TEAE incident rate through study completion
Treatment Emergent Adverse Event (TEAE) incidence rate measurement through study completion
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start3 Feb 2025
- Primary completion22 Apr 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease (TED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of the two study arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viridian Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812325
- Sponsor's protocol ID
- VRDN-003-303
- Status last verified
- May 2026
- First submitted
- 27 Jan 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT06812325
- Acronym / sponsor ID
- VRDN-003-303
- Conditions
- Thyroid Eye Disease (TED)
- Keywords
- Graves, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Viridian Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of the two study arms.
| Arm | Type | Receives |
|---|---|---|
| VRDN-003 every 4 weeks | Experimental | Drug: VRDN-0036 subcutaneous administrations of VRDN-003 |
| VRDN-003 every 8 weeks | Experimental | Drug: VRDN-003, Drug: Placebo3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRDN-003VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). | Drug | VRDN-003 every 4 weeks, VRDN-003 every 8 weeks |
| PlaceboPlacebo injections that appear identical to VRDN-003 injections but have no active drug. | Drug | VRDN-003 every 8 weeks |
Primary outcome
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Time frame: Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
2 secondary outcomes
Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer
Time frame: Week 24
TEAE incident rate through study completion
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Related trials for Thyroid Eye Disease (TED)
RecruitingObservational study
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Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
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Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
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RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
64 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VRDN-003 in people with Thyroid Eye Disease (TED), run by Viridian Therapeutics, Inc. at 64 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Poland, Spain, United Kingdom, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.