Thyroid Eye DiseasePhase 3STRIVENCT06384547
A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
A Phase 3 study testing Veligrotug in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 50 sites in 7 countries.
Trial summary
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Veligrotug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 50 sitesin 7 countries
- Study dates
- 23 May 2024to 19 Jan 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment
- Must agree to use highly effective contraception method as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
- Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
Who cannot join
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1
- Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
- Must not have received any other therapy for TED within 8 weeks prior to Day 1
- Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
- Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
Show all 10Show fewer
- Must not have had previous orbital irradiation or decompression surgery involving excision of fat for TED in the study eye's orbit
- Must not have inflammatory bowel disease
- Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor.
- Female TED participants must not be pregnant or lactating.
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
United States26 sites
University of Colorado - Dept of Ophthalmology
Aurora, Colorado, 80045
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
University of Vermont Medical Center
Burlington, Vermont, 05401
Fraser Eye Care Center
Fraser, Michigan, 48026
Sina Medical Center LLC
Homestead, Florida, 33034
Baylor College of Medicine (BCM) - Ophthalmology
Houston, Texas, 77030
Neuro-Eye Clinical Trials
Houston, Texas, 77074
Neuro-Ophthalmology of Texas, PLLC
Houston, Texas, 77074
United Medical Research Institute
Inglewood, California, 90301
University Health Diabetes, Endocrinology & Nephrology Center
Kansas City, Kansas, 64108
KU Medical Center, University of Kansas
Kansas City, Kansas, 66103
Advancing Research International, LLC
Las Vegas, Nevada, 89144
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152
Advancing Research International, LLC
Los Angeles, California, 90023
Med-Care Research Inc.
Miami, Florida, 33125
University of Minnesota, Department of Ophthalmology and Visual Neurosciences
Minneapolis, Minnesota, 55455
West Virginia University Eye Institute
Morgantown, West Virginia, 26506
New York Eye Ear Infirmary of Mount Sinai
New York, New York, 10003
Rutgers- New Jersey Medical School- Newark
Newark, New Jersey, 07103
Vision Medical Research Inc.
Orland Park, Illinois, 60462
Stanford Byers Eye Institute
Palo Alto, California, 94303
Edward Jenner Research Group Center LLC
Plantation, Florida, 33317
Cockerham Eye Consultants, PC
San Diego, California, 92108
FOMAT Medical Research
Santa Maria, California, 93454
Sarasota Retina Institute
Sarasota, Florida, 34231
Ophthalmic Consultants of Boston
Weymouth, Massachusetts, 02189
Spain8 sites
Clinica Bonanova de Cirugia Ocular
Barcelona, 08022
Hospital Arruzafa
Córdoba, 14012
Clínica Universidad de Navarra
Madrid, 28027
Hospital Universitario Ramón y Cajal
Madrid, 28034
Clinica Universidad de Navarra
Pamplona, 31008
Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
Santiago de Compostela, A Coruña, 15706
Hospital Universitario Virgen De La Macarena, Servicio de Oftalmología
Seville, 41071
Miguel Servet University Hospital, Clinical Trials Unit
Zaragoza, 50009
Poland5 sites
NZOZ E-Vita
Bialystok, 15-879
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, 85-870
Santa Familia PTG Lodz
Lódz, 90-302
Panstwowy Instytut Medyczny MSWiA
Warsaw, 02-507
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Wroclaw, 53-114
France4 sites
CHU d'Angers
Angers, 49100
Centre Hospitalier National D'ophtalmologie
Des Quinze Vingts Paris, 75012
CH Nice
Nice, 06000
AP-HP - Hôpital de la Pitié Salpétrière
Paris, 75013
United Kingdom3 sites
Northwick Park Hospital
London, HA1 3UJ
Western Eye Hospital, Imperial College NHS Trust
London, NW1 5QH
Guy's and St. Thomas NHS Trust
London, SE1 7EH
Australia2 sites
Sydney Eye Hospital
Sydney, 2000
North Shore Eye Surgery
Sydney, 2065
Germany2 sites
Universitätsmedizin Göttingen
Göttingen, 37075
Johannes Gutenberg-University Medical Center
Mainz, 55131
About this study
Official title: A Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Thyroid Eye Disease (TED)
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.
- Conditions
- Thyroid Eye Disease
- Being tested
- Veligrotug
- Keywords
- Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy, Thyroid-Associated Orbitopathy, Graves Disease, Graves Eye Disease, Graves Orbitopathy
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeligrotugDrug
Also called VRDN-001
5 infusions of veligrotug
| Study group | Role | What they receive |
|---|---|---|
| Veligrotug 10 mg/kg | Experimental | Participants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks. Receives: Drug: Veligrotug |
| Veligrotug 3 mg/kg | Experimental | Participants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks. Receives: Drug: Veligrotug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline through Week 15
Secondary outcomes (2)
Change From Baseline in Proptosis in the Study Eye as Measured by Exophthalmometer
Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in millimeters (mm), measured using an exophthalmometer. Observed change from baseline in proptosis in study eye is reported. Missing data were not imputed.
Measured: Baseline, Week 15
Number of Participants With TEAEs Through Week 52
An AE was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start23 May 2024
- Primary completion1 May 2025
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid Eye DiseaseStudies 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
- A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 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
- NCT06384547
- Sponsor's protocol ID
- VRDN-001-303
- Acronym
- STRIVE
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2024
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT06384547
- Acronym / sponsor ID
- STRIVE / VRDN-001-303
- Conditions
- Thyroid Eye Disease
- Keywords
- Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy, Thyroid-Associated Orbitopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Viridian Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).
| Arm | Type | Receives |
|---|---|---|
| Veligrotug 10 mg/kg | Experimental | Drug: VeligrotugParticipants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks. |
| Veligrotug 3 mg/kg | Experimental | Drug: VeligrotugParticipants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks. |
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 clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment
- Must agree to use highly effective contraception method as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
- Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
Key exclusion criteria (10 listed)
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1
- Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
- Must not have received any other therapy for TED within 8 weeks prior to Day 1
- Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
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 |
|---|---|---|
| VeligrotugAlso: VRDN-0015 infusions of veligrotug | Drug | Veligrotug 10 mg/kg, Veligrotug 3 mg/kg |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15
Time frame: Baseline through Week 15
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
2 secondary outcomes
Change From Baseline in Proptosis in the Study Eye as Measured by Exophthalmometer
Time frame: Baseline, Week 15
Number of Participants With TEAEs Through Week 52
Time frame: Baseline through Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
50 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 Veligrotug in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 50 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: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Spain, Poland, France, United Kingdom 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?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15 (time frame: Baseline through Week 15). 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 13 Aug 2026.