Thyroid Eye DiseasePhase 3REVEAL-2NCT06625398
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
A Phase 3 study testing VRDN-003 in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 60 sites in 6 countries.
Trial summary
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic 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
- 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
- 204 participants
- Where
- 60 sitesin 6 countries
- Study dates
- 27 Aug 2024to 15 Dec 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
- Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
- 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 11Show 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
- NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.
Trial locations and contacts
60 sites in 6 countries.
60 sites in 6 countries
United States37 sites
Asheville Clinical Research
Asheville, North Carolina, 28803
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Alliance Research Institute - Canoga Park
Canoga Park, California, 91304
Horizon Clinical Research Group
Cypress, Texas, 77429
Duke Eye Center
Durham, North Carolina, 27710
Opthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189
Fraser Eye Care Center
Fraser, Michigan, 48026
Baylor College of Medicine/Alkek Eye Center
Houston, Texas, 77030
Gulf Coast Clinical Trials
Houston, Texas, 77070
Neuro-Eye Clinical Trials
Houston, Texas, 77074
Marvel Clinical Research
Huntington Beach, California, 92647
United Medical Research Institute
Inglewood, California, 90301
University Health
Kansas City, Missouri, 64108
Ilumina Medical Research
Kissimmee, Florida, 34744
S.L. Office
Las Vegas, Nevada, 89144
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152
Advancing Research International, LLC
Los Angeles, California, 90023
Roski Eye Institute, Keck School of Medicine, USC
Los Angeles, California, 90033
Alliance Research Institute - Lynwood
Lynwood, California, 90262
Med-Care Research
Miami, Florida, 33125
Hype Clinical Research LLC
Miami, Florida, 33145
Anmed Health Services LLC
Miami, Florida, 33193
Southern Clinical Research LLc
Miami, Florida, 33990
West Virginia University Eye Institute
Morgantown, West Virginia, 26506
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
A.P.J. Office
Newport Beach, California, 92660
Vision Medical Research
Orland Park, Illinois, 60462
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Pasadena Clinical Trials
Pasadena, California, 91101
Scheie Eye Institute Penn Presbyterian
Philadelphia, Pennsylvania, 19104
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Cockerham Eye Consultants, PC
San Diego, California, 92108
Sarasota Retina Institute
Sarasota, Florida, 34239
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
University of Washington, Eye institute
Seattle, Washington, 98104
Vector Clinical Trials
Sparks, Nevada, 89436
Poland7 sites
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
Santa Familia PTG Lodz
Lodz, 90-302
ETG Lublin
Lublin, 20-412
Eskulap Pabianice Sp. z o.o.
Pabianice, 95-200
Centrum Medyczne Pulawska Sp. z o.o.
Piaseczno, 05 500
Warszawski Szpital Okulistyczny
Warsaw, 01-258
Polimedica PTG
Warsaw, 02-793
Spain6 sites
Hospital Arruzafa / Metavisión Arruzafa, S.L
Córdoba, 14012
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos de Madrid
Madrid, 28043
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, A Coruña, 15706
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Miguel Servet
Zaragoza, 50009
Germany4 sites
Charité Universitätsmedizin Berlin KöR
Berlin, 13353
Universitätsklinikum Carl- Gustav- Carus- Dresden
Dresden, 1307
Klinikapotheke des Universitätsklinikums Gießen und Marburg GmbH (UKGM)
Giessen, 35392
Universitätsmedizin Göttingen
Göttingen, 37075
Hungary4 sites
Ganglion Orvosi Kozpont - Nozologen Kft - Szemeszet
Budapest, 1133
Pecsi Tudomanyegyetem Klinikai Kozpont, Szemeszeti Klinika
Pécs, 7623
Ganglion Orvosi Kozpont - Nozologen Kft - Szemeszet
Pécs, H-7621
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz, Szemeszeti Osztaly
Szombathely, 9700
Netherlands2 sites
Amsterdam UMC
Amsterdam, 1081 HZ
Erasmus Medical Center
Rotterdam, 3015
About this study
Official title: REVEAL-2 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic 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), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as subcutaneous/SC injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic TED.
Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.
- Conditions
- Thyroid Eye Disease
- Being tested
- VRDN-003, Placebo
- Keywords
- TED, Thyroid Eye Disease, Graves, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic 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
All participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections.
| 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 |
| Placebo every 4 weeks | Placebo comparator | 6 subcutaneous administrations of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title: Proptosis Responder Rate in the most proptotic eye as measured by exophtalmometer
Description: Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophtalmometer [without a corresponding increase of ≥2 mm in the other eye]
Measured: At Week 24
Secondary outcomes (6)
Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer
Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer
Measured: At Week 24
Proptosis Responder Rate in the most proptotic eye as measured by MRI
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by MRI [without a corresponding increase of ≥2 mm in the other eye]
Measured: At Week 24
Change from baseline in proptosis in the most proptotic eye as measured by MRI
Change from baseline in proptosis in the most proptotic eye as measured by MRI
Measured: At Week 24
Overall Responder Rate in the most proptotic eye as measured by exophthalmometer
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophthalmometer [without a corresponding increase of ≥2 mm in the other eye] AND no worsening in Clinical Activity Score (CAS) from baseline in the most proptotic eye [without a corresponding increase of ≥2 points in the other eye]
Measured: At Week 24
Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0
Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0)
Measured: At Week 24
Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0
Proportion of participants with a reduction in Diplopia Score to 0 from baseline (for participants with baseline Diplopia Score greater than 0)
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start27 Aug 2024
- Primary completion4 Mar 2026
- Study completion15 Dec 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 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
- Participants will be randomized to one of the three study arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 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
- NCT06625398
- Sponsor's protocol ID
- VRDN-003-302
- Acronym
- REVEAL-2
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2024
- Last updated
- 18 Aug 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVEAL-2 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT06625398
- Acronym / sponsor ID
- REVEAL-2 / VRDN-003-302
- Conditions
- Thyroid Eye Disease
- Keywords
- TED, Thyroid Eye Disease, Graves, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Viridian Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 3 Oct 2024 (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 efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic 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), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as subcutaneous/SC injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic TED.
Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to one of the three 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 |
| Placebo every 4 weeks | Placebo comparator | Drug: Placebo6 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 (3 listed)
- Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
- 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 (11 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 |
| PlaceboAll participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections. | Drug | Placebo every 4 weeks, VRDN-003 every 8 weeks |
Primary outcome
Title: Proptosis Responder Rate in the most proptotic eye as measured by exophtalmometer
Time frame: At Week 24
Description: Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophtalmometer [without a corresponding increase of ≥2 mm in the other eye]
6 secondary outcomes
Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer
Time frame: At Week 24
Proptosis Responder Rate in the most proptotic eye as measured by MRI
Time frame: At Week 24
Change from baseline in proptosis in the most proptotic eye as measured by MRI
Time frame: At Week 24
Overall Responder Rate in the most proptotic eye as measured by exophthalmometer
Time frame: At Week 24
Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0
Time frame: At Week 24
Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0
Time frame: At Week 24
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 18 Aug 2026.
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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.
60 sites in 6 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, run by Viridian Therapeutics, Inc. at 60 sites in 6 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 3 inclusion and 11 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 18 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 60 sites in United States, Poland, Spain, Germany, Hungary and 1 more country. 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. Some participants in this study may receive a placebo. 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?
Title: Proptosis Responder Rate in the most proptotic eye as measured by exophtalmometer (time frame: At 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 18 Aug 2026.