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Thyroid Eye DiseasePhase 3REVEAL-1NCT06625411

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)

A Phase 3 study testing VRDN-003 in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 48 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active 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
132 participants
Where
48 sitesin 5 countries
Study dates
27 Aug 2024to 15 Nov 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 active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
  • Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
  • 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 who 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

48 sites in 5 countries.

48 sites in 5 countries

United States34 sites

  • Asheville Clinical Research

    Asheville, North Carolina, 28803

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

  • Alliance Research Institute - Canoga Park

    Canoga Park, California, 91304

  • C&A Clinical Trials Corp

    Cape Coral, Florida, 33990

  • Duke Eye Center

    Durham, North Carolina, 27705

  • 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

  • Continental Clinical Research

    Miami, Florida, 33144

  • Hype Clinical Research LLC

    Miami, Florida, 33145

  • Anmed Health Services LLC

    Miami, Florida, 33193

  • 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

  • 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

Other trials in United States

Spain6 sites

  • Hospital Arruzafa / Metavisión Arruzafa, S.L

    Córdoba, 14012

  • Hospital Clínico San Carlos

    Córdoba, 14012

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

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

  • Universitaetsmedizin Goettingen

    Göttingen, 37075

Other trials in Germany

Hungary2 sites

  • Budapest Retina Intezet

    Budapest, 1133

  • Pecsi Tudomanyegyetem Klinikai Kozpont, Szemeszeti Klinika

    Pécs, 7623

Other trials in Hungary

Netherlands2 sites

  • Amsterdam UMC

    Amsterdam, 1081 HZ

  • Erasmus Medical Center

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

Official title: REVEAL-1 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active 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 active TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/SC injections given every 4 weeks or every 8 weeks compared to placebo in participants with active 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.

Being tested
VRDN-003, Placebo
Keywords
TED, Thyroid Eye Disease, Graves, 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

    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 groups in NCT06625411
Study groupRoleWhat they receive
VRDN-003 every 4 weeksExperimental6 subcutaneous administrations of VRDN-003
Receives: Drug: VRDN-003
VRDN-003 every 8 weeksExperimental3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Receives: Drug: VRDN-003; Drug: Placebo
Placebo every 4 weeksPlacebo comparator6 subcutaneous administrations of placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proptosis Responder Rate in the most proptotic eye as measured by exophtalmometer

    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 (9)

  1. 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

  2. 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

  3. 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

  4. 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 ≥ 2 points reduction in Clinical Activity Score (CAS) from baseline in the most proptotic eye as measured by exophthalmometer [without a corresponding increase of ≥2 points in the other eye]

    Measured: At Week 24

  5. Change from baseline in Clinical Activity Score (CAS) in the most proptotic eye (as measured by exophthalmometer)

    Change from baseline in Clinical Activity Score (CAS) in the most proptotic eye (as measured by exophthalmometer) [range, 0 to 7, with higher scores indicating greater level of inflammation]

    Measured: At Week 24

  6. Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the most proptotic eye (as measured by exophthalmometer)

    Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the most proptotic eye (as measured by exophthalmometer)

    Measured: At Week 24

  7. 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

  8. 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

  9. Clinical Activity Responder Rate in the most proptotic eye (as measured by exophthalmometer)

    Proportion of participants with a ≥ 2 points reduction in CAS from baseline in the most proptotic eye as measured by exophthalmometer [without a corresponding increase of ≥2 points in the other eye]

    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.

  1. First posted3 Oct 2024
  2. Study start27 Aug 2024
  3. Primary completion12 Feb 2026
  4. Study completion15 Nov 2026 (estimated)

Resources

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
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625411
Sponsor's protocol ID
VRDN-003-301
Acronym
REVEAL-1
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

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 48 sites in 5 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 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 48 sites in United States, Spain, Germany, Hungary, Netherlands. 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?

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?

On the ClinicalTrials.gov record for NCT06625411.

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.

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