Thyroid Eye DiseasePhase 3NCT07155668
A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
A Phase 3 study testing VRDN-003 and Autoinjector in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 13 sites in United States.
Trial summary
This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease) 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 and Autoinjector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Jul 2025to 28 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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, 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 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/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 or 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
13 sites in 1 country.
13 sites in 1 country
United States13 sites
C&A Clinical Trials Corp
Cape Coral, Florida, 33990
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189
Fraser Eye Center
Fraser, Michigan, 48026
Baylor College of Medicine, Alkek Eye Center
Houston, Texas, 77030
Neuro Eye Clinical Trials INC
Houston, Texas, 77074
United Medical Research Institute
Inglewood, California, 90301
Ilumina Medical Research
Kissimmee, Florida, 34744
Kahana Oculoplastic and Orbital Surgery
Livonia, Michigan, 48152
Med-Care Research
Miami, Florida, 33125
Continental Clinical Research, llc
Miami, Florida, 33144
Hype Clinical Research, LLC
Miami, Florida, 33145
Advanced Quality Medical Research, LLC
Orland Park, Illinois, 60462
Vector Clinical Trials
Sparks, Nevada, 89128
About this study
Official title: A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)
This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)
Read the detailed description
This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.
- Conditions
- Thyroid Eye Disease
- Being tested
- VRDN-003, Autoinjector
- 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).
AutoinjectorDevice
The autoinjector is a single-dose, disposable, ready-to-use delivery device
| Study group | Role | What they receive |
|---|---|---|
| VRDN-003 every 4 weeks using autoinjector | Experimental | 6 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 5 doses of 300mg] Receives: Drug: VRDN-003; Device: Autoinjector |
| VRDN-003 every 8 weeks using autoinjector | Experimental | 3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg] Receives: Drug: VRDN-003; Device: Autoinjector |
| VRDN-003 every 8 weeks using vial and syringe | Experimental | 3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg] Receives: Drug: VRDN-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Event (TEAE) incidence rate
Treatment Emergent Adverse Event (TEAE) incidence rate
Measured: Through Week 24
Secondary outcomes (2)
Pharmacokinetic outcome measures
Time of maximum serum concentration (Tmax) of VRDN-003
Measured: Through Week 24
Pharmacokinetic outcome measures
Maximum serum concentration (Cmax) of VRDN-003
Measured: Through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Jul 2025
- Primary completion28 May 2026
- Study completion28 May 2026
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
- None (open label)
- Enrolment
- 87 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
- NCT07155668
- Sponsor's protocol ID
- VRDN-003-304
- Status last verified
- Dec 2025
- First submitted
- 7 Aug 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT07155668
- Acronym / sponsor ID
- VRDN-003-304
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Viridian Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 4 Sep 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, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)
Detailed description
This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 using autoinjector | Experimental | Drug: VRDN-003, Device: Autoinjector6 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 5 doses of 300mg] |
| VRDN-003 every 8 weeks using autoinjector | Experimental | Drug: VRDN-003, Device: Autoinjector3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg] |
| VRDN-003 every 8 weeks using vial and syringe | Experimental | Drug: VRDN-0033 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg] |
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, 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 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/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 using autoinjector, VRDN-003 every 8 weeks using autoinjector, VRDN-003 every 8 weeks using vial and syringe |
| AutoinjectorThe autoinjector is a single-dose, disposable, ready-to-use delivery device | Device | VRDN-003 every 4 weeks using autoinjector, VRDN-003 every 8 weeks using autoinjector |
Primary outcome
Treatment Emergent Adverse Event (TEAE) incidence rate
Time frame: Through Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate
2 secondary outcomes
Pharmacokinetic outcome measures
Time frame: Through Week 24
Pharmacokinetic outcome measures
Time frame: Through Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VRDN-003 and Autoinjector in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 13 sites in United States.
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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Through 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 25 Jun 2026.