Thyroid Eye DiseasePhase 4NCT07832136
An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab
A Phase 4 study testing veligrotrug (LUMVOA™) in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 8 sites in United States.
Trial summary
This is a clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but subsequently had a disease recurrence. 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?
- veligrotrug (LUMVOA™)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 4
- 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 a diagnosis of TED with associated signs and symptoms.
- Must have completed an initial full course of treatment (8 infusions over approximately 21 weeks) with teprotumumab ≥9 months prior to screening.
- Must have a documented clinical response to teprotumumab.
- Must have evidence of recurrence following the completion of prior teprotumumab treatment course, as measured by exophthalmometer in the study eye.
- Must have a Clinical Activity Score (CAS) ≥3 in the study eye.
- Must not require immediate orbital surgery in the study eye during the anticipated duration of the trial.
- 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 sight-threatening TED (eg, dysthyroid optic neuropathy).
- Must not have received IGF-1R inhibitor therapy within 9 months prior to screening or received any IGF-1R inhibitor other than teprotumumab at any time.
- Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to the first dose.
- Must not have received other immunosuppressive drugs for any condition, including TED, within 12 weeks prior to the first dose or any other therapy for TED (except for artificial tears) within 8 weeks prior to the first dose.
- Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose.
- Must not have previous orbital irradiation or decompression surgery for TED to the study eye's orbit.
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- Must not have a pre-existing ophthalmic condition in the study eye which, in the study doctor's opinion, would interfere with interpretation of trial results.
- Must not have abnormal hearing test before first dose or any history of hearing impairment. Must not also have any history of ear conditions considered significant by the study doctor.
- Must not have a history of inflammatory bowel disease.
- Female participants must not be pregnant or breastfeeding.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189
Study Coordinator, 617-314-2732, mforsyth@eyeboston.com
Neuro-Eye Clinical Trials
Houston, Texas, 34239
Study Coordinator, 713-942-2187, mtavera@neuroeye.com
Baylor College of Medicine Alkek Eye Center
Houston, Texas, 77030
Study Coordinator, 941-921-5335, Isabella.valli@bcm.edu
University Health
Kansas City, Missouri, 64108
Study Coordinator, 816-218-2582, Bong.nguyen@umkc.edu
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152
Study Coordinator, 248-800-1180, kristin@mioculoplastics.com
Office of Dr. Amy Patel Jain, MD
Newport Beach, California, 92660
Study Coordinator, 248-800-1180, drjain@dramypateljain.com
Sarasota Retina Institute
Sarasota, Florida, 34239
Study Coordinator, 941-921-5335, peggy@sarasotaretinainstitute.com
The Center for Eye and Facial Plastic Surgery
Somerset, New Jersey, 08873
Study Coordinator, 609-798-7171, graciela@centerfacialplastics.com
About this study
Official title: A Phase 4, Single-Arm, Open-Label Trial to Evaluate the Safety and Efficacy of Veligrotug in Participants With Thyroid Eye Disease (TED) Who Previously Responded to Teprotumumab
This is a clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but subsequently had a disease recurrence.
Read the detailed description
This is a Phase 4, single-arm, open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to) clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab but subsequently had disease recurrence.
The primary objective of this trial is to evaluate the safety and tolerability of veligrotug when given as 5 intravenous (IV) infusions of 10 mg/kg administered every 3 weeks. To evaluate safety, the incidence rate of treatment-emergent adverse events (TEAEs) 3 weeks after the fifth infusion (ie, Week 15) will be determined.
- Conditions
- Thyroid Eye Disease
- Being tested
- veligrotrug (LUMVOA™)
- Keywords
- TED, Thyroid Eye Disease, Graves, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Thyroid-Associated 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.
veligrotrug (LUMVOA™)Drug
Also called veligrotug-vvze, VRDN-001
intravenous infusions
| Study group | Role | What they receive |
|---|---|---|
| 5 IV infusions of 10 mg/kg of veligrotug | Experimental | Participants will receive veligrotug10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks. Receives: Drug: veligrotrug (LUMVOA™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of veligrotrug (LUMVOA™)
Treatment Emergent Adverse Event (TEAE) incidence rate
Measured: Through Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viridian Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832136
- Sponsor's protocol ID
- VRDN-001-401
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single-Arm, Open-Label Trial to Evaluate the Safety and Efficacy of Veligrotug in Participants With Thyroid Eye Disease (TED) Who Previously Responded to Teprotumumab
- ClinicalTrials.gov ID
- NCT07832136
- Acronym / sponsor ID
- VRDN-001-401
- Conditions
- Thyroid Eye Disease
- Keywords
- TED, Thyroid Eye Disease, Graves, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Thyroid-Associated Ophthalmopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Viridian Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 Sep 2026 (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 to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but subsequently had a disease recurrence.
Detailed description
This is a Phase 4, single-arm, open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to) clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab but subsequently had disease recurrence.
The primary objective of this trial is to evaluate the safety and tolerability of veligrotug when given as 5 intravenous (IV) infusions of 10 mg/kg administered every 3 weeks. To evaluate safety, the incidence rate of treatment-emergent adverse events (TEAEs) 3 weeks after the fifth infusion (ie, Week 15) will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 IV infusions of 10 mg/kg of veligrotug | Experimental | Drug: veligrotrug (LUMVOA™)Participants will receive veligrotug10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) 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 (8 listed)
- Must have a diagnosis of TED with associated signs and symptoms.
- Must have completed an initial full course of treatment (8 infusions over approximately 21 weeks) with teprotumumab ≥9 months prior to screening.
- Must have a documented clinical response to teprotumumab.
- Must have evidence of recurrence following the completion of prior teprotumumab treatment course, as measured by exophthalmometer in the study eye.
- Must have a Clinical Activity Score (CAS) ≥3 in the study eye.
Key exclusion criteria (10 listed)
- Must not have sight-threatening TED (eg, dysthyroid optic neuropathy).
- Must not have received IGF-1R inhibitor therapy within 9 months prior to screening or received any IGF-1R inhibitor other than teprotumumab at any time.
- Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to the first dose.
- Must not have received other immunosuppressive drugs for any condition, including TED, within 12 weeks prior to the first dose or any other therapy for TED (except for artificial tears) within 8 weeks prior to the 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 |
|---|---|---|
| veligrotrug (LUMVOA™)Also: veligrotug-vvze, VRDN-001intravenous infusions | Drug | 5 IV infusions of 10 mg/kg of veligrotug |
Primary outcome
Safety and tolerability of veligrotrug (LUMVOA™)
Time frame: Through Week 15
Treatment Emergent Adverse Event (TEAE) incidence rate
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 21 Sep 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing veligrotrug (LUMVOA™) in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 8 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 8 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact James Sankan (781.204.8590, jsankan@viridiantherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of veligrotrug (LUMVOA™) (time frame: 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 21 Sep 2026.