ClinicalTrials.gg
Not yet recruitingNCT07832136Updated Sep 21, 2026

An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab

A Phase 4 interventional study of veligrotrug (LUMVOA™) in Thyroid Eye Disease, sponsored by Viridian Therapeutics, Inc.. Not yet recruiting at 8 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Viridian Therapeutics, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 53 studies in Graves Ophthalmopathy with a site in United States — 12 open to participants now, 18 under way, 8 of them phase 3. Graves Ophthalmopathy · United States.

Planned enrollment
36th of 47
30 · median 84
Started
2026
with 8 others
Phase 4
5 of 53
1 open now
Primary completion
2027-04
later than 8 of 17 live
Registered
52nd of 53
by date
Lead sponsor
9 of 53
Viridian Therapeutics, Inc.

Among the 53 studies in Graves Ophthalmopathy with a site in United States, this one is the 36th largest by planned enrollment of the 47 interventional ones, is one of 9 that started in 2026, is one of 5 in phase 4, reaches primary completion later than 8 of the 17 other live ones, and was the 52nd registered.

By phase

53 studies; the count open now beside each. This study's row is marked.

Phase 321 · 3 open
Phase 27 · 1 open
Phase 16 · 2 open
Observational5 · 3 open
Phase 4this study5 · 1 open
Phase 1/24 · 1 open
Phase 2/33 · 1 open
No phase1 · 0 open
Other kind1 · 0 open

By the year they started

First in 2006; this study’s year is marked. 9 started in 2026.

Size and results

Median enrollment 84 across the 47 interventional studies, 100 across the 5 observational. Of the 33 that completed or were terminated, 17 (52%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 53 studies in Graves Ophthalmopathy with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Thyroid Eye Disease

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Keywords

  • TED
  • Thyroid Eye Disease
  • Graves
  • Dysthyroid Ophthalmopathy
  • Graves Eye Disease
  • Graves Orbitopathy
  • Myopathic Ophthalmopathy
  • Thyroid-Associated Ophthalmopathy
  • Edematous Ophthalmopathy
  • Infiltrative Ophthalmopathy
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 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 as specified in the protocol.
  • Female TED participants must have a negative serum pregnancy test at screening.

Key Exclusion Criteria:

  • 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 or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to the first dose.
  • Must not have received other 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.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    5 IV infusions of 10 mg/kg of veligrotug

    Participants will receive veligrotug10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.

    Drug: veligrotrug (LUMVOA™)

Interventions

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of veligrotrug (LUMVOA™)

    Treatment Emergent Adverse Event (TEAE) incidence rate

    Time frame: Through Week 15

07

Study locations

8 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartEst.
Sep 2026
Primary completionEst.
Apr 2027
CompletionEst.
Sep 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07832136
Lead sponsor
Viridian Therapeutics, Inc.
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Sep 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

James Sankan
Contact
jsankan@viridiantherapeutics.com
781.204.8590

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: AVE1642

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