Can a new antibody help when thyroid eye disease comes back?
NCT ID NCT07832136
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing veligrotug, an intravenous antibody, in adults with moderate to severe thyroid eye disease that returned after they responded to teprotumumab. The trial enrolls about 30 participants who completed a full course of teprotumumab at least nine months earlier and then had a recurrence. Everyone receives veligrotug, and the main goal is to track side effects and see how well the drug controls the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- veligrotug, an experimental antibody given as an intravenous infusion
- What this could lead to
- If it works, veligrotug could offer a repeat treatment option for people whose thyroid eye disease returns after teprotumumab.
- What could go wrong
- This is a small, single-arm phase 4 trial with no comparison group, so results may not show whether veligrotug truly helps. Infusions can cause reactions, and the drug's safety profile is still being characterized.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 contraception 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 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine Alkek Eye Center
Houston, Texas, 77030, United States
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Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152, United States
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Neuro-Eye Clinical Trials
Houston, Texas, 34239, United States
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Office of Dr. Amy Patel Jain, MD
Newport Beach, California, 92660, United States
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Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189, United States
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Sarasota Retina Institute
Sarasota, Florida, 34239, United States
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The Center for Eye and Facial Plastic Surgery
Somerset, New Jersey, 08873, United States
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University Health
Kansas City, Missouri, 64108, United States
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