Not yet taking people in United StatesPhase 4
An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab
Key facts
- Who runs it
- Viridian Therapeutics, Inc.
- Where
- East Weymouth, Houston, Kansas City, Livonia, Newport Beach, Sarasota, and Somerset, United StatesSee the 8 sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 30 people, planned
- Started
- Sept 2026
- Expected to end
- Sept 2027
- Type of study
- Interventional
- Treatments tested
- veligrotrug (LUMVOA™)
- Record updated
- 21 September 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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 take part
- 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
- Must not have sight-threatening TED (eg, dysthyroid optic neuropathy)
- Female participants must not be pregnant or breastfeeding
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- Ophthalmic Consultants of BostonEast Weymouth, United StatesContact: Study CoordinatorNo longer taking part
- Baylor College of Medicine, Alkek Eye CenterHouston, United StatesContact: Study CoordinatorNo longer taking part
- Neuro-Eye Clinical TrialsHouston, United StatesContact: Study CoordinatorNo longer taking part
- University HealthKansas City, United StatesContact: Study CoordinatorNo longer taking part
- Kahana Oculoplastic & Orbital SurgeryLivonia, United StatesContact: Study CoordinatorNo longer taking part
- Office of Dr. Amy Patel Jain, MDNewport Beach, United StatesContact: Study CoordinatorNo longer taking part
- Sarasota Retina InstituteSarasota, United StatesContact: Study CoordinatorNo longer taking part
- The Center for Eye and Facial Plastic SurgerySomerset, United StatesContact: Study CoordinatorNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- 5 IV infusions of 10 mg/kg of veligrotugTreatment being tested
Participants will receive veligrotug10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.
Treatment: veligrotrug (LUMVOA™)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Fit questions
- Built from NCT07832136, who can take part
- Record updated
- 21 September 2026