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

NCT07832136 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: VRDN-001-401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Thyroid Eye Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of veligrotrug (LUMVOA™)

  Treatment Emergent Adverse Event (TEAE) incidence rate

  Through Week 15

Study Arms (1)

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.

Drug: veligrotrug (LUMVOA™)

Interventions

veligrotrug (LUMVOA™) DRUG

intravenous infusions

Also known as: veligrotug-vvze, VRDN-001

5 IV infusions of 10 mg/kg of veligrotug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viridian Therapeutics, Inc.: lead

Study Sites (8)

Office of Dr. Amy Patel Jain, MD

Newport Beach, California, 92660, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts, 02189, United States

Location

Kahana Oculoplastic & Orbital Surgery

Livonia, Michigan, 48152, United States

Location

University Health

Kansas City, Missouri, 64108, United States

Location

The Center for Eye and Facial Plastic Surgery

Somerset, New Jersey, 08873, United States

Location

Neuro-Eye Clinical Trials

Houston, Texas, 34239, United States

Location

Baylor College of Medicine Alkek Eye Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

James Sankan

CONTACT

781.204.8590; jsankan@viridiantherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (8)