An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants with Chronic Thyroid Eye Disease (TED) (THRIVE-2)

Viridian Therapeutics

Status and phase

Active, not recruiting

Phase 3

Conditions

Thyroid Eye Disease

Treatments

Drug: Veligrotug (VRDN-001)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06021054

VRDN-001-301

Details and patient eligibility

About

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).

Full description

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if veligrotug (VRDN-001) is efficacious, safe, and tolerable when administered as 5 IV infusions given every 3 weeks for a total of 12 weeks in participants with chronic TED

Enrollment

188 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
Must have had a clinical diagnosis of TED, with any CAS (0-7)
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 received prior treatment with another anti-IGF-1R therapy
Must not have received systemic corticosteroids for any condition, including TED within 2 weeks prior to first dose
Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks prior to first dose
Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results
Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
Must not have a history of inflammatory bowel disease
Must not have an abnormal hearing test before first dose or history of ear conditions considered clinically significant by the study doctor
Female TED participants must not be pregnant or lactating