A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (STRIVE)

Viridian Therapeutics

Status and phase: Completed; Phase 3

Conditions: Thyroid Eye Disease

Treatments: Drug: Veligrotug

Study type: Interventional

Funder types: Industry

Identifiers

NCT06384547

VRDN-001-303

Details and patient eligibility

About

The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.

Enrollment: 231 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of TED with or without proptosis and with any clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment
• Must agree to use highly effective contraception method as specified in the protocol
• Female TED participants must have a negative serum pregnancy test at screening
• Not require immediate ophthalmological or orbital surgery in the study eye for any reason.

Exclusion criteria

• Must not have received prior treatment with another anti-IGF-1R therapy
• Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1
• Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
• Must not have received any other therapy for TED within 8 weeks prior to Day 1
• Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
• Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
• Must not have had previous orbital irradiation or decompression surgery involving excision of fat for TED in the study eye's orbit
• Must not have inflammatory bowel disease
• Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor.
• Female TED participants must not be pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 2 patient groups

Veligrotug 10 mg/kg

Experimental group

Description:

Participants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks.

Treatment:

Drug: Veligrotug

Veligrotug 3 mg/kg

Experimental group

Description:

Participants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks.

Treatment:

Drug: Veligrotug