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

Viridian Therapeutics

Status and phase

Active, not recruiting

Phase 3

Conditions

Thyroid Eye Disease

Treatments

Drug: VRDN-001 10 mg/kg

Drug: VRDN-001 3 mg/kg

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 patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.

Full description

A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (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 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
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.
Must not have received an investigational agent for any condition within 8 weeks prior to Day 1
Female TED participants must not be pregnant or lactating