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Completed

NCT Number: NCT06384547

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

North Shore Eye Surgery, Sydney, Australia

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VRDN-001 10 mg/kg

Drug

5 infusions of VRDN-001 10 mg/kg

VRDN-001 3 mg/kg

Drug

5 infusions of VRDN-001 3 mg/kg

Primary outcomes

  1. Treatment Emergent Adverse Event (TEAE) incidence rate

    Time frame: Week 15

Secondary outcomes

  1. Change from baseline in proptosis in the study eye as measured by exophthalmometer

    Time frame: Week 15

  2. Treatment Emergent Adverse Event (TEAE) incidence rate

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

Viridian Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Acronym: STRIVE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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