Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

An open-label study for participants who are non-responders at end of the treatment period assessment (i.e., 15 weeks) in the VRND-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies

Keywords

Thyroid Eye Disease, Eye Diseases, Graves Ophthalmopathy, Intervention/Treatment, VRDN-001 10 mg/kg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have completed at least 5 infusions and assessments required to determine proptosis responder status as measured by exophthalmometer 3 weeks post the fifth infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
  • Been a participant in either the VRDN-001-101 or VRDN-001-301 pivotal studies and found to be non-responder
  • Must agree to use highly effective contraception as specified in the protocol
  • Female Thyroid Eye Disease (TED) participants must have a negative urine pregnancy test

You CAN'T join if...

  • Must not have received prior treatment with another anti-IGF-1R monoclonal antibody or any other investigational agent for TED
  • Must not have used systemic corticosteroids 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 a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
  • Must not have received an investigational agent for any condition (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies) within 8 weeks prior to Day 1

Locations

  • Amy Patel Jain, MD Inc accepting new patients
    Newport Beach California 92660 United States
  • MACRO Trials, Inc. accepting new patients
    Los Angeles California 90048 United States
  • Cockerham Eye Consultants, PC accepting new patients
    San Diego California 92108 United States
  • Byers Eye Institute accepting new patients
    Palo Alto California 94303 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Viridian Therapeutics, Inc.
ID
NCT06179875
Phase
Phase 3 Thyroid Eye Disease Research Study
Study Type
Interventional
Participants
Expecting 143 study participants
Last Updated