An Open-label Study for Non-responders of VRDN-001-101 and VRDN-001-301 (OLE)

Purpose

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

Condition

  • Thyroid Eye Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity 2. Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies 3. Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study 4. Not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason 5. Must agree to use highly effective contraception as specified in the protocol ⦁ Female TED participants must have a negative urine pregnancy test at screening 6. Be willing and able to comply with all the requirements of the protocol for the entire duration of the study

Exclusion Criteria

Participants must not: 1. Have received prior treatment with another anti-IGF-1R agent 2. Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose 3. Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose 4. Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose 5. Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit 6. Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single treatment assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VRDN-001 10 mg/kg
5 infusions of VRDN-001 10 mg/kg
  • Drug: Intervention/Treatment
    VRDN-001 10 mg/kg (5 infusions of VRDN-001 10 mg/kg)

Recruiting Locations

More Details

NCT ID
NCT06179875
Status
Active, not recruiting
Sponsor
Viridian Therapeutics, Inc.