A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Purpose

This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)

Condition

  • Thyroid Eye Disease

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003 - Not require immediate ophthalmological or orbital surgery in the study eye for any reason - Must agree to use highly effective contraception as specified in the protocol - Female TED participants must have a negative serum pregnancy test at screening

Exclusion Criteria

  • Must not have received prior treatment with another anti-IGF-1R therapy - Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose. - Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose - Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose - Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose - Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit - Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results - Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor - Must not have a history of inflammatory bowel disease - Female TED participants must not be pregnant or breastfeeding

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized to one of the three study arms.
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
This is an open label study with no masking

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VRDN-003 every 4 weeks using autoinjector 		6 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 5 doses of 300mg]
  • Drug: VRDN-003
    VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
  • Device: Autoinjector
    The autoinjector is a single-dose, disposable, ready-to-use delivery device
Experimental
VRDN-003 every 8 weeks using autoinjector 		3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg]
  • Drug: VRDN-003
    VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
  • Device: Autoinjector
    The autoinjector is a single-dose, disposable, ready-to-use delivery device
Experimental
VRDN-003 every 8 weeks using vial and syringe 		3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg]
  • Drug: VRDN-003
    VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

More Details

Status
Active, not recruiting
Sponsor
Viridian Therapeutics, Inc.

Study Contact

Detailed Description

This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.