A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)

  • STATUS
    Recruiting
  • End date
    Dec 20, 2023
  • participants needed
    76
  • sponsor
    Viridian Therapeutics, Inc.
Updated on 4 October 2022
Accepts healthy volunteers

Summary

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). This clinical trial will evaluate the safety, tolerability and pharmacokinetics (the concentration of drug in the blood over time) of VRDN-001 in healthy volunteers and in patients with TED. Study participants with TED will also be evaluated over time for changes in their signs and symptoms of TED compared to their baseline measurements.

Details
Condition Thyroid Eye Disease
Treatment Placebo, VRDN-001
Clinical Study IdentifierNCT05176639
SponsorViridian Therapeutics, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have moderate to severe active TED with documented evidence of ocular symptoms or
signs that began within 1 year prior to screening
Must have Clinical Activity Score (CAS) of ≥ 4 on the 7-item scale for the study (more
proptotic) eye
Must agree to use highly effective contraception as specified in the protocol
Female TED participants must have a negative serum pregnancy test

Exclusion Criteria

Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
Must not have used oral corticosteroids within 4 weeks prior to Day 1
Must not have received rituximab, tocilizumab or other immunosuppressive agents within
days prior to Day 1
Must not have evidence of optic nerve involvement within the previous 6 months
Must not have corneal decompensation in the study eye unresponsive to medical
management
Must not have had previous orbital irradiation or surgery for TED in the study eye
Must not have a history inflammatory bowel disease, or clinically significant ear
pathology or hearing impairment
Must not have received an investigational agent for any condition within 60 days
Female TED participants must not be pregnant or lactating
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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