Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Key Inclusion Criteria for Healthy Volunteers:
- Must be free of clinically significant disease or medical conditions as determined by
the Investigator
- Female volunteers must not be of child-bearing potential
Key Exclusion Criteria for Healthy Volunteers:
• Must not have a history of or any evidence of diabetes mellitus, recently diagnosed renal
impairment or inflammatory bowel disease, or clinically significant ear pathology or
hearing impairment
Key Inclusion Criteria for Participants with TED:
- 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
Key Exclusion Criteria for Participants with TED:
- 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
90 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
Accepts Healthy Volunteers
Call +1 (305) 4824309