Efficacy and safety of VRDN-003 for chronic Thyroid Eye Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of an investigational drug called VRDN-003 in individuals with chronic Thyroid Eye Disease (TED). It is a randomized, double-masked, placebo-controlled study where participants will receive subcutaneous injections of VRDN-003 every 4 or 8 weeks. The study aims to determine if the treatment is effective compared to a placebo in alleviating symptoms of TED. Participants who do not show a meaningful response at Week 24 may be eligible for additional doses of the drug.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria:

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids or steroid eye drops 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 for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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. Must also not have a 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

NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.

Where it's running

• Scottsdale Clinical Trials
  Scottsdale, Arizona, United States Recruiting
• Alliance Research Institute - Canoga Park
  Canoga Park, California, United States Recruiting
• Marvel Clinical Research
  Huntington Beach, California, United States Recruiting
• United Medical Research Institute
  Inglewood, California, United States Recruiting
• Advancing Research International, LLC
  Los Angeles, California, United States Recruiting
• Roski Eye Institute, Keck School of Medicine, USC
  Los Angeles, California, United States Recruiting

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.