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An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED)
EU CTIS ID: 2024-514972-42-00
What this study is testing
To determine if VRDN-003 is efficacious (meaning if VRDN-003 affects the signs and symptoms of TED), safe and tolerable (meaning if the body reacts acceptably to VRDN-003) when administered as a series of subcutaneous/SC (injection into layer of fat between skin and muscle) injections given every 4 weeks or every 8 weeks compared to placebo (a substance with no active drug ingredients) in participants with active TED
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult males or females, ≥18 to ≤75 years of age who have a clinical diagnosis of TED with a value ≥ 3 on the CAS scale
- Must have moderate to severe active TED with eye bulging value in the study eye before the first dose as defined in the protocol and at least one additional sign/symptom as described in the protocol
- Have experienced eye-related signs or symptoms that began within 15 months before the first study visit
- Must agree to use highly effective contraception as specified in the protocol
- Female participants must have a negative pregnancy test at first study visit
You likely can't join if
- Received prior treatment with another anti-IGF-1R therapy
- Received corticosteroids (drugs that reduce inflammation in the body) for any condition, including TED, within 2 weeks prior to first dose
- Received other immunosuppressive drugs (drugs that dampen the body’s immune response) or any other therapy for TED within 12 weeks prior to first dose or another investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
- Have had previous orbital irradiation or decompression surgery for TED or a pre-existing eye condition which in the study doctor’s opinion, would interfere with interpretation of study results
- Have abnormal hearing test before first dose. History of ear conditions considered significant by study doctor
- Have inflammatory bowel disease (conditions that involve inflammation of the gastrointestinal [GI] tract)
See the full eligibility criteria
- Adult males or females, ≥18 to ≤75 years of age who have a clinical diagnosis of TED with a value ≥ 3 on the CAS scale
- Must have moderate to severe active TED with eye bulging value in the study eye before the first dose as defined in the protocol and at least one additional sign/symptom as described in the protocol
- Have experienced eye-related signs or symptoms that began within 15 months before the first study visit
- Must agree to use highly effective contraception as specified in the protocol
- Female participants must have a negative pregnancy test at first study visit
- Received prior treatment with another anti-IGF-1R therapy
- Received corticosteroids (drugs that reduce inflammation in the body) for any condition, including TED, within 2 weeks prior to first dose
- Received other immunosuppressive drugs (drugs that dampen the body’s immune response) or any other therapy for TED within 12 weeks prior to first dose or another investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
- Have had previous orbital irradiation or decompression surgery for TED or a pre-existing eye condition which in the study doctor’s opinion, would interfere with interpretation of study results
- Have abnormal hearing test before first dose. History of ear conditions considered significant by study doctor
- Have inflammatory bowel disease (conditions that involve inflammation of the gastrointestinal [GI] tract)
- Female participants who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.