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A Safety, Tolerability and Efficacy Study of VRDN-001 in Persons with Chronic Thyroid Eye Disease (TED)
EU CTIS ID: 2023-507217-10-00
What this study is testing
To determine the safety, tolerability, and efficacy of VRDN- 001 when given as 5 infusions of 10 mg/kg compared to placebo in participants with chronic 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
- 1. Males and/or females of age ≥18 to ≤75 years of age and older who have a clinical diagnosis of TED with any degree of disease severity and symptoms as measured by the CAS scale (0-7).
- 2. Participants must have moderate to severe chronic TED with proptosis (eye bulging) of at least 3 mm and >17 mm measurement at pre-dose baseline (Day -1 or Day 1) in the study eye.
- 3. Have experienced eye-related symptoms or signs that began more than 15 months before study screening.
- 4. Must agree to use highly effective contraception as specified in the protocol.
- 5. Female TED participants must have a negative serum pregnancy test at Screening.
You likely can't join if
- 1. Participants who have previously received treatment with other anti-IGF-1R therapy
- 2. Participants who have taken corticosteroids (except topically) or selenium (except multivitamins) for any condition, including TED, within 2 weeks before starting study medication. Also exclusionary are injections of corticosteroids into the eye within 3 months prior to the first dose of study medication or having received greater than 3 injections of corticosteroids into the eye at any time.
- 3. Participants who have received immunosuppressive agents, radioactive iodine, any other therapy for TED, or an investigational agent for any condition within 8 weeks prior to the first dose of study medication.
- 4. Participants who have a decrease in disease severity and symptoms as measured by CAS scale of at least 2 points in the study eye between screening and one day before treatment, for participants who had a CAS greater than 2 at screening.
- 5. Participants who have a decrease of at least 2 mm in proptosis (eye bulging) in the study eye from screening to one day before treatment.
- 6. Participants who require immediate surgical intervention and/or have other eye conditions as evaluated by the study doctor that are not responding to treatment.
See the full eligibility criteria
- 1. Males and/or females of age ≥18 to ≤75 years of age and older who have a clinical diagnosis of TED with any degree of disease severity and symptoms as measured by the CAS scale (0-7).
- 2. Participants must have moderate to severe chronic TED with proptosis (eye bulging) of at least 3 mm and >17 mm measurement at pre-dose baseline (Day -1 or Day 1) in the study eye.
- 3. Have experienced eye-related symptoms or signs that began more than 15 months before study screening.
- 4. Must agree to use highly effective contraception as specified in the protocol.
- 5. Female TED participants must have a negative serum pregnancy test at Screening.
- 1. Participants who have previously received treatment with other anti-IGF-1R therapy
- 2. Participants who have taken corticosteroids (except topically) or selenium (except multivitamins) for any condition, including TED, within 2 weeks before starting study medication. Also exclusionary are injections of corticosteroids into the eye within 3 months prior to the first dose of study medication or having received greater than 3 injections of corticosteroids into the eye at any time.
- 3. Participants who have received immunosuppressive agents, radioactive iodine, any other therapy for TED, or an investigational agent for any condition within 8 weeks prior to the first dose of study medication.
- 4. Participants who have a decrease in disease severity and symptoms as measured by CAS scale of at least 2 points in the study eye between screening and one day before treatment, for participants who had a CAS greater than 2 at screening.
- 5. Participants who have a decrease of at least 2 mm in proptosis (eye bulging) in the study eye from screening to one day before treatment.
- 6. Participants who require immediate surgical intervention and/or have other eye conditions as evaluated by the study doctor that are not responding to treatment.
- 7. Female participants who are pregnant or breastfeeding.
- 8. Have abnormal baseline hearing assessment
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Israel
- Australia
- Turkey
- United States
- United Kingdom
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 Canada; Israel; Australia; Turkey; United States; United Kingdom. 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.