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VRDN-003

Clinical trials are studying VRDN-003 in people with thyroid eye disease (TED). These studies look at safety, tolerability, and whether VRDN-003 improves signs and symptoms such as eye bulging and disease activity. The trials include people with TED of any duration, chronic TED, and active TED.

Table of Contents

Clinical trial overview

The available studies are testing VRDN-003 in people with thyroid eye disease (TED), a condition that affects the eyes.[1][2][3] All three trials are Phase 3 and have been authorised.[1][2][3]

These studies are looking mainly at safety, tolerability, and whether VRDN-003 improves signs and symptoms of TED.[1][2][3] Two of the studies compare VRDN-003 with placebo, which is a treatment with no active drug ingredients.[2][3]

The three Phase 3 studies

The first study, NCT06812325, is a safety and tolerability study in participants with TED of any duration.[1] It includes 322 participants and checks safety events through Week 24.[1]

The second study, 2024-514973-23-00, looks at efficacy, safety, and tolerability in people with chronic TED.[2] It includes 204 participants and measures the Overall Responder Rate at Week 24.[2]

The third study, 2024-514972-42-00, is for people with active TED.[3] It includes 142 participants and also measures the Overall Responder Rate at Week 24.[3]

In these studies, VRDN-003 is given as a series of subcutaneous injections, which means injections into the fat layer under the skin.[1][2][3] The studies test dosing every 4 weeks or every 8 weeks.[1][2][3]

Who the trials include

These trials are for people with thyroid eye disease.[1][2][3] One study includes people with TED of any duration, one focuses on chronic TED, and one focuses on active TED.[1][2][3]

This means the studies are looking at different stages of the same disease, so researchers can see how VRDN-003 performs in different patient groups.[1][2][3]

What the trials measure

The first study measures the rate of treatment-emergent adverse events, which are safety events that happen after treatment starts, through Week 24.[1]

The second and third studies measure the Overall Responder Rate at Week 24.[2][3] In the chronic TED study, an overall responder is someone with at least a 2 mm reduction in eye bulging and no worsening in CAS at Week 24 compared with before the first dose.[2] In the active TED study, an overall responder is someone with at least a 2 mm reduction in eye bulging and a CAS reduction of at least 2 points at Week 24 compared with before the first dose.[3]

These endpoints help researchers understand both effectiveness and safety in a clear way.[1][2][3]

Simple explanation of key terms

Safety means how often unwanted health problems happen during the study.[1]

Tolerability means how well people can take the treatment, or how acceptable it is to the body.[2][3]

Clinical Activity Score, or CAS, is a way to estimate disease severity and symptoms.[2][3]

Placebo means a treatment with no active drug ingredients, used for comparison.[2][3]

Week 24 is the point 24 weeks after treatment starts, when the main study results are checked.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT06812325 Phase 3 Thyroid eye disease Authorised 322
2024-514973-23-00 Phase 3 Chronic thyroid eye disease Authorised 204
2024-514972-42-00 Phase 3 Active thyroid eye disease Authorised 142

FAQ

  • What is being studied in the VRDN-003 trials? The trials are studying whether VRDN-003 is safe, tolerable, and effective in thyroid eye disease. Some studies compare VRDN-003 with placebo, which has no active drug ingredients.
  • Who can take part in these studies? The studies include participants with thyroid eye disease. The groups are people with TED of any duration, people with chronic TED, and people with active TED.
  • What phase are the VRDN-003 trials? All of the listed studies are Phase 3 trials. Phase 3 studies are larger trials that help show how well a treatment works and how safe it is.
  • What results are the trials measuring? The trials measure safety events and treatment response at Week 24. One main result is whether eye bulging improves by at least 2 mm, and some studies also look for no worsening or a reduction in Clinical Activity Score, or CAS.
  • How is VRDN-003 being given in these studies? VRDN-003 is being given as subcutaneous injections, which means injections into the fat layer under the skin. The studies test dosing every 4 weeks or every 8 weeks.

Ongoing Clinical Trials on VRDN-003

  • Study on the Effects of VRDN-003 for Patients with Active Thyroid Eye Disease

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary The Netherlands Poland Spain

  • Study on the Safety and Tolerability of VRDN-003 for Patients with Thyroid Eye Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Poland Spain

  • Study on the Effectiveness and Safety of VRDN-003 for Patients with Chronic Thyroid Eye Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary The Netherlands Poland Spain

Glossary

  • Thyroid eye disease (TED): A condition that affects the eyes and is being studied in all of these trials.
  • Active TED: TED that is currently active, meaning signs and symptoms are still changing or present.
  • Chronic TED: TED that has lasted for a longer time.
  • Phase 3: A later stage of clinical research that usually includes more participants and checks how well a treatment works and how safe it is.
  • Safety: How often unwanted health problems happen during the study.
  • Tolerability: How well people can take a treatment, or how acceptable it is to the body.
  • Placebo: A substance with no active drug ingredients, used for comparison in some trials.
  • Subcutaneous injection: An injection into the fat layer between the skin and muscle.
  • Eye bulging: When the eye sticks out more than normal, which can happen in TED.
  • Clinical Activity Score (CAS): A score used to estimate disease activity, symptoms, and severity.
  • Overall Responder Rate: The percentage of people who meet the study’s response rules, such as improved eye bulging and stable or improved disease activity.
  • Week 24: The point in the study 24 weeks after treatment starts, when main results are checked.

References

  1. https://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-vrdn-003-for-patients-with-thyroid-eye-disease/
  2. https://clinicaltrials.gov/study/2024-514973-23-00
  3. https://clinicaltrials.gov/study/2024-514972-42-00