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Vrdn-001

Clinical trials are studying Vrdn-001 in people with thyroid eye disease, also called TED. These studies look at safety, tolerability, and how well the treatment works, including in chronic TED and in people who did not respond in earlier trials. The trials include both patients with TED and some healthy volunteers.

Table of contents

Trial overview

The available studies of Vrdn-001 are all about thyroid eye disease (TED), a condition that affects the eyes and can cause bulging and inflammation.[1] The trial data show that researchers studied Vrdn-001 in people with TED of any duration, people with chronic TED, and in one study, normal healthy volunteers as well as TED patients.[1][2]

All four trials in the source data were interventional studies, which means the researchers gave a treatment and then compared outcomes.[1][2][3][4] The studies were completed, and they focused on safety, tolerability, and how well Vrdn-001 worked for TED.[1][3][4]

Who participated

Most participants were people with TED, including those with chronic thyroid eye disease and those with TED of any duration.[1][3] One study also included normal healthy volunteers, meaning people without the disease who took part to help researchers learn more about the treatment in a controlled way.[2]

One open-label study was designed for people who were non-responders in earlier pivotal studies, meaning they did not meet the study response goal after the earlier treatment period.[4] That study gave these participants another chance to receive Vrdn-001 and let researchers assess safety and efficacy again.[4]

Trial phases and study design

The source data include Phase 3 and Phase 4 trials.[1][2][3][4] Phase 3 studies are usually larger studies that help confirm whether a treatment works and is safe enough for wider use.[1][3][4] Phase 4 studies are done later and can add more information about real-world use and safety.[2]

Several studies compared Vrdn-001 with placebo, which is a treatment without the active study drug.[2][3] The open-label study was different because participants knew they were receiving the study treatment, which is what open-label means.[4]

The trial schedules in the data often used five intravenous infusions, meaning the treatment was given through a vein several times over the study period.[1][3][4] One study also described a dose range of 3.0 to 20.0 mg/kg, while other studies used 10 mg/kg.[2][1][3][4]

What the trials measured

The main safety measures were adverse events (AEs) and serious adverse events (SAEs), which are unwanted medical problems that happen during a study.[1][2][3][4] The studies also tracked any clinically important changes in other safety checks.[2][3][4]

Several efficacy outcomes focused on proptosis, which means eye bulging.[2][3][4] A common response goal was a reduction of at least 2 mm in the study eye without a similar worsening in the other eye, measured with an exophthalmometer, a tool used to measure how far the eye sticks out.[2][3][4]

Some studies also measured Clinical Activity Score (CAS), which shows how active the disease is by looking at signs of inflammation.[2][3][4] In the source data, response was often checked 3 weeks after the fifth infusion, which was Week 15.[1][2][3][4]

Key studies in the data

NCT06384547 was a Phase 3 study in 297 people with TED of any duration.[1] It was designed to confirm the safety and tolerability of Vrdn-001 given as five IV infusions of 10 mg/kg every three weeks, and its main outcome was the rate of treatment-emergent adverse events through Week 15.[1]

NCT06021054 was a Phase 3 study in 290 people with chronic TED.[3] It compared Vrdn-001 with placebo and measured an overall response rate based on both proptosis response and clinical activity response at 3 weeks after the fifth infusion, while also tracking safety events.[3]

NCT05176639 was a Phase 4 study in 157 participants, including normal healthy volunteers and people with TED.[2] This study looked at safety, tolerability, efficacy, and also pharmacokinetic and pharmacodynamic profiles, which describe how the body handles the treatment and how the treatment affects the body.[2]

2023-507350-33-00 was an open-label Phase 3 study in 147 people who had not responded in earlier pivotal studies.[4] It provided access to Vrdn-001 again and measured overall response rate and safety outcomes at Week 15.[4]

What these results may mean for patients

These studies show that Vrdn-001 was tested in several groups of people with TED, including those with long-lasting disease and those who had not improved in earlier trials.[1][3][4] The research focused not only on whether the treatment could help eye bulging and disease activity, but also on whether it could be given safely.[1][2][3][4]

Because the trials used clear response measures, such as changes in proptosis and CAS, they were designed to show whether Vrdn-001 made a meaningful difference for people with TED.[2][3][4] The completed studies give a structured picture of how the treatment was tested in later-stage clinical research.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
NCT06384547 Phase 3 Thyroid eye disease Completed 297
NCT06021054 Phase 3 Chronic thyroid eye disease Completed 290
NCT05176639 Phase 4 Thyroid eye disease Completed 157
2023-507350-33-00 Phase 3 Thyroid eye disease Completed 147

FAQ

  • What is being studied in Vrdn-001 trials? The trials are studying whether Vrdn-001 is safe, tolerable, and effective in thyroid eye disease. Some studies also measure how the treatment affects eye bulging and disease activity.
  • Who can take part in these studies? Most participants are people with thyroid eye disease, including those with chronic TED or TED of any duration. One study also included normal healthy volunteers.
  • What trial phases are listed for Vrdn-001? The data include Phase 3 and Phase 4 studies. These later-phase trials usually focus on confirming safety and checking how well the treatment works in larger groups.
  • What outcomes do the trials measure? The trials measure safety events, such as adverse events and serious adverse events. They also measure response rates, including reduction in proptosis, which means less eye bulging, and changes in clinical activity score.
  • Are any studies for people who did not respond before? Yes. One open-label study was designed for participants who were non-responders in earlier pivotal studies. Open-label means everyone knew they were receiving the study treatment.

Ongoing Clinical Trials on Vrdn-001

  • Study of VRDN-001 compared to placebo to evaluate safety and effectiveness in adults with chronic thyroid eye disease

    Not recruiting

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

  • Study on the Safety and Effectiveness of VRDN-001 for Patients with Thyroid Eye Disease

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany The Netherlands Spain

  • Study of VRDN-001 for Patients with Thyroid Eye Disease Who Did Not Respond to Previous Treatment

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Hungary Italy The Netherlands +2

  • Study on the Safety and Tolerability of VRDN-001 for Patients with Thyroid Eye Disease

    Not recruiting

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

Glossary

  • Thyroid eye disease (TED): A condition that affects the eyes and can cause bulging, irritation, and inflammation. The trials in this data study Vrdn-001 in people with TED.
  • Chronic TED: Long-lasting thyroid eye disease. One Vrdn-001 trial focused on people with chronic TED.
  • Phase 3: A later stage of clinical research that often studies a treatment in a larger group to confirm safety and effectiveness.
  • Phase 4: A study phase done after earlier testing, often to learn more about safety and how well a treatment works in broader groups.
  • Interventional study: A study where researchers give a treatment or placebo and then compare outcomes.
  • Placebo: A comparison treatment that does not contain the active study drug. It helps researchers see whether the study treatment works better than no active treatment.
  • Safety and tolerability: Safety means how often unwanted medical problems happen. Tolerability means how well people can handle the treatment.
  • Efficacy: How well a treatment works for the condition being studied.
  • Adverse event (AE): Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Serious adverse event (SAE): A more serious unwanted medical problem, such as one that is life-threatening or needs hospital care.
  • Proptosis: Bulging of the eye. Some Vrdn-001 trials measured whether proptosis improved.
  • Clinical Activity Score (CAS): A score that shows how active or inflamed the eye disease is. Lower scores can mean less disease activity.

References