A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-11-30

Brief Summary

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This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)

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Detailed Description

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This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.

Conditions

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Thyroid Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to one of the three study arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open label study with no masking

Study Groups

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VRDN-003 every 4 weeks using autoinjector

6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\]

Group Type EXPERIMENTAL

VRDN-003

Intervention Type DRUG

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

Autoinjector

Intervention Type DEVICE

The autoinjector is a single-dose, disposable, ready-to-use delivery device

VRDN-003 every 8 weeks using autoinjector

3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]

Group Type EXPERIMENTAL

VRDN-003

Intervention Type DRUG

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

Autoinjector

Intervention Type DEVICE

The autoinjector is a single-dose, disposable, ready-to-use delivery device

VRDN-003 every 8 weeks using vial and syringe

3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]

Group Type EXPERIMENTAL

VRDN-003

Intervention Type DRUG

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

Interventions

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VRDN-003

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

Intervention Type DRUG

Autoinjector

The autoinjector is a single-dose, disposable, ready-to-use delivery device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
* Not require immediate ophthalmological or orbital surgery in the study eye for any reason
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening

Exclusion Criteria

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids 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/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 or 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No