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

Viridian Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Thyroid Eye Disease

Treatments: Drug: VRDN-003; Device: Autoinjector

Study type: Interventional

Funder types: Industry

Identifiers

NCT07155668

VRDN-003-304

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

VRDN-003 every 4 weeks using autoinjector

Experimental group

Description:

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

Treatment:

Device: Autoinjector

Drug: VRDN-003

VRDN-003 every 8 weeks using autoinjector

Experimental group

Description:

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

Treatment:

Device: Autoinjector

Drug: VRDN-003

VRDN-003 every 8 weeks using vial and syringe

Experimental group

Description:

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

Treatment:

Drug: VRDN-003