A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2)

Viridian Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Thyroid Eye Disease

Treatments: Drug: VRDN-001 10 mg/kg Drug:

Study type: Interventional

Funder types: Industry

Identifiers

NCT06021054

VRDN-001-301

Details and patient eligibility

About

A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001 in participants with chronic thyroid eye disease (TED)

Full description

A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with chronic thyroid eye disease (TED)

Enrollment: 159 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began > 15 months prior to screening
• Must have Clinical Activity Score (CAS) of (0-7) item scale for the study (more proptotic) eye
• Must agree to use highly effective contraception as specified in the protocol
• Female TED participants must have a negative serum pregnancy test

Key Exclusion Criteria:

• Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
• Must not have used systemic corticosteroids within 2 weeks prior to Day 1
• Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
• Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
• Must not have had previous orbital irradiation or surgery for TED in the study eye
• Must not have a history inflammatory bowel disease
• Must not have a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss
• Must not have received an investigational agent for any condition
• Female TED participants must not be pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 2 patient groups

VRDN-001 10 mg/kg

Experimental group

Description:

Drug: 5 Infusions of VRDN-001 10 mg/kg

Treatment:

Drug: VRDN-001 10 mg/kg Drug:

Placebo Drug

Experimental group

Description:

Placebo Drug: 5 Infusions of placebo

Treatment:

Drug: VRDN-001 10 mg/kg Drug: