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A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )

Phase 3
Completed
Conditions
Thyroid Eye Disease
Interventions
Drug: VRDN-001 Phase 3 Cohort (THRIVE)
Drug: VRDN-001 Placebo
Registration Number
NCT05176639
Lead Sponsor
Viridian Therapeutics, Inc.
Brief Summary

The investigational drug, veligrotug (VRDN-001), is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to establish the safety, tolerability, and efficacy of veligrotug, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of veligrotug in active TED patients who received 10 mg/kg.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
113
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Phase 3 Cohort (THRIVE) veligrotug (VRDN-001)VRDN-001 Phase 3 Cohort (THRIVE)Participants with TED will be randomized to either veligrotug (VRDN-001) 10mg/kg or placebo.
Phase 3 Cohort (THRIVE) VRDN-001 PlaceboVRDN-001 PlaceboParticipants with TED will be randomized to either veligrotug (VRDN-001) 10mg/kg or placebo.
Primary Outcome Measures
NameTimeMethod
Proptosis Responder RateWeek 15

Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline \[without a corresponding increase of ≥ 2 mm in the fellow eye\] as measured by exophthalmometer)

Secondary Outcome Measures
NameTimeMethod
Change from baseline in proptosis in the study eyeWeek 15

Change from baseline in proptosis in the study eye as measured by exophthalmometer

Proptosis Responder Rate in the most proptotic eyeWeek 15

Proptosis Responder Rate in the most proptotic eye as measured by MRI/CT

Change from baseline in proptosis in the most proptotic eyeWeek 15

Change from baseline in proptosis in the most proptotic eye as measured by MRI/CT

Change from baseline in CASWeek 15

Change from baseline in Clinical Activity Score (CAS) in the study eye

Overall Responder RateWeek 15

Overall Responder Rate comprising Proptosis Responder Rate as measured by exophthalmometer and Clinical Activity Responder Rate in the study eye

Clinical Activity Responder Rate in the study eyeWeek 15

Clinical Activity Responder Rate in the study eye

Diplopia Responder RateWeek 15

Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0)

Diplopia Resolution RateWeek 15

Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0)

Proportion of participants with a CAS score of zero or one in the study eyeWeek 15

Proportion of participants with a CAS of zero or one in the study eye

Trial Locations

Locations (52)

University of Colorado

🇺🇸

Aurora, Colorado, United States

Sina Medical Center

🇺🇸

Homestead, Florida, United States

Med-Care Research Inc.

🇺🇸

Miami, Florida, United States

Edward Jenner Research Group Center LLC

🇺🇸

Plantation, Florida, United States

Sarasota Retina Institue

🇺🇸

Sarasota, Florida, United States

Vision Medical Research Inc.

🇺🇸

Orland Park, Illinois, United States

University Health Diabetes, Endocrinology & Nephrology Center

🇺🇸

Kansas City, Kansas, United States

KU Medical Center, University of Kansas

🇺🇸

Kansas City, Kansas, United States

Fraser Eye Care Center

🇺🇸

Fraser, Michigan, United States

Kahana Oculoplastic & Orbital Surgery

🇺🇸

Livonia, Michigan, United States

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University of Colorado
🇺🇸Aurora, Colorado, United States

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