A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 Placebo VRDN-001 Placebo Participants with TED will be randomized to either veligrotug (VRDN-001) 10mg/kg or placebo.
- Primary Outcome Measures
Name Time Method Proptosis Responder Rate Week 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
Name Time Method Change from baseline in proptosis in the study eye Week 15 Change from baseline in proptosis in the study eye as measured by exophthalmometer
Proptosis Responder Rate in the most proptotic eye Week 15 Proptosis Responder Rate in the most proptotic eye as measured by MRI/CT
Change from baseline in proptosis in the most proptotic eye Week 15 Change from baseline in proptosis in the most proptotic eye as measured by MRI/CT
Change from baseline in CAS Week 15 Change from baseline in Clinical Activity Score (CAS) in the study eye
Overall Responder Rate Week 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 eye Week 15 Clinical Activity Responder Rate in the study eye
Diplopia Responder Rate Week 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 Rate Week 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 eye Week 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
Scroll for more (42 remaining)University of Colorado🇺🇸Aurora, Colorado, United States