A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants with Thyroid Eye Disease (TED)
- Conditions
- Thyroid Eye Disease
- Interventions
- Drug: VRDN-001 10 mg/kgDrug: VRDN-001 3 mg/kg
- Registration Number
- NCT06384547
- Lead Sponsor
- Viridian Therapeutics, Inc.
- Brief Summary
The investigational drug, 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 evaluate the safety and tolerability of VRDN-001 in patients with TED.
- Detailed Description
A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 231
- Have a clinical diagnosis of TED with or without proptosis and with any CAS (0 - 7) and in the opinion of the investigator may benefit from treatment
- Must agree to use highly effective contraception method as specified in the protocol
- Female TED participants must have a negative serum pregnancy test
- Not require immediate ophthalmological or orbital surgery in the study eye for any reason
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have used systemic corticosteroids, or selenium 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 received any other therapy for TED within 8 weeks prior to Day 1
- Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
- 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 decompression surgery involving excision of fat for TED in the study eye's orbit
- Must not have inflammatory bowel disease
- Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor.
- Must not have received an investigational agent for any condition within 8 weeks prior to Day 1
- Female TED participants must not be pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VRDN-001 10 mg/kg VRDN-001 10 mg/kg 5 infusions of VRDN-001 10 mg/kg 5 infusions of VRDN-001 3 mg/kg VRDN-001 3 mg/kg 5 infusions of VRDN-001 3 mg/kg
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Event (TEAE) incidence rate Week 15
- Secondary Outcome Measures
Name Time Method Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15 Week 15 Treatment Emergent Adverse Event (TEAE) incidence rate through Week 52 Week 52
Trial Locations
- Locations (49)
Advancing Research International, LLC
🇺🇸Las Vegas, Nevada, United States
Stanford Byers Eye Institute
🇺🇸Palo Alto, California, United States
Med-Care Research Inc.
🇺🇸Miami, Florida, United States
Cockerham Eye Consultants, PC
🇺🇸San Diego, California, United States
FOMAT Medical Research
🇺🇸Santa Maria, California, United States
Edward Jenner Research Group Center LLC
🇺🇸Plantation, Florida, United States
University of Colorado - Dept of Ophthalmology
🇺🇸Aurora, Colorado, United States
Sina Medical Center LLC
🇺🇸Homestead, Florida, United States
Sarasota Retina Institute
🇺🇸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
Massachusetts Eye and Ear
🇺🇸Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
🇺🇸Weymouth, Massachusetts, United States
Fraser Eye Care Center
🇺🇸Fraser, Michigan, United States
Kahana Oculoplastic & Orbital Surgery
🇺🇸Livonia, Michigan, United States
University of Minnesota, Department of Ophthalmology and Visual Neurosciences
🇺🇸Minneapolis, Minnesota, United States
Rutgers- New Jersey Medical School- Newark
🇺🇸Newark, New Jersey, United States
New York Eye Ear Infirmary of Mount Sinai
🇺🇸New York, New York, United States
Baylor College of Medicine (BCM) - Ophthalmology
🇺🇸Houston, Texas, United States
Neuro-Eye Clinical Trials
🇺🇸Houston, Texas, United States
Neuro-Ophthalmology of Texas, PLLC
🇺🇸Houston, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States
Sydney Eye Hospital
🇦🇺Sydney, Australia
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
North Shore Eye Surgery
🇦🇺Sydney, Australia
CHU d'Angers
🇫🇷Angers, France
Centre Hospitalier National D'ophtalmologie
🇫🇷Des Quinze Vingts Paris, France
CH Nice
🇫🇷Nice, France
AP-HP - Hôpital de la Pitié Salpétrière
🇫🇷Paris, France
Johannes Gutenberg-University Medical Center
🇩🇪Mainz, Germany
NZOZ E-Vita
🇵🇱Bialystok, Poland
Specjalistyczny Osrodek Okulistyczny Oculomedica
🇵🇱Bydgoszcz, Poland
Santa Familia PTG Lodz
🇵🇱Lódz, Poland
Panstwowy Instytut Medyczny MSWiA
🇵🇱Warszawa, Poland
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
🇵🇱Wroclaw, Poland
Clinica Bonanova de Cirugia Ocular
🇪🇸Barcelona, Spain
Hospital Arruzafa
🇪🇸Córdoba, Spain
ClÃnica Universidad de Navarra
🇪🇸Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Universitario Virgen De La Macarena, Servicio de OftalmologÃa
🇪🇸Sevilla, Spain
Western Eye Hospital, Imperial College NHS Trust
🇬🇧London, United Kingdom
Miguel Servet University Hospital, Clinical Trials Unit
🇪🇸Zaragoza, Spain
Northwick Park Hospital
🇬🇧London, United Kingdom
Guy's and St. Thomas NHS Trust
🇬🇧London, United Kingdom
United Medical Research Institute
🇺🇸Inglewood, California, United States