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)
- Conditions
- Thyroid Eye Disease
- Interventions
- Drug: Veligrotug (VRDN-001)Drug: Placebo
- Registration Number
- NCT06021054
- Lead Sponsor
- Viridian Therapeutics, Inc.
- Brief Summary
A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001 in participants with chronic thyroid eye disease (TED)
- Detailed 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 159
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Veligrotug (VRDN-001)10 mg/kg Veligrotug (VRDN-001) Drug: 5 IV Infusions of veligrotug (VRDN-001)10 mg/kg Placebo Drug Placebo Placebo Drug: 5 IV Infusions of placebo
- Primary Outcome Measures
Name Time Method Proptosis Responder Rate in the most proptotic eye Week 15 Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥2 mm from baseline \[without a corresponding increase of ≥2 mm in the other eye\])
- Secondary Outcome Measures
Name Time Method Change from baseline in proptosis in the most proptotic eye Week 15 Change from baseline in proptosis in the most proptotic eye
Clinical Activity Responder Rate in the most proptotic eye Week 15 Clinical Activity Responder Rate in the most proptotic eye (i.e., no worsening in CAS from baseline \[without a corresponding increase of ≥2 points in the other eye\])
Overall Responder Rate in the most proptotic eye Week 15 Overall Responder Rate (comprised of Proptosis Responder Rate and Clinical Activity Responder Rate) in the most proptotic 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)
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 greater than 0)
Trial Locations
- Locations (60)
Gazi University Medical Faculty Hospital
🇹🇷Ankara, Turkey
Akdeniz University Medical Faculty Hospital
🇹🇷Antalya, Turkey
Marmara University Faculty of Medicine
🇹🇷Istanbul, Turkey
Moorfield's Eye Hospital
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust - Western eye Hospital
🇬🇧London, United Kingdom
Guy's and St. Thomas NHS Trust
🇬🇧London, United Kingdom
USC Roski Eye Institute
🇺🇸Los Angeles, California, United States
Amy Patel Jain, MD
🇺🇸Newport Beach, California, United States
Stanford Byers Eye Institute
🇺🇸Palo Alto, California, United States
Cockerham Eye Consultants, PC
🇺🇸San Diego, California, United States
Bascom Palmer Eye Institute - Ophthalmology - Miami
🇺🇸Miami, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Family Eye Physicians, Ltd
🇺🇸Oak Lawn, Illinois, United States
Massachusetts Eye and Ear
🇺🇸Boston, Massachusetts, United States
Michigan State University, Department of Neurology
🇺🇸East Lansing, Michigan, United States
Washington University School of Medicine in St Louis - Ophthalmology
🇺🇸St. Louis, Missouri, United States
Steven Leibowitz, MD.
🇺🇸Las Vegas, Nevada, United States
Rutgers - New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine (BCM) - Ophthalmology
🇺🇸Houston, Texas, United States
Neuro Eye Clinical Trials
🇺🇸Houston, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
North Shore Private Hospital
🇦🇺Saint Leonards, New South Wales, Australia
CHU de Bordeaux - Hôpital Saint-André
🇫🇷Bordeaux, France
Centre Hospitalier Universitaire De Nantes - G. R. Laennec
🇫🇷Nantes, France
CH Nice
🇫🇷Nice, France
Charité - Universitätsmedizin Berlin KöR
🇩🇪Berlin, Germany
Universitätsklinikum Essen AöR
🇩🇪Essen, Germany
University Medical Center Freiburg
🇩🇪Freiburg, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Budapest Retina Intezet
🇭🇺Budapest, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika
🇭🇺Pécs, Hungary
Fondazione IRCCS Cà Granda
🇮🇹Milano, Italy
Auxologico San Luca
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Oculomedica Sp. z o.o.
🇵🇱Białystok, Poland
Optimum Profesorskie Centrum Okulistyki Sp. z o.o.
🇵🇱Gdansk, Poland
Centrum Medyczne Pulawska Sp. z o.o.
🇵🇱Piaseczno, Poland
Centrum Medyczne Piasta 47 sp. z o.o.
🇵🇱Wałbrzych, Poland
Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
🇪🇸Coruña, Spain
Hospital La Arruzafa
🇪🇸Córdoba, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Y Politécnico La Fe
🇪🇸Valence, Spain
Hospital Unviersitario Miguel Servet
🇪🇸Zaragoza, Spain
Hacettepe Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
Advancing Research International, LLC
🇺🇸Los Angeles, California, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Kahana Oculoplastic and Orbital Surgery
🇺🇸Livonia, Michigan, United States
The Center for Eye and Facial Plastic Surgery
🇺🇸Somerset, New Jersey, United States
Department of Ophthalmology, University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
CHU Angers
🇫🇷Angers, France
Ganglion Orvosi Kozpont
🇭🇺Pécs, Hungary
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Białystok, Poland
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, Spain
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