A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)
Thyroid Eye Disease
About this trial
This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Graves Ophthalmopathy, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy
Eligibility Criteria
Key Inclusion Criteria for Healthy Volunteers:
- Must be free of clinically significant disease or medical conditions as determined by the Investigator
- Female volunteers must not be of child-bearing potential
Key Exclusion Criteria for Healthy Volunteers:
• Must not have a history of or any evidence of diabetes mellitus, recently diagnosed renal impairment or inflammatory bowel disease, or clinically significant ear pathology or hearing impairment
Key Inclusion Criteria for Participants with TED:
- Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 1 year prior to screening
- Must have Clinical Activity Score (CAS) of ≥ 4 on the 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 for Participants with TED:
- Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
- Must not have used oral corticosteroids within 4 weeks prior to Day 1
- Must not have received rituximab, tocilizumab or other immunosuppressive agents within 90 days prior to Day 1
- Must not have evidence of optic nerve involvement within the previous 6 months
- Must not have corneal decompensation in the study eye unresponsive to medical management
- Must not have had previous orbital irradiation or surgery for TED in the study eye
- Must not have a history inflammatory bowel disease, or clinically significant ear pathology or hearing impairment
- Must not have received an investigational agent for any condition within 60 days
- Female TED participants must not be pregnant or lactating
Sites / Locations
- The Private Office of Raymond Douglas, MD, PhDRecruiting
- USC Roski Eye InstituteRecruiting
- Byers Eye Institute/Stanford UniversityRecruiting
- Senta ClinicRecruiting
- University of California, San Francisco
- University of California, San FranciscoRecruiting
- University of Colorado - Department of OphthalmologyRecruiting
- University of Florida Bascom Palmer Eye CenterRecruiting
- Sarasota Retina InstituteRecruiting
- Emory University Eye CenterRecruiting
- Massachusetts Eye and EarRecruiting
- Michigan State University - Department of Neurology and OphthalmologyRecruiting
- University of Minnesota Eye ClinicRecruiting
- Washington University St. LouisRecruiting
- TKL Research, Inc.Recruiting
- Rutgers New Jersey Medical School - Department of Ophthalmology & Visual ScienceRecruiting
- Duke Eye CenterRecruiting
- Scheie Eye Institute Dept of OPH University of PennsylvaniaRecruiting
- Department of Neuro-Ophthalmology Wills Eye HospitalRecruiting
- UPMC Eye CenterRecruiting
- Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.Recruiting
- Baylor College of Medicine - Alkek Eye CenterRecruiting
- Moran Eye CenterRecruiting
- University of Washington - Department of OphthalmologyRecruiting
- Marshall Health Dept of Clinical & Translational Sciences
- Oshawa ClinicRecruiting
- University of Ottawa Eye Institute - The Ottawa Hospital Research InstituteRecruiting
- Ottawa Hospital Research Institute (OHRI)
- Charité Universitaetsmedizin BerlinRecruiting
- Klinik und Poliklinik für AugenheilkundeRecruiting
- Istituto Auxologico ItalianoRecruiting
- Istituto Auxologico Italiano
- Amsterdam University Medical CenterRecruiting
- Erasmus MCRecruiting
- Eye Research Department South Wing St Thomas' HospitalRecruiting
- Eye Research Department South Wing St Thomas' Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1/2 MAD (HV and TED)
Phase 3 Cohort (THRIVE)
Healthy participants and participants with TED will be randomized to receive two intravenous infusions of VRDN-001 or placebo with an interval of 3 weeks.
Participants with TED will be randomized to either VRDN-001 10mg/kg or placebo.