An Open-label Study for Non-responders of VRDN-001-101 and VRDN-001-301 (OLE)
- Conditions
- Thyroid Eye Disease
- Interventions
- Drug: Intervention/Treatment
- Registration Number
- NCT06179875
- Lead Sponsor
- Viridian Therapeutics, Inc.
- Brief Summary
An open-label study for participants who received VRDN-001 or placebo and were non-responders at end of the treatment period assessment (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 143
-
Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity
-
Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
-
Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study
-
Not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason
-
Must agree to use highly effective contraception as specified in the protocol
⦁ Female TED participants must have a negative urine pregnancy test at screening
-
Be willing and able to comply with all the requirements of the protocol for the entire duration of the study
Key
Participants must not:
- Have received prior treatment with another anti-IGF-1R agent
- Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
- Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose
- Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit
- Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VRDN-001 10 mg/kg Intervention/Treatment 5 infusions of VRDN-001 10 mg/kg
- 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 \[without a corresponding increase of ≥ 2 mm in the other eye\]) at 3 weeks post the fifth IV infusion (i.e., Week 15)
- 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 at Week 15
Clinical Activity Responder Rate in the most proptotic eye Week 15 Clinical Activity Responder Rate in the most proptotic eye at Week 15
Overall Responder Rate in the most proptotic eye Week 15 Overall Responder Rate in the most proptotic eye at Week 15
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) at Week 15.
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) at Week 15
Trial Locations
- Locations (44)
Marmara University Faculty of Medicine
🇹🇷Istanbul, Turkey
Neuro-Eye Clinical Trials
🇺🇸Houston, Texas, United States
USC Eye Institute
🇺🇸Los Angeles, California, United States
Stanford Byers Eye Institute
🇺🇸Palo Alto, California, United States
University of Miami Miller School of Medicine, Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Ophthalmic Plastic, Reconstructive, Orbital and Cosmetic Surgery
🇺🇸Las Vegas, Nevada, United States
Hospital of the University of Pennsylvania Perleman Center
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Centre Hospitalier Universitaire de Montperllier Hopital Lapeyronie
🇫🇷Montpellier Cedex 5, Hérault, France
Centre Hospitalier Universitaire De Nantes G.R. Laenne
🇫🇷Saint-Herblain, Loire-Atlantique, France
CHU Angers
🇫🇷Angers Cedex, France
Universitatmedizin Gottingen
🇩🇪Göttingen, Niedersachsen, Germany
Charite - Universitatsmedizin Berlin KoR, Campus Virchow Klinikum, Klinik tor Augenheilkunde
🇩🇪Berlin, Germany
Universitatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Universitatsklinikum Essen AoR - Klinik fur Augenheilkunde
🇩🇪Essen, Germany
University Medical Center Freiburg
🇩🇪Freiburg, Germany
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
Centrum Medyczne Piasta
🇵🇱Walbrzych, Piasta, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Optimum Profesorskie Centrum Okulistyki
🇵🇱Gdansk, Poland
Centrum Medyczne Pulawska
🇵🇱Piaseczno, Poland
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hacettepe Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Gazi University Medical Faculty Hospital
🇹🇷Ankara, Turkey
Akdeniz University Medical Faculty Hospital
🇹🇷Antalya, Turkey
Norfolk and Norwich University ospital NHS Foundation Trust
🇬🇧Norwich, London, United Kingdom
University Hospital Bristol and Weston NHS Foundation Trust- Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
Imperial College Healthcare NHS Trust Western Eye Hospital
🇬🇧London, United Kingdom
Guy's and St. Thomas Trust
🇬🇧London, United Kingdom
Newcastle Eye Centre
🇬🇧Newcastle, United Kingdom
Advancing Research International, LLC
🇺🇸Newport Beach, California, United States
Cockerham Eye Consultants, PC
🇺🇸San Diego, California, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Vision Medical Research
🇺🇸Oak Lawn, Illinois, United States
Ophthalmic Consultants of Boston
🇺🇸East Weymouth, Massachusetts, United States
Kahana Oculoplastic & Orbital Surgery
🇺🇸Livonia, Michigan, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
The Center for Eye and Facial Plastic Surgery
🇺🇸Somerset, New Jersey, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Hospital Universitario Virgen de la Macarena
🇪🇸Sevilla, Spain
Hospital Arruzafa. Servicio de Oftalmologia
🇪🇸Córdoba, Spain
Hospital Universitario Miguel Servel
🇪🇸Zaragoza, Spain