An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED)
- Registration Number
- NCT06625411
- Lead Sponsor
- Viridian Therapeutics, Inc.
- Brief Summary
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED).
- Detailed Description
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with active TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/SC injections given every 4 weeks or every 8 weeks compared to placebo in participants with active TED.
Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 117
- Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
- Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
Key
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose
- Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose.
- Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
- Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
- Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
- 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 a history of inflammatory bowel disease
- Female TED participants who must not be pregnant or breastfeeding
NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VRDN-003 every 4 weeks VRDN-003 6 subcutaneous administrations of VRDN-003 VRDN-003 every 8 weeks VRDN-003 3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo VRDN-003 every 8 weeks Placebo 3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo Placebo every 4 weeks Placebo 6 subcutaneous administrations of placebo
- Primary Outcome Measures
Name Time Method Proptosis Responder Rate in the study eye At Week 24 Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]
- Secondary Outcome Measures
Name Time Method Change from baseline in proptosis in the study eye At Week 24 Change from baseline in proptosis in the study eye
Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0 At Week 24 Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0
Clinical Activity Responder Rate in the study eye At Week 24 Clinical Activity Responder Rate in the study eye (i.e., ≥ 2 points reduction in CAS from baseline in the study eye \[without a corresponding increase of ≥2 points in the fellow eye\])
Overall Responder Rate in the study eye At Week 24 Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]) AND ≥ 2 points reduction in CAS from baseline in the study eye \[without a corresponding increase of ≥2 points in the fellow eye\]
Change from baseline in Clinical Activity Score (CAS) in the study eye At Week 24 Change from baseline in Clinical Activity Score (CAS) in the study eye \[range, 0 to 7, with higher scores indicating greater level of inflammation\]
Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye At Week 24 Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye
Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0 At Week 24 Proportion of participants with a reduction in Diplopia Score to 0 from baseline (for participants with baseline Diplopia Score greater than 0)
Trial Locations
- Locations (31)
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
Alliance Research Institute - Canoga Park
🇺🇸Canoga Park, California, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Advancing Research International, LLC
🇺🇸Los Angeles, California, United States
Roski Eye Institute, Keck School of Medicine, USC
🇺🇸Los Angeles, California, United States
Alliance Research Institute - Lynwood
🇺🇸Lynwood, California, United States
A.P.J. Office
🇺🇸Newport Beach, California, United States
Byers Eye Institute at Stanford University
🇺🇸Palo Alto, California, United States
Pasadena Clinical Trials
🇺🇸Pasadena, California, United States
Senta Clinic
🇺🇸San Diego, California, United States
Ilumina Medical Research
🇺🇸Kissimmee, Florida, United States
Med-Care Research
🇺🇸Miami, Florida, United States
Hype Clinical Research LLC
🇺🇸Miami, Florida, United States
Anmed Health Services LLC
🇺🇸Miami, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Vision Medical Research
🇺🇸Orland Park, Illinois, United States
Opthalmic Consultants of Boston
🇺🇸East Weymouth, Massachusetts, United States
Fraser Eye Care Center
🇺🇸Fraser, Michigan, United States
Kahana Oculoplastic & Orbital Surgery
🇺🇸Livonia, Michigan, United States
University Health
🇺🇸Kansas City, Missouri, United States
S.L. Office
🇺🇸Las Vegas, Nevada, United States
Vector Clinical Trials
🇺🇸Sparks, Nevada, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Asheville Clinical Research
🇺🇸Asheville, North Carolina, United States
Baylor College of Medicine/Alkek Eye Center
🇺🇸Houston, Texas, United States
Gulf Coast Clinical Trials
🇺🇸Houston, Texas, United States
Neuro-Eye Clinical Trials
🇺🇸Houston, Texas, United States
University of Washington, Eye institute
🇺🇸Seattle, Washington, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States