An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED)
- Conditions
- Thyroid Eye Disease
- Interventions
- Drug: VRDN-003Drug: Placebo
- Registration Number
- NCT06625398
- 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 chronic 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 chronic TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as subcutaneous/SC injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic TED.
Participants who do not have a meaningful response at Week 24 may be eligible to receive additional subcutaneous injections of VRDN-003.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have received systemic corticosteroids for any condition, including TED, within 2 weeks prior to first dose.
- Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks 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 must not be pregnant or breastfeeding
NOTE: There are additional eligibility criteria for non-responders 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 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 VRDN-003 every 4 weeks VRDN-003 6 subcutaneous administrations of VRDN-003 Placebo every 4 weeks Placebo 6 subcutaneous administrations of placebo
- Primary Outcome Measures
Name Time Method Title: Proptosis Responder Rate in the study eye At Week 24 Description: 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
Clinical Activity Responder Rate in the study eye At Week 24 Description: Clinical Activity Responder Rate in the study eye (i.e., no worsening 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 no worsening in CAS from baseline in the study eye \[without a corresponding increase of ≥2 points in the fellow eye\]
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)
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 (17)
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Pasadena Clinical Trials
🇺🇸Pasadena, California, United States
Ilumina Medical Research
🇺🇸Kissimmee, Florida, United States
Anmed Health Services LLC
🇺🇸Miami, Florida, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Gulf Coast Clinical Trials
🇺🇸Houston, Texas, United States
Advancing Research International, LLC
🇺🇸Los Angeles, California, United States
A.P.J. Office
🇺🇸Newport Beach, California, United States
Senta Clinic
🇺🇸San Diego, California, 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
Neuro-Eye Clinical Trials
🇺🇸Houston, Texas, United States
Related News
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