An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
REVEAL-1
REVEAL-1 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
1 other identifier
interventional
132
1 country
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2024
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2024
CompletedFirst Submitted
Initial submission to the registry
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2026
ExpectedApril 14, 2026
April 1, 2026
1.5 years
October 1, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proptosis Responder Rate in the most proptotic eye as measured by exophtalmometer
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophtalmometer \[without a corresponding increase of ≥2 mm in the other eye\]
At Week 24
Secondary Outcomes (9)
Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer
At Week 24
Proptosis Responder Rate in the most proptotic eye as measured by MRI
At Week 24
Change from baseline in proptosis in the most proptotic eye as measured by MRI
At Week 24
Overall Responder Rate in the most proptotic eye as measured by exophthalmometer
At Week 24
Change from baseline in Clinical Activity Score (CAS) in the most proptotic eye (as measured by exophthalmometer)
At Week 24
- +4 more secondary outcomes
Study Arms (3)
VRDN-003 every 4 weeks
EXPERIMENTAL6 subcutaneous administrations of VRDN-003
VRDN-003 every 8 weeks
EXPERIMENTAL3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Placebo every 4 weeks
PLACEBO COMPARATOR6 subcutaneous administrations of placebo
Interventions
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
All participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Alliance Research Institute - Canoga Park
Canoga Park, California, 91304, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
United Medical Research Institute
Inglewood, California, 90301, United States
Advancing Research International, LLC
Los Angeles, California, 90023, United States
Roski Eye Institute, Keck School of Medicine, USC
Los Angeles, California, 90033, United States
Alliance Research Institute - Lynwood
Lynwood, California, 90262, United States
A.P.J. Office
Newport Beach, California, 92660, United States
Byers Eye Institute at Stanford University
Palo Alto, California, 94303, United States
Pasadena Clinical Trials
Pasadena, California, 91101, United States
Senta Clinic
San Diego, California, 92108, United States
C&A Clinical Trials Corp
Cape Coral, Florida, 33990, United States
Ilumina Medical Research
Kissimmee, Florida, 34744, United States
Med-Care Research
Miami, Florida, 33125, United States
Continental Clinical Research
Miami, Florida, 33144, United States
Hype Clinical Research LLC
Miami, Florida, 33145, United States
Anmed Health Services LLC
Miami, Florida, 33193, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328, United States
Vision Medical Research
Orland Park, Illinois, 60462, United States
Opthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189, United States
Fraser Eye Care Center
Fraser, Michigan, 48026, United States
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152, United States
University Health
Kansas City, Missouri, 64108, United States
S.L. Office
Las Vegas, Nevada, 89144, United States
Vector Clinical Trials
Sparks, Nevada, 89436, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
Asheville Clinical Research
Asheville, North Carolina, 28803, United States
Duke Eye Center
Durham, North Carolina, 27705, United States
Baylor College of Medicine/Alkek Eye Center
Houston, Texas, 77030, United States
Gulf Coast Clinical Trials
Houston, Texas, 77070, United States
Neuro-Eye Clinical Trials
Houston, Texas, 77074, United States
University of Washington, Eye institute
Seattle, Washington, 98104, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, Investigator, Outcomes Assessor and Sponsor will be masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2024
First Posted
October 3, 2024
Study Start
August 27, 2024
Primary Completion
February 12, 2026
Study Completion (Estimated)
November 15, 2026
Last Updated
April 14, 2026
Record last verified: 2026-04