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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized to one of the three study arms.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Participants, Investigator, Outcomes Assessor and Sponsor will be masked.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VRDN-003 every 4 weeks 		6 subcutaneous administrations of VRDN-003
  • Drug: VRDN-003
    VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Experimental
VRDN-003 every 8 weeks 		3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
  • Drug: VRDN-003
    VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
  • Drug: Placebo
    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.
Placebo Comparator
Placebo every 4 weeks 		6 subcutaneous administrations of placebo
  • Drug: Placebo
    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.

Recruiting Locations

Scottsdale Clinical Trials
Scottsdale, Arizona 85260
Contact:
Coordinator
480-382-7909

Alliance Research Institute - Canoga Park
Canoga Park, California 91304
Contact:
Coordinator
951-283-3402

Marvel Clinical Research
Huntington Beach, California 92647
Contact:
Coordinator
714-375-5970

United Medical Research Institute
Inglewood, California 90301
Contact:
Coordinator
310-645-4673

Advancing Research International, LLC
Los Angeles, California 90023
Contact:
Coordinator
323-877-7951

Roski Eye Institute, Keck School of Medicine, USC
Los Angeles, California 90033
Contact:
Coordinator
323-442-3689

Alliance Research Institute - Lynwood
Lynwood, California 90262
Contact:
Coordinator
951-283-3402

A.P.J. Office
Newport Beach, California 92660
Contact:
Coordinator
949-423-9734

Byers Eye Institute at Stanford University
Palo Alto, California 94303
Contact:
Coordinator
559-856-4925

Pasadena Clinical Trials
Pasadena, California 91101
Contact:
Coordinator
626-822-6556

Senta Clinic
San Diego, California 92108
Contact:
Coordinator
619-810-1275

Ilumina Medical Research
Kissimmee, Florida 34744
Contact:
Coordinator
407-807-6506

Med-Care Research
Miami, Florida 33125
Contact:
Coordinator
786-534-3806

Hype Clinical Research LLC
Miami, Florida 33145
Contact:
Coordinator
305-833-0053

Anmed Health Services LLC
Miami, Florida 33193
Contact:
Coordinator
786-536-7156

Sarasota Retina Institute
Sarasota, Florida 34239
Contact:
Coordinator
941-921-5335

Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328
Contact:
Coordinator
404-419-7881

Vision Medical Research
Orland Park, Illinois 60462
Contact:
Coordinator
937-727-7598

Opthalmic Consultants of Boston
East Weymouth, Massachusetts 02189
Contact:
Study Coordinator
617-314-1837

Fraser Eye Care Center
Fraser, Michigan 48026
Contact:
Study Coordinator
586-296-7250

Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan 48152
Contact:
Coordinator
734-608-4167

University Health
Kansas City, Missouri 64108
Contact:
Coordinator
816-218-2582

S.L. Office
Las Vegas, Nevada 89144
Contact:
Coordinator
323-961-5427

Vector Clinical Trials
Sparks, Nevada 89436
Contact:
Coordinator
775-877- 9777

Rutgers New Jersey Medical School
Newark, New Jersey 07103
Contact:
Coordinator
973-972-5435

Asheville Clinical Research
Asheville, North Carolina 28803
Contact:
Coordinator
828-579-2273

Baylor College of Medicine/Alkek Eye Center
Houston, Texas 77030
Contact:
Coordinator
713-798-7692

Gulf Coast Clinical Trials
Houston, Texas 77070
Contact:
Coordinator
346-237-5372

Neuro-Eye Clinical Trials
Houston, Texas 77074
Contact:
Coordinator
713-560-4918

University of Washington, Eye institute
Seattle, Washington 98104
Contact:
Coordinator
206-520-9655

West Virginia University Eye Institute
Morgantown, West Virginia 26506
Contact:
Coordinator
304-598-6977

More Details

NCT ID
NCT06625411
Status
Recruiting
Sponsor
Viridian Therapeutics, Inc.

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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