Back to resultsA Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
Primary Purpose
Thyroid Eye Disease
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VRDN-001 10 mg/kg Drug:
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Graves, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy
Eligibility Criteria
Inclusion Criteria: Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began > 15 months prior to screening Must have Clinical Activity Score (CAS) of (0-7) item scale for the study (more proptotic) eye Must agree to use highly effective contraception as specified in the protocol Female TED participants must have a negative serum pregnancy test Key Exclusion Criteria: Must not have received prior treatment with another anti-IGF-1R monoclonal antibody Must not have used oral corticosteroids within 2 weeks prior to Day 1 Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1 Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results Must not have had previous orbital irradiation or surgery for TED in the study eye Must not have a history inflammatory bowel disease Must not have a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss Must not have received an investigational agent for any condition Female TED participants must not be pregnant or lactating
Sites / Locations
- Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VRDN-001 10 mg/kg
Placebo Drug
Arm Description
Drug: 5 Infusions of VRDN-001 10 mg/kg
Placebo Drug: 5 Infusions of placebo
Outcomes
Primary Outcome Measures
Proptosis Responder Rate in the study eye
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥2 mm from baseline [without a corresponding increase of ≥2 mm in the fellow eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e., Week 15)
Secondary Outcome Measures
Change from Baseline in proptosis in the study eye at Week 15
Change from Baseline in proptosis in the study eye as measured by exophthalmometer at Week 15
Clinical Activity Responder Rate in the study eye
Clinical Activity Responder Rate in the study eye
Change from baseline in CAS in the study eye
Change from baseline in CAS in the study eye
Overall Response Rate in the study eye
Overall Response Rate in the study eye
Diplopia Resolution Rate
Diplopia Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score >0) at Week 15
Full Information
NCT ID
NCT06021054
First Posted
August 25, 2023
Last Updated
October 12, 2023
Sponsor
Viridian Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06021054
Brief Title
A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
Official Title
A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viridian Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001 in participants with chronic thyroid eye disease (TED)
Detailed Description
A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with chronic thyroid eye disease (TED)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease
Keywords
Graves, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VRDN-001 10 mg/kg
Arm Type
Experimental
Arm Description
Drug: 5 Infusions of VRDN-001 10 mg/kg
Arm Title
Placebo Drug
Arm Type
Experimental
Arm Description
Placebo Drug: 5 Infusions of placebo
Intervention Type
Drug
Intervention Name(s)
VRDN-001 10 mg/kg Drug:
Intervention Description
Drug: 5 Infusions of VRDN-001 10mg/ Placebo: 5 Infusions of placebo
Primary Outcome Measure Information:
Title
Proptosis Responder Rate in the study eye
Description
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥2 mm from baseline [without a corresponding increase of ≥2 mm in the fellow eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e., Week 15)
Time Frame
3 weeks post the fifth infusion
Secondary Outcome Measure Information:
Title
Change from Baseline in proptosis in the study eye at Week 15
Description
Change from Baseline in proptosis in the study eye as measured by exophthalmometer at Week 15
Time Frame
Week 15
Title
Clinical Activity Responder Rate in the study eye
Description
Clinical Activity Responder Rate in the study eye
Time Frame
Week 15
Title
Change from baseline in CAS in the study eye
Description
Change from baseline in CAS in the study eye
Time Frame
Week 15
Title
Overall Response Rate in the study eye
Description
Overall Response Rate in the study eye
Time Frame
Week 15
Title
Diplopia Resolution Rate
Description
Diplopia Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score >0) at Week 15
Time Frame
Week 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began > 15 months prior to screening
Must have Clinical Activity Score (CAS) of (0-7) item scale for the study (more proptotic) eye
Must agree to use highly effective contraception as specified in the protocol
Female TED participants must have a negative serum pregnancy test
Key Exclusion Criteria:
Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
Must not have used oral corticosteroids within 2 weeks prior to Day 1
Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
Must not have had previous orbital irradiation or surgery for TED in the study eye
Must not have a history inflammatory bowel disease
Must not have a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss
Must not have received an investigational agent for any condition
Female TED participants must not be pregnant or lactating
Facility Information:
Facility Name
Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coordinator
Phone
346-429-4135
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
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