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 Details
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)
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
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)
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: VRDN-001 10 mg/kg Drug: 5 Infusions of VRDN-001 10 mg/kg |
Drug: VRDN-001 10 mg/kg Drug:
Drug: 5 Infusions of VRDN-001 10mg/ Placebo: 5 Infusions of placebo
|
Experimental: Placebo Drug Placebo Drug: 5 Infusions of placebo |
Drug: VRDN-001 10 mg/kg Drug:
Drug: 5 Infusions of VRDN-001 10mg/ Placebo: 5 Infusions of placebo
|
Outcome Measures
Primary Outcome Measures
- Proptosis Responder Rate in the study eye [3 weeks post the fifth infusion]
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 [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 [Week 15]
Clinical Activity Responder Rate in the study eye
- Change from baseline in CAS in the study eye [Week 15]
Change from baseline in CAS in the study eye
- Overall Response Rate in the study eye [Week 15]
Overall Response Rate in the study eye
- Diplopia Resolution Rate [Week 15]
Diplopia Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score >0) at Week 15
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began > 15 months prior to screening
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Must have Clinical Activity Score (CAS) of (0-7) item scale for the study (more proptotic) eye
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Must agree to use highly effective contraception as specified in the protocol
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Female TED participants must have a negative serum pregnancy test
Key Exclusion Criteria:
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Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
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Must not have used oral corticosteroids within 2 weeks prior to Day 1
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Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
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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
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Must not have had previous orbital irradiation or surgery for TED in the study eye
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Must not have a history inflammatory bowel disease
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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
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Must not have received an investigational agent for any condition
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Female TED participants must not be pregnant or lactating
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Viridian Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VRDN-001-301