An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies

Phase 3

Recruiting

Brief Summary: An open-label study for participants who are non-responders at end of the treatment period assessment (i.e., 15 weeks) in the VRND-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies

Recruitment & Eligibility

Inclusion Criteria

Have completed at least 5 infusions and assessments required to determine proptosis responder status as measured by exophthalmometer 3 weeks post the fifth infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
Been a participant in either the VRDN-001-101 or VRDN-001-301 pivotal studies and found to be non-responder
Must agree to use highly effective contraception as specified in the protocol
Female Thyroid Eye Disease (TED) participants must have a negative urine pregnancy test

Exclusion Criteria

Must not have received prior treatment with another anti-IGF-1R monoclonal antibody or any other investigational agent for TED
Must not have used systemic 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 history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
Must not have received an investigational agent for any condition (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies) within 8 weeks prior to Day 1

Arm && Interventions

Group	Intervention	Description
VRDN-001 10 mg/kg	Intervention/Treatment	5 infusions of VRDN-001 10 mg/kg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Overall Responder Rate in the study eye	Week 15	Overall Responder Rate in the study eye at Week 15
Clinical Activity Responder Rate in the study eye	Week 15	Clinical Activity Responder Rate in the study eye at Week 15
Change from baseline in Clinical Activity Score in the study eye	Week 15	Change from baseline in Clinical Activity Score in the study eye at Week 15
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

Locations (19): MACRO Trials, Inc.
🇺🇸
Los Angeles, California, United States
Rutgers New Jersey Medical School
🇺🇸
Newark, New Jersey, United States
Amy Patel Jain, MD Inc
🇺🇸
Newport Beach, California, United States
Alkek Eye Center
🇺🇸
Houston, Texas, United States
Advancing Research International, LLC
🇺🇸
Los Angeles, California, United States
Roski Eye Institute
🇺🇸
Los Angeles, California, United States
Sarasota Retina Institute
🇺🇸
Sarasota, Florida, United States
Cockerham Eye Consultants, PC
🇺🇸
San Diego, California, United States
Ophthalmic Consultants of Boston
🇺🇸
E. Weymouth, Massachusetts, United States
Kahana Oculoplastic & Orbital Surgery
🇺🇸
Livonia, Michigan, United States
The Center for Eye and Facial Plastic Surgery
🇺🇸
Somerset, New Jersey, United States
Neuro-eye Clinical Trials
🇺🇸
Houston, Texas, United States
Hospital Arruzafa. Servicio de Oftalmologia
🇪🇸
Córdoba, Spain
University of Vermont Medical Center
🇺🇸
Burlington, Vermont, United States
Hospital Universitario Miguel Servel
🇪🇸
Zaragoza, Spain
Byers Eye Institute
🇺🇸
Palo Alto, California, United States
Neuro-Eye Clinical Trials
🇺🇸
Houston, Texas, United States
Hospital Universitario Virgen de la Macarena
🇪🇸
Sevilla, Spain
Vision Medical Research
🇺🇸
Oak Lawn, Illinois, United States