Clinical trial NCT06384547: A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants with Thyroid Eye Disease (TED)
Official title: A Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants with Thyroid Eye Disease (TED)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: 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
Lead sponsor: Viridian Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).
Primary purpose: TREATMENT

Brief summary: The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.

Detailed description: A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).

Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of TED with or without proptosis and with any CAS (0 - 7) and in the opinion of the investigator may benefit from treatment
* Must agree to use highly effective contraception method as specified in the protocol
* Female TED participants must have a negative serum pregnancy test
* Not require immediate ophthalmological or orbital surgery in the study eye for any reason

Exclusion Criteria:

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have used systemic corticosteroids, or selenium 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 received any other therapy for TED within 8 weeks prior to Day 1
* Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
* 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 decompression surgery involving excision of fat for TED in the study eye's orbit
* Must not have inflammatory bowel disease
* 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 received an investigational agent for any condition within 8 weeks prior to Day 1
* Female TED participants must not be pregnant or lactating

Primary outcomes:
measure: Treatment Emergent Adverse Event (TEAE) incidence rate
timeFrame: Week 15
Secondary outcomes:
measure: Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15
timeFrame: Week 15
measure: Treatment Emergent Adverse Event (TEAE) incidence rate through Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Advancing Research International, LLC
state: California
city: Palo Alto
country: United States
facility: Stanford Byers Eye Institute
state: California
city: San Diego
country: United States
facility: Cockerham Eye Consultants, PC
state: California
city: Santa Maria
country: United States
facility: FOMAT Medical Research
state: California
city: Aurora
country: United States
facility: University of Colorado - Dept of Ophthalmology
state: Colorado
city: Homestead
country: United States
facility: Sina Medical Center LLC
state: Florida
city: Miami
country: United States
facility: Med-Care Research Inc.
state: Florida
city: Plantation
country: United States
facility: Edward Jenner Research Group Center LLC
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Orland Park
country: United States
facility: Vision Medical Research Inc.
state: Illinois
city: Kansas City
country: United States
facility: University Health Diabetes, Endocrinology & Nephrology Center
state: Kansas
city: Kansas City
country: United States
facility: KU Medical Center, University of Kansas
state: Kansas
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Weymouth
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Fraser
country: United States
facility: Fraser Eye Care Center
state: Michigan
city: Livonia
country: United States
facility: Kahana Oculoplastic & Orbital Surgery
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Ophthalmology and Visual Neurosciences
state: Minnesota
city: Las Vegas
country: United States
facility: Advancing Research International, LLC
state: Nevada
city: Newark
country: United States
facility: Rutgers- New Jersey Medical School- Newark
state: New Jersey
city: New York
country: United States
facility: New York Eye Ear Infirmary of Mount Sinai
state: New York
city: Houston
country: United States
facility: Baylor College of Medicine (BCM) - Ophthalmology
state: Texas
city: Houston
country: United States
facility: Neuro-Eye Clinical Trials
state: Texas
city: Houston
country: United States
facility: Neuro-Ophthalmology of Texas, PLLC
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
city: Sydney
country: Australia
facility: Sydney Eye Hospital
city: Sydney
country: Australia
facility: North Shore Eye Surgery
city: Angers
country: France
facility: CHU d'Angers
city: Des Quinze Vingts Paris
country: France
facility: Centre Hospitalier National D'ophtalmologie
city: Nice
country: France
facility: CH Nice
city: Paris
country: France
facility: AP-HP - Hôpital de la Pitié Salpétrière
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Mainz
country: Germany
facility: Johannes Gutenberg-University Medical Center
city: Bialystok
country: Poland
facility: NZOZ E-Vita
city: Bydgoszcz
country: Poland
facility: Specjalistyczny Osrodek Okulistyczny Oculomedica
city: Lódz
country: Poland
facility: Santa Familia PTG Lodz
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
city: Barcelona
country: Spain
facility: Clinica Bonanova de Cirugia Ocular
city: Córdoba
country: Spain
facility: Hospital Arruzafa
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santiago de Compostela, A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen De La Macarena, Servicio de Oftalmología
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital, Clinical Trials Unit
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: Western Eye Hospital, Imperial College NHS Trust
city: London
country: United Kingdom
facility: Guy's and St. Thomas NHS Trust
Study officials:
References: