Clinical trial NCT06021054: An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2)
Official title: A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of Veligrotug (VRDN-001), a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic 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
TED
Lead sponsor: Viridian Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 188
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: The study will be comprised of approximately 159 participants randomized to either 5 IV infusions of 10 mg/kg veligrotug (VRDN-001) administered at 3-week intervals or placebo IV infusions administered at 3-week intervals.
Primary purpose: TREATMENT

Brief summary: This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).

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 chronic TED. The key objectives of this study are to determine if veligrotug (VRDN-001) is efficacious, safe, and tolerable when administered as 5 IV infusions given every 3 weeks for a total of 12 weeks in participants with chronic TED

Eligibility criteria: Key Inclusion Criteria:

* Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
* Must have had a clinical diagnosis of TED, with any CAS (0-7)
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria:

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
* Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks prior to first dose
* Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
* Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results
* Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
* Must not have a history of inflammatory bowel disease
* Must not have an abnormal hearing test before first dose or history of ear conditions considered clinically significant by the study doctor
* Female TED participants must not be pregnant or lactating

Primary outcomes:
measure: Proptosis Responder Rate in the most proptotic eye
timeFrame: Week 15
Secondary outcomes:
measure: Change from baseline in proptosis in the most proptotic eye
timeFrame: Week 15
measure: Clinical Activity Responder Rate in the most proptotic eye
timeFrame: Week 15
measure: Overall Responder Rate in the most proptotic eye
timeFrame: Week 15
measure: Diplopia Responder Rate
timeFrame: Week 15
measure: Diplopia Resolution Rate
timeFrame: Week 15
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Advancing Research International, LLC
state: California
city: Los Angeles
country: United States
facility: USC Roski Eye Institute
state: California
city: Newport Beach
country: United States
facility: Amy Patel Jain, MD
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: Miami
country: United States
facility: Bascom Palmer Eye Institute - Ophthalmology - Miami
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Oak Lawn
country: United States
facility: Family Eye Physicians, Ltd
state: Illinois
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University, Department of Neurology
state: Michigan
city: Livonia
country: United States
facility: Kahana Oculoplastic and Orbital Surgery
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine in St Louis - Ophthalmology
state: Missouri
city: Las Vegas
country: United States
facility: Steven Leibowitz, MD.
state: Nevada
city: Newark
country: United States
facility: Rutgers - New Jersey Medical School
state: New Jersey
city: Somerset
country: United States
facility: The Center for Eye and Facial Plastic Surgery
state: New Jersey
city: Philadelphia
country: United States
facility: Department of Ophthalmology, University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
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: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Saint Leonards
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Saint-André
city: Nantes
country: France
facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec
city: Nice
country: France
facility: CH Nice
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin KöR
city: Essen
country: Germany
facility: Universitätsklinikum Essen AöR
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Budapest
country: Hungary
facility: Budapest Retina Intezet
city: Pécs
country: Hungary
facility: Ganglion Orvosi Kozpont
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Białystok
country: Poland
facility: Oculomedica Sp. z o.o.
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki Sp. z o.o.
city: Piaseczno
country: Poland
facility: Centrum Medyczne Pulawska Sp. z o.o.
city: Wałbrzych
country: Poland
facility: Centrum Medyczne Piasta 47 sp. z o.o.
city: Barcelona
country: Spain
facility: Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)
city: Coruña
country: Spain
facility: Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
city: Córdoba
country: Spain
facility: Hospital La Arruzafa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen De La Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valence
country: Spain
facility: Hospital Universitario Y Politécnico La Fe
city: Zaragoza
country: Spain
facility: Hospital Unviersitario Miguel Servet
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty Hospital
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Medicine
city: London
country: United Kingdom
facility: Moorfield&#39;s Eye Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Western eye Hospital
city: London
country: United Kingdom
facility: Guy&#39;s and St. Thomas NHS Trust
city: Newcastle
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
References: