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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06021054




Registration number
NCT06021054
Ethics application status
Date submitted
25/08/2023
Date registered
1/09/2023
Date last updated
27/09/2024

Titles & IDs
Public title
An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants with Chronic Thyroid Eye Disease (TED) (THRIVE-2)
Scientific 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)
Secondary ID [1] 0 0
VRDN-001-301
Universal Trial Number (UTN)
Trial acronym
THRIVE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Eye Disease 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Veligrotug (VRDN-001)
Treatment: Drugs - Placebo

Experimental: Veligrotug (VRDN-001)10 mg/kg - Drug: 5 IV Infusions of veligrotug (VRDN-001)10 mg/kg

Experimental: Placebo Drug - Placebo Drug: 5 IV Infusions of placebo


Treatment: Drugs: Veligrotug (VRDN-001)
Veligrotug (VRDN-001) is a humanized monoclonal antibody directed against the IGF-1 receptor

Treatment: Drugs: Placebo
5 IV infusions of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proptosis Responder Rate in the most proptotic eye
Timepoint [1] 0 0
Week 15
Secondary outcome [1] 0 0
Change from baseline in proptosis in the most proptotic eye
Timepoint [1] 0 0
Week 15
Secondary outcome [2] 0 0
Clinical Activity Responder Rate in the most proptotic eye
Timepoint [2] 0 0
Week 15
Secondary outcome [3] 0 0
Overall Responder Rate in the most proptotic eye
Timepoint [3] 0 0
Week 15
Secondary outcome [4] 0 0
Diplopia Responder Rate
Timepoint [4] 0 0
Week 15
Secondary outcome [5] 0 0
Diplopia Resolution Rate
Timepoint [5] 0 0
Week 15

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
North Shore Private Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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Michigan
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Missouri
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Nevada
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New Jersey
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Washington
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France
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Angers
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France
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Bordeaux
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France
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Nantes
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France
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Nice
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Germany
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Berlin
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Göttingen
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Hungary
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Budapest
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Hungary
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Pécs
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Italy
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Milano
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Italy
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Pisa
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Poland
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Bialystok
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Poland
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Gdansk
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Poland
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Piaseczno
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Poland
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Walbrzych
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Spain
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Barcelona
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Spain
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Coruña
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valence
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Spain
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Zaragoza
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Istanbul
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United Kingdom
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London
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United Kingdom
State/province [40] 0 0
Newcastle
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United Kingdom
State/province [41] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Viridian Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06021054
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06021054