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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06384547




Registration number
NCT06384547
Ethics application status
Date submitted
22/04/2024
Date registered
25/04/2024

Titles & IDs
Public title
A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants with Thyroid Eye Disease (TED)
Scientific 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)
Secondary ID [1] 0 0
VRDN-001-303
Universal Trial Number (UTN)
Trial acronym
STRIVE
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 - VRDN-001 10 mg/kg
Treatment: Drugs - VRDN-001 3 mg/kg

Experimental: VRDN-001 10 mg/kg - 5 infusions of VRDN-001 10 mg/kg

Experimental: 5 infusions of VRDN-001 3 mg/kg - 5 infusions of VRDN-001 3 mg/kg


Treatment: Drugs: VRDN-001 10 mg/kg
5 infusions of VRDN-001 10 mg/kg

Treatment: Drugs: VRDN-001 3 mg/kg
5 infusions of VRDN-001 3 mg/kg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Emergent Adverse Event (TEAE) incidence rate
Timepoint [1] 0 0
Week 15
Secondary outcome [1] 0 0
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15
Timepoint [1] 0 0
Week 15
Secondary outcome [2] 0 0
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 52
Timepoint [2] 0 0
Week 52

Eligibility
Key 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
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 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

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 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
23/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
North Shore Eye Surgery - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Vermont
Country [14] 0 0
United States of America
State/province [14] 0 0
West Virginia
Country [15] 0 0
France
State/province [15] 0 0
Angers
Country [16] 0 0
France
State/province [16] 0 0
Des Quinze Vingts Paris
Country [17] 0 0
France
State/province [17] 0 0
Nice
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
Germany
State/province [19] 0 0
Göttingen
Country [20] 0 0
Germany
State/province [20] 0 0
Mainz
Country [21] 0 0
Poland
State/province [21] 0 0
Bialystok
Country [22] 0 0
Poland
State/province [22] 0 0
Bydgoszcz
Country [23] 0 0
Poland
State/province [23] 0 0
Lódz
Country [24] 0 0
Poland
State/province [24] 0 0
Warszawa
Country [25] 0 0
Poland
State/province [25] 0 0
Wroclaw
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Córdoba
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Pamplona
Country [30] 0 0
Spain
State/province [30] 0 0
Santiago de Compostela, A Coruña
Country [31] 0 0
Spain
State/province [31] 0 0
Sevilla
Country [32] 0 0
Spain
State/province [32] 0 0
Zaragoza
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06384547