A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
- Conditions
- Thyroid eye disease
- Registration Number
- 2023-507563-19-00
- Lead Sponsor
- Viridian Therapeutics Inc.
- Brief Summary
To confirm the safety and tolerability of VRDN-001 when given as 5 intravenous (IV) infusions of 10 mg/kg every three weeks in participants with TED of any duration.
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Not specified
- Target Recruitment
- 155
Be an adult male or female participant, >18 to ≤75 years of age
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
If female, have a negative serum pregnancy test at screening and further negative urine tests immediately before each dose of study medication and following the last dose of study medication
Be surgically sterile males for at least 6 weeks prior to the first dose of VRDN-001, or agree to use an acceptable method of contraception such as a condom and a second highly effective method of contraception
Have received prior treatment with another anti-IGF-1R therapy
Be a pregnant or lactating woman
Have used systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to the first dose of study medication (topical steroids including eye drops or multivitamins that contain selenium are permitted). Also exclusionary is periocular (including intraorbital) or intraocular administration of corticosteroids within 3 months prior to the first dose of study medication or having received greater than 3 periocular or intraocular corticosteroid injections at any time
Have received other immunosuppressive agents, including rituximab, tocilizumab, secukimumab, satralizumab or anti-FcRn’s for any condition (including TED) within 8 weeks prior to the first dose of study medication or have received intraorbital administration of other such immunosuppressive agents at any time
Have received any other therapy for TED within 8 weeks prior to the first dose of study medication (artificial tears are permitted)
Have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye’s orbit
Have a pre-existing ophthalmic condition in the study eye which in the opinion of the Investigator, would confound interpretation of the study results
Have abnormal baseline audiometry Pure Tone Average (PTA) assessment or history of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss
Have inflammatory bowel disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Event (TEAE) incidence rate through Week 15 Treatment Emergent Adverse Event (TEAE) incidence rate through Week 15
- Secondary Outcome Measures
Name Time Method Change from baseline in proptosis in the study eye as measured by exophthalmometer Week 15 Treatment Emergent Adverse Event (TEAE) incidence rate Week 52
Trial Locations
- Locations (19)
Stichting Amsterdam UMC
🇳🇱Amsterdam, Netherlands
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
🇵🇱Wroclaw, Poland
Santa Sp. z o.o.
🇵🇱Lodz, Poland
Oculomedica Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
🇵🇱Warsaw, Poland
Quinze-Vingts National Ophthalmology Hospital
🇫🇷Paris, France
Centre Hospitalier Universitaire De Nice
🇫🇷Nice, France
Centre Hospitalier Regional D'Angers
🇫🇷Angers, France
Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
🇩🇪Mainz, Germany
Scroll for more (9 remaining)Stichting Amsterdam UMC🇳🇱Amsterdam, NetherlandsPeerooz SaeedSite contact0031205669111p.saeed@amsterdamumc.nl