Clinical trial NCT06812325: A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
Official title: A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thyroid Eye Disease (TED)
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: 2025-02-06
Enrollment: 284
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: Participants will be randomized to one of the two study arms.
Primary purpose: TREATMENT

Brief summary: This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with 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), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with 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 VRDN-003
* Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening

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 for any condition, including TED, or any other therapy for TED within 8 weeks prior to first dose
* Must not have received an investigational agent for any condition, including 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 had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
* Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
* 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 a history of inflammatory bowel disease
* Female TED participants must not be pregnant or breastfeeding

Primary outcomes:
measure: Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer
timeFrame: Week 24
measure: TEAE incidence rate through Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Catalina Eye Care
state: Arizona
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group INC
state: California
city: Santa Maria
country: United States
facility: FOMAT Medical Research
state: California
city: Cape Coral
country: United States
facility: C A Clinical Trial Corp.
state: Florida
city: Coral Gables
country: United States
facility: Herco Medical and Research Center
state: Florida
city: Doral
country: United States
facility: D H Doral Research Center
state: Florida
city: Homestead
country: United States
facility: Sina Medical Center
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Miami
country: United States
facility: Southern Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: Retreat Medical Research
state: Florida
city: Miami
country: United States
facility: Continental Clinical Research
state: Florida
city: Plantation
country: United States
facility: Edward Jenner Research Group LLC
state: Florida
city: East Weymouth
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Carrollton
country: United States
facility: DFW Clinical Trials
state: Texas
city: Houston
country: United States
facility: Neuro Eye Clinical Trials
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc.
state: Texas
city: Seabrook
country: United States
facility: Elevate Clinical Research
state: Texas
Study officials:
References: