A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Viridian Therapeutics, Inc.
- Enrollment
- 320
- Locations
- 124
- Primary Endpoint
- Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Participant, Site personnel (except pharmacy personnel preparing the injection), and Sponsor are masked.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 or steroid eye drops 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 12 weeks prior to first dose
- •Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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
Arms & Interventions
VRDN-003 every 8 weeks
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Intervention: VRDN-003 (Drug)
VRDN-003 every 4 weeks
6 subcutaneous administrations of VRDN-003
Intervention: VRDN-003 (Drug)
VRDN-003 every 8 weeks
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Time Frame: Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Secondary Outcomes
- Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer(Week 24)
- TEAE incident rate through study completion(Week 52)