An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
Purpose
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED).
Condition
- Thyroid Eye Disease
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening - Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye - 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 who must not be pregnant or breastfeeding NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized to one of the three study arms.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- Participants, Investigator, Outcomes Assessor and Sponsor will be masked.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VRDN-003 every 4 weeks |
6 subcutaneous administrations of VRDN-003 |
|
|
Experimental VRDN-003 every 8 weeks |
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo |
|
|
Placebo Comparator Placebo every 4 weeks |
6 subcutaneous administrations of placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT06625411
- Status
- Active, not recruiting
- Sponsor
- Viridian Therapeutics, Inc.
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), placebo-controlled study that will include participants with active TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/SC injections given every 4 weeks or every 8 weeks compared to placebo in participants with active TED. Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.