Clinical trial for Thyroid Eye Disease (TED)
Official title A Study of VV-14305 for the Treatment of Thyroid Eye Disease
ClinicalTrials.gov ID: NCT07404111
What this study is testing
What is VV-14305?
VV-14305 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for thyroid eye disease (ted).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Must be 18 to 80 years of age (inclusive) at Screening.
- Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid...
- Best Corrected Visual Acuity (BCVA) score of 20/60 or better at Screening with no history of deterioration noted in the 3 months prior to Screening.
- Must be willing and able to cease product use 10 Days prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug...
- The study eye and the fellow eye must fall within the pre-defined degree of proptosis and clinical activity score (CAS) as measured at Screening.
You likely can't join if
- History of serious ocular condition(s) other than TED, including but not limited to uveitis, dry age-related macular degeneration (AMD), and wet AMD...
- Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug...
- Diagnosed with diabetes (HbA1c ≥6.5%).
- History of malignancy requiring chemotherapy and/or radiation in the 12 months prior to Screening, except for successfully treated nonmelanoma skin...
- Known allergy or condition that would contraindicate the use of required study medications.
- Any Screening assessment or laboratory value that, in the opinion of the Investigator and/or Medical Monitor, is clinically significant and renders...
See the full eligibility criteria
- Must be 18 to 80 years of age (inclusive) at Screening.
- Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state).
- Best Corrected Visual Acuity (BCVA) score of 20/60 or better at Screening with no history of deterioration noted in the 3 months prior to Screening.
- Must be willing and able to cease product use 10 Days prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug (NSAIDs), antiplatelet/anticoagulant medications or any herbal...
- The study eye and the fellow eye must fall within the pre-defined degree of proptosis and clinical activity score (CAS) as measured at Screening.
- Participants must be diagnosed with chronic moderate to severe TED at Screening.
- History of serious ocular condition(s) other than TED, including but not limited to uveitis, dry age-related macular degeneration (AMD), and wet AMD; Other orbital or ophthalmic diseases, including inflammatory...
- Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month...
- Diagnosed with diabetes (HbA1c ≥6.5%).
- History of malignancy requiring chemotherapy and/or radiation in the 12 months prior to Screening, except for successfully treated nonmelanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical...
- Known allergy or condition that would contraindicate the use of required study medications.
- Any Screening assessment or laboratory value that, in the opinion of the Investigator and/or Medical Monitor, is clinically significant and renders the subject not suitable for study participation.
- Any vaccination or planned vaccination 30 days prior to dosing, 4 weeks post dosing or during period of immunosuppression.
- Participant requires or, in the opinion of the Investigator, is likely to require immediate surgical ophthalmological/orbital intervention or irradiation of either eye; has had any prior surgery for TED including...
- Prior participation in other investigational drug, biologic or device clinical trials within 30 days prior to Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Livonia, Michigan, United States
- Las Vegas, Nevada, United States
- Erie, Pennsylvania, United States
- Auckland, New Zealand
- Wellington, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Livonia, Michigan, United States; Las Vegas, Nevada, United States; Erie, Pennsylvania, United States; Auckland, New Zealand; Wellington, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.