An Adaptive Phase 1/2 MulticenteR Study Evaluating the Safety, Tolerability, Pharmacokinetics and EfficaCy of VV-14305 Delivered Via PeribuLbAr Injection in Patients With Moderate to Severe Thyroid Eye Disease (the RECLAIM Study)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Genetic, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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 supplements, vitamins, or multivitamins with antiplatelet/anticoagulant properties. Product use may resume following the administration of VV-14305 or sham.
• 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.
Locations
United States
Michigan
Kriya Clinical Trial Site
RECRUITING
Livonia
Nevada
Kriya Clinical Trial Site
RECRUITING
Las Vegas
Pennsylvania
Kriya Clinical Trial Site
RECRUITING
Erie
Other Locations
New Zealand
Kriya Clinical Trial Site
RECRUITING
Auckland
Kriya Clinical Trial Site
RECRUITING
Wellington
Contact Information
Primary
VP, Medical Affairs
clinicaltrials@kriyatx.com
984-884-5058
Time Frame
Start Date:2026-05-01
Estimated Completion Date:2029-08
Participants
Target number of participants:135
Treatments
Experimental: Part 1 Cohort 1, dose #1
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Experimental: Part 1 Cohort 2, dose #2
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Experimental: Part 1 Cohort 3, dose #3
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Experimental: Part 1 Cohort 4, dose #4
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Experimental: Part 1 Cohort 5, dose #5
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Experimental: Part 1 Optional Cohort 6, Part 2 dose
A single dose of VV-14305 determined from Cohorts 1 to 5 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Experimental: Part 2 Treatment Arm
A single dose of VV-14305 determined from Cohorts 1 to 5 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Experimental: Part 2 Sham Arm
A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection