A Study of VV-14305 for the Treatment of Thyroid Eye Disease

Conditions

• Thyroid Eye Disease (TED)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• VV-14305 — GENETIC
  VV-14305 will be administered via peribulbar injection.
• Sham (No Treatment) — OTHER
  Sham solution such as Saline

Study Details

The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).

Key Dates

First listed

Feb 11, 2026

Start date

May 1, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2029

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Part 1: Safety and Tolerability of VV-14305 in participants with TED [ Time Frame: 52 Weeks ]

Central Contacts

• VP, Medical Affairs
  984-884-5058
  [email protected]

Locations (3)

Find similar trials in Livonia, MI

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