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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Eye Disease (TED)
• Intervention / Treatment: Genetic: VV-14305; Other: Sham (No Treatment)

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: VP, Medical Affairs; Phone Number: 984.884.5058; Email: clinicaltrials@kriyatx.com

Study Locations

• New Zealand
  • New Zealand
    • Auckland, New Zealand, New Zealand
      • Kriya Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be 18 to 80 years of age (inclusive) at Screening.
2. Body Mass Index (BMI) of 19 to 34 kg/m2 (inclusive).
3. Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state).
4. 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.
5. Must be willing and able to cease product use prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug (NSAIDs), medications or any herbal supplements, vitamins, or multivitamins with antiplatelet/anticoagulant properties.
6. 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.
7. Participants must be diagnosed with TED prior to Screening and be diagnosed with Graves' disease and progressive moderate to severe TED at Screening.

Exclusion Criteria:

1. 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 conditions, optic neuropathy, tumors, glaucoma with visual field defect or visual field loss, that in the opinion of the Investigator and/or Medical Monitor is clinically significant.
2. 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 Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate.
3. Diagnosed with diabetes (HbA1c ≥6.5%).
4. 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 intraepithelial neoplasia, and localized prostate cancer.
5. Known allergy or condition that would contraindicate the use of required study medications.
6. 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.
7. Any vaccination or planned vaccination 30 days prior to dosing, 4 weeks post dosing or during period of immunosuppression.
8. 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 orbital decompression, strabismus surgery and any eyelid surgery on either eye.
9. Prior participation in other gene therapy, investigational drug, biologic or device clinical trials within 30 days prior to Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Cohort 1, low dose; A single low dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.	Genetic: VV-14305; VV-14305 will be administered via peribulbar injection.
Experimental: Part 1 Cohort 2, mid dose; A single mid dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.	Genetic: VV-14305; VV-14305 will be administered via peribulbar injection.
Experimental: Part 1 Cohort 3, high dose; A single high dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.	Genetic: VV-14305; VV-14305 will be administered via peribulbar injection.
Experimental: Part 1 Optional Cohort 4, Part 2 dose; A single dose of VV-14305 determined from Cohorts 1, 2, and 3 will be administered. In addition, prednisone will be administered prior to and after VV-14305.	Genetic: VV-14305; VV-14305 will be administered via peribulbar injection.
Experimental: Part 2 Treatment Arm; A single dose of VV-14305 determined from Cohorts 1, 2, and 3 will be administered. In addition, prednisone will be administered prior to and after VV-14305.	Genetic: VV-14305; VV-14305 will be administered via peribulbar injection.
Sham Comparator: Part 2 Sham Arm; A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection.	Other: Sham (No Treatment); Sham solution such as Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Safety and Tolerability of VV-14305 in participants with TED	Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations	52 Weeks
Part 2: Safety of VV-14305 in Participants with TED Compared to Sham	Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations	36 Weeks
Part 2: Efficacy of VV-14305 in participants with TED compared to Sham	Percentage of participants with reduction in proptosis in the study eye as measured by exophthalmometer	36 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Efficacy associated with VV-14305 in participants with TED	Percentage of participants with reduction in proptosis in the study eye as measured by exophthalmometer	52 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)	Percentage of participants with Baseline diplopia >0 who have a ≥1 grade reduction	52 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)	Mean change from Baseline in extraocular muscle (EOM) volume within the study eye	52 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)	Mean change from Baseline in EOM inflammation within the study eye	52 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)	Mean change from Baseline in orbital fat volume (FV) within the study eye	52 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)	Percentage of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye	52 Weeks
Effect of VV-14305 on quality of life (as compared to Sham for Part 2)	Mean change from Baseline in overall score in the Graves Orbitopathy Quality of Life (GO-QoL) questionnaire, which includes two subscales: Visual Functioning and Appearance (scale range 0-100), where higher scores indicate better quality of life	52 Weeks
Pharmacokinetics (PK) of VV-14305 transgene product	Peak and steady-state concentrations of adeno-associated virus (AAV) vector-mediated transgene product in serum	52 Weeks

Collaborators and Investigators

• Sponsor: Kriya Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy; salicylhydroxamic acid
• Other Study ID Numbers: KRIYA-586-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes