Not Yet RecruitingPhase 1/2

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

New Zealand110 participantsStarted 2026-02

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Must be 18 to 80 years of age (inclusive) at Screening.
✓. Body Mass Index (BMI) of 19 to 34 kg/m2 (inclusive).
✓. 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 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.
✓. 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 TED prior to Screening and be diagnosed with Graves' disease and progressive moderate to severe TED at Screening.

Exclusion criteria

✕. 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.
✕. 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.
✕. 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 intraepithelial neoplasia, and localized prostate cancer.
✕. 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 orbital decompression, strabismus surgery and any eyelid surgery on either eye.

What they're measuring

Part 1: Safety and Tolerability of VV-14305 in participants with TED

Timeframe: 52 Weeks

Part 2: Safety of VV-14305 in Participants with TED Compared to Sham

Timeframe: 36 Weeks

Part 2: Efficacy of VV-14305 in participants with TED compared to Sham

Timeframe: 36 Weeks

Trial details

NCT IDNCT07404111

SponsorKriya Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

VP, Medical Affairs

984.884.5058 clinicaltrials@kriyatx.com

View on ClinicalTrials.gov More Thyroid Eye Disease (TED) trials