KRIYA-586 (VV-14305) for Thyroid Eye Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-phase, interventional study evaluating VV-14305 for safety, tolerability, and efficacy in moderate to severe TED. Participants may receive VV-14305 or a sham procedure to compare effects. Eligible adults undergo eye measurements and disease activity assessments, and must pause certain medications around injections. The trial is conducted at three U.S. sites operated by Kriya Therapeutics. Primary outcomes focus on safety and changes in eye-related symptoms and function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Must be 18 to 80 years of age (inclusive) at Screening.
2. Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state).
3. 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.
4. 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.
5. 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.
6. Participants must be diagnosed with chronic 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 investigational drug, biologic or device clinical trials within 30 days prior to Screening.

Where it's running

• Kriya Clinical Trial Site
  Livonia, Michigan, United States Recruiting
• Kriya Clinical Trial Site
  Las Vegas, Nevada, United States Recruiting
• Kriya Clinical Trial Site
  Erie, Pennsylvania, United States Recruiting
• Kriya Clinical Trial Site
  Auckland, New Zealand Recruiting
• Kriya Clinical Trial Site
  Wellington, New Zealand Recruiting

Study contacts

• Study coordinator: VP, Medical Affairs
• Email: clinicaltrials@kriyatx.com
• Phone: 984-884-5058

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Linsitinib in moderate to severe Thyroid Eye Disease (TED)

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• MHB018A injections for chronic moderate-to-severe thyroid eye disease

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• Cizutamig in thyroid eye disease for adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.