A Phase 1/2 interventional study of VV-14305 and Sham (No Treatment) in Thyroid Eye Disease (TED), sponsored by Kriya Therapeutics, Inc.. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Kriya Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's planned enrollment of 135 is above the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Kriya Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Genetic: VV-14305
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Genetic: VV-14305
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Genetic: VV-14305
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Genetic: VV-14305
A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.
Genetic: VV-14305
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.
Genetic: VV-14305
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.
Genetic: VV-14305
A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection
Other: Sham (No Treatment)
VV-14305 will be administered via peribulbar injection.
Sham solution such as Saline
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
Time frame: 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
Time frame: 52 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
Time frame: 36 Weeks
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
Time frame: 36 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
Time frame: 36 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
Time frame: 36 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
Time frame: 36 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
Time frame: 36 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
Time frame: 36 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
Time frame: 12, 24, 36, and 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
Time frame: 12, 24, 36, and 52 Weeks
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Aug 2028, 27 months after the start.
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