Thyroid Eye Disease (TED)Phase 1/2RECLAIMNCT07404111
A Study of VV-14305 for the Treatment of Thyroid Eye Disease
A Phase 1/2 study testing VV-14305 in people with Thyroid Eye Disease (TED), run by Kriya Therapeutics, Inc. at 5 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Eye Disease (TED)
- What is being tested?
- VV-14305
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 May 2026to Aug 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 to 80 years of age (inclusive) at Screening.
- 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 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.
- 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 chronic moderate to severe TED at Screening.
Who cannot join
- 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.
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- 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.
- Prior participation in other investigational drug, biologic or device clinical trials within 30 days prior to Screening.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Kriya Clinical Trial Site
Erie, Pennsylvania, 16505
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
clinicaltrials@kriyatx.com
- Recruiting
Kriya Clinical Trial Site
Las Vegas, Nevada, 89144
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
- Recruiting
Kriya Clinical Trial Site
Livonia, Michigan, 48152
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
New Zealand2 sites, 2 recruiting
- Recruiting
Kriya Clinical Trial Site
Auckland
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
- Recruiting
Kriya Clinical Trial Site
Wellington
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
About this study
Official title: 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).
- Conditions
- Thyroid Eye Disease (TED)
- Being tested
- VV-14305, Sham (No Treatment)
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV-14305Genetic
VV-14305 will be administered via peribulbar injection.
Sham (No Treatment)Other
Sham solution such as Saline
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1, dose #1 | Experimental | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. Receives: Genetic: VV-14305 |
| Part 1 Cohort 2, dose #2 | Experimental | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. Receives: Genetic: VV-14305 |
| Part 1 Cohort 3, dose #3 | Experimental | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. Receives: Genetic: VV-14305 |
| Part 1 Cohort 4, dose #4 | Experimental | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. Receives: Genetic: VV-14305 |
| Part 1 Cohort 5, dose #5 | Experimental | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. Receives: Genetic: VV-14305 |
| Part 1 Optional Cohort 6, Part 2 dose | Experimental | 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. Receives: Genetic: VV-14305 |
| Part 2 Treatment Arm | Experimental | 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. Receives: Genetic: VV-14305 |
| Part 2 Sham Arm | Experimental | A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 36 Weeks
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12, 24, 36, and 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 May 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease (TED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kriya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404111
- Sponsor's protocol ID
- KRIYA-586-101
- Acronym
- RECLAIM
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07404111
- Acronym / sponsor ID
- RECLAIM / KRIYA-586-101
- Conditions
- Thyroid Eye Disease (TED)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Kriya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1, dose #1 | Experimental | Genetic: VV-14305A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 2, dose #2 | Experimental | Genetic: VV-14305A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 3, dose #3 | Experimental | Genetic: VV-14305A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 4, dose #4 | Experimental | Genetic: VV-14305A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 5, dose #5 | Experimental | Genetic: VV-14305A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Optional Cohort 6, Part 2 dose | Experimental | Genetic: VV-14305A 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. |
| Part 2 Treatment Arm | Experimental | Genetic: VV-14305A 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. |
| Part 2 Sham Arm | Experimental | Other: Sham (No Treatment)A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be 18 to 80 years of age (inclusive) at Screening.
- 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 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.
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VV-14305VV-14305 will be administered via peribulbar injection. | Genetic | Part 1 Cohort 1, dose #1, Part 1 Cohort 2, dose #2, Part 1 Cohort 3, dose #3, Part 1 Cohort 4, dose #4, Part 1 Cohort 5, dose #5, Part 1 Optional Cohort 6, Part 2 dose, Part 2 Treatment Arm |
| Sham (No Treatment)Sham solution such as Saline | Other | Part 2 Sham Arm |
Primary outcome
Part 1: Safety and Tolerability of VV-14305 in participants with TED
Time frame: 52 Weeks
Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations
Part 2: Safety of VV-14305 in Participants with TED Compared to Sham
Time frame: 52 Weeks
Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations
Part 2: Efficacy of VV-14305 in participants with TED compared to Sham
Time frame: 36 Weeks
Percentage of participants with reduction in proptosis in the study eye as measured by exophthalmometer
8 secondary outcomes
Part 1: Efficacy associated with VV-14305 in participants with TED
Time frame: 36 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)
Time frame: 36 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)
Time frame: 36 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)
Time frame: 36 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)
Time frame: 36 Weeks
Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)
Time frame: 36 Weeks
Effect of VV-14305 on quality of life (as compared to Sham for Part 2)
Time frame: 12, 24, 36, and 52 Weeks
Pharmacokinetics (PK) of VV-14305 transgene product
Time frame: 12, 24, 36, and 52 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VV-14305 in people with Thyroid Eye Disease (TED), run by Kriya Therapeutics, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP, Medical Affairs (984-884-5058, clinicaltrials@kriyatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Safety and Tolerability of VV-14305 in participants with TED (time frame: 52 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.