Health TrialsbyHealthPanel

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

ConditionThyroid Eye Disease (TED)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKriya Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VV-14305

    Genetic

    VV-14305 will be administered via peribulbar injection.

  • Sham (No Treatment)

    Other intervention

    Sham solution such as Saline

Treatment groups

135 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1 Cohort 1, dose #1Experimental treatment 1 intervention
Group B: Part 1 Cohort 2, dose #2Experimental treatment 1 intervention
Group C: Part 1 Cohort 3, dose #3Experimental treatment 1 intervention
Group D: Part 1 Cohort 4, dose #4Experimental treatment 1 intervention
Group E: Part 1 Cohort 5, dose #5Experimental treatment 1 intervention
Group F: Part 1 Optional Cohort 6, Part 2 doseExperimental treatment 1 intervention
Group G: Part 2 Treatment ArmExperimental treatment 1 intervention
Group H: Part 2 Sham ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kriya Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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