Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar

Study Overview
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Brief Summary
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The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).

Official Title
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A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar

Conditions
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Vocal Fold Scar

Intervention / Treatment
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* Drug: KP-100LI
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years to 75 years Presence of bilateral vocal fold scar or sulcus diagnosed No other vocal lesion or vocal movement disorder Voice Handicap Index-10 (VHI-10) score of 11 or higher No laryngoplasty, collagen or lipid infusion to vocal cord, removal scar, fascial graft, or administration of steroid or hyaluronic acid to vocal cord Exclusion Criteria: No movement disorders of the vocal fold including paralysis Airway disease caused by burn History of malignant tumor History of allergy to local anesthesia agent With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs Serious concomitant disease Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KP-100LI<br>Intracordal injection, 20 mcg once per week, 3 weeks | Drug: KP-100LI<br>* Intracordal injection, 20 mcg once per week, 3 weeks<br>* Other names: HGF;|
| Placebo Comparator: Placebo<br>Intracordal injection, once per week, 3 weeks | Drug: Placebo<br>* Intracordal injection, once per week, 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate in VHI-10 score from just before the first administration (baseline at 0 week) to 4, 8, and 12 weeks of the observational period |  | up to 12 weeks | 
| Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period |  | up to 24 weeks | 
| Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period |  | up to 24 weeks | 
| Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observational period |  | up to 24 weeks | 
| Evaluation of adverse events |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocyte Growth Factor, HGF, KP-100LI, KP-100, intracordal injection