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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Vocal Fold Scar
• Intervention / Treatment: Drug: KP-100LI; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daichika Hayata; Phone Number: +81-6-7653-6728; Email: hayata@kringle-pharma.com
• Study Contact Backup: Name: Hideo Murakami; Phone Number: +81-6-7653-6728; Email: h.murakami@kringle-pharma.com

Study Locations

• Japan
  • Aichi-ken
    • Toyoake, Aichi-ken, Japan, 470-1192
      • Recruiting
      • Fujita Health University Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 814-0001
      • Recruiting
      • Fukuoka Sanno Hospital
    • Kurume, Fukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital
  • Kyoto
    • Kamigyō-ku, Kyoto, Japan, 602-8566
      • Recruiting
      • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 701-0192
      • Recruiting
      • Kawasaki Medical School Hospital
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Recruiting
      • Nihon University Hospital
    • Minato-Ku, Tokyo, Japan, 107-0052
      • Recruiting
      • Sanno Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years to 75 years
2. Presence of bilateral vocal fold scar or sulcus diagnosed
3. No other vocal lesion or vocal movement disorder
4. Voice Handicap Index-10 (VHI-10) score of 11 or higher
5. 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:

1. No movement disorders of the vocal fold including paralysis
2. Airway disease caused by burn
3. History of malignant tumor
4. History of allergy to local anesthesia agent
5. With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs
6. Serious concomitant disease
7. Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: KP-100LI; Intracordal injection, 20 mcg once per week, 3 weeks	Drug: KP-100LI; Intracordal injection, 20 mcg once per week, 3 weeks; Other Names: Hepatocyte Growth Factor; HGF
Placebo Comparator: Placebo; Intracordal injection, once per week, 3 weeks	Drug: Placebo; Intracordal injection, once per week, 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kringle Pharma, Inc.
• Investigators: Study Director: Daichika Hayata, Kringle Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HGF; Hepatocyte Growth Factor; KP-100LI; KP-100; intracordal injection
• Additional Relevant MeSH Terms: Deafness, Autosomal Recessive 39; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Intercellular Signaling Peptides and Proteins; Cytokines; Hepatocyte Growth Factor
• Other Study ID Numbers: KP-100-FD001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No