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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05627648

Enrollment

Registered

2022-11-25

Start date

2022-12-01

Completion date

2027-02-28

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vocal Fold Scar

Keywords

Hepatocyte Growth Factor, HGF, KP-100LI, KP-100, intracordal injection

Brief summary

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).

Interventions

DRUGKP-100LI

Intracordal injection, 20 mcg once per week, 3 weeks

DRUGPlacebo

Intracordal injection, once per week, 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Contacts

STUDY_DIRECTORDaichika Hayata

Kringle Pharma, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026