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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051220132

Enrollment

Registered

2022-12-14

Start date

2023-01-16

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

vocal fold scar, sulcus diagnosed

Interventions

1. Active ingredient

dHGF, Oremepermin Alfa 2. KP-100LI treatment arm

KP-100LI solution 0.2 mL (KP-100LI

20 mcg) , once per week, 4 times repeated dosing 3. Placebo treatment arm

Placebo solution 0.2 mL, once per week, 4 times repeated dosing 4. An intramucosal injection into the vocal cords using a laryngeal needle 5. Surface anesthesia will be administered to the pharynx an

Eligibility

Sex/Gender

All

Inclusion criteria

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

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	—

Secondary

Measure	Time frame
(1) 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 (2) Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period (3) Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period (4) Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observation al period (5) Evaluation of adverse events	—

Measure

Time frame

(1) 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 (2) Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period (3) Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period (4) Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observation al period (5) Evaluation of adverse events

—

Contacts

Public ContactHideo Murakami

Kringle Pharma,Inc.

h.murakami@kringle-pharma.com+81-6-7653-6728

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026