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

Phase 3

Recruiting

• Conditions: Vocal Fold Scar
• Interventions: Drug: Placebo; Drug: KP-100LI

• Registration Number: NCT05627648
• Lead Sponsor: Kringle Pharma, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study Start: 2022-11-24
• Study First Posted: 2022-11-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intracordal injection, once per week, 3 weeks
KP-100LI	KP-100LI	Intracordal injection, 20 mcg once per week, 3 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
Evaluation of adverse events	up to 24 weeks
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

Trial Locations

Locations (5)

Kawasaki Medical School Hospital; 🇯🇵 Kurashiki, Okayama, Japan

Tohoku University Hospital; 🇯🇵 Sendai, Miyagi, Japan

Nihon University Hospital; 🇯🇵 Chiyoda-ku, Tokyo, Japan

University Hospital Kyoto Prefectural University of Medicine; 🇯🇵 Kamigyo-ku, Kyoto, Japan

Kurume University Hospital; 🇯🇵 Kurume, Fukuoka, Japan