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

Vocal Fold Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627648
• Other study ID #: KP-100-FD001
• Status: Recruiting
• Phase: Phase 3
• Start date: November 24, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Kringle Pharma, Inc.
• Contact: Etsuro Hashimura
• Phone: +81-72-641-8739
• Email: hashimura[@]kringle-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: November 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Vocal Fold Scar

Intervention

Drug:
• KP-100LI
Intracordal injection, 20 mcg once per week, 3 weeks
• Placebo
Intracordal injection, once per week, 3 weeks

Locations

Country	Name	City	State
Japan	Nihon University Hospital	Chiyoda-ku	Tokyo
Japan	University Hospital Kyoto Prefectural University of Medicine	Kamigyo-ku	Kyoto
Japan	Kawasaki Medical School Hospital	Kurashiki	Okayama
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Tohoku University Hospital	Sendai	Miyagi

Sponsors (1)

Lead Sponsor	Collaborator
Kringle Pharma, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period		24 weeks
Secondary	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
Secondary	Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period		up to 24 weeks
Secondary	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
Secondary	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
Secondary	Evaluation of adverse events		up to 24 weeks