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

JRCT ID: jRCT2051220132

Registered date:14/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: vocal fold scar, sulcus diagnosed
• Date of first enrollment: 16/01/2023
• Target sample size: 62
• Study type: Interventional

Intervention(s)

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 and larynx

Outcome(s)

• Primary Outcome: Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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 Information

• Primary Sponsor: Sugiyama Yoichiro