Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

NCT07722962 | Not Yet Recruiting Phase 3

• 1 other identifier: KP-100-ND005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg/body by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.

Conditions

Acute Spinal Cord Injury (SCI)

Keywords

KP-100IT; Hepatocyte growth factor; Intrathecal administration

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration, 24 weeks

  24 weeks after investigational product administration

Secondary Outcomes (8)

• Time course of ASIA motor score (total/ upper extremity / lower upper extremity)

  From baseline through 24 weeks

• Time course of ASIA sensory score

  From baseline through 24 weeks

• Time course of AIS classification

  From baseline through 24 weeks

• Time course of modified Frankel classification

  From baseline through 24 weeks

• Time course of neurological level of injury

  From baseline through 24 weeks

Study Arms (1)

KP-100IT

EXPERIMENTAL

Drug: KP-100IT

Interventions

KP-100IT DRUG

The contents of each vial were dissolved in the distilled water for injection, and the study drug (0.6 mg as KP-100) was administered intrathecally once per week a total of 5 times.

KP-100IT

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whose AIS grade is A at 72 hours (± 6 hours) after injury
• age: 18 years to 89 years
• MRI imaging and other tests confirm the continuity of the spinal cord

You may not qualify if:

• The injury site is C1-C2 or C2-C3
• The patient with a spinal crd compression rate of 70% or higher.
• The patient in whom a spinal cord rupture is strongle suspected.
• The patient cannot start rehabilitation necessary for recovery of function at an early stage.
• External trauma or concurrent organ injury.
• High dose steroid therapy administered for the treatment of spinal cord injury
• History or concurrent presence of malignant tumor.
• It is inappropriate for the subject to be included in the study, in the opinion of the investigator.

Sponsors & Collaborators

• Kringle Pharma, Inc.: lead

Study Sites (3)

Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center

Iizuka, Fukuoka, 820-8508, Japan

Location

Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center

Bibai, Hokkaido, 072-0015, Japan

Location

National Hospital Organization Murayama Medical Center

Musashimurayama, Tokyo, 208-0011, Japan

Location

MeSH Terms

Conditions

Deafness, Autosomal Recessive 39

Central Study Contacts

Daichika Hayata

CONTACT

'+81-6-7653-6728; hayata@kringle-pharma.com

Yurika Abe

CONTACT

+81-6-7653-6728; y.abe@kringle-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

JP (3)