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NCT Number: NCT07722962

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

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.

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Key information

Conditions

Acute Spinal Cord Injury (SCI) Deafness, Autosomal Recessive 39

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

    Time frame: 24 weeks after investigational product administration

Secondary outcomes

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

    Time frame: From baseline through 24 weeks

  2. Time course of ASIA sensory score

    Time frame: From baseline through 24 weeks

  3. Time course of AIS classification

    Time frame: From baseline through 24 weeks

  4. Time course of modified Frankel classification

    Time frame: From baseline through 24 weeks

  5. Time course of neurological level of injury

    Time frame: From baseline through 24 weeks

  6. Percentage of subjects improving by at least 5 and 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration

    Time frame: 12 weeks and 24 weeks after investigational product administration

  7. Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration

    Time frame: From dosing through 24weeks

  8. Evaluation of adverse events

    Time frame: From the first drug administration through the end of the observation period (24 weeks)

Study contacts

Contact information is provided by the study sponsor or research team.

Daichika Hayata

CONTACT

[email protected]

'+81-6-7653-6728

Yurika Abe

CONTACT

[email protected]

+81-6-7653-6728

Sponsors and collaborators

Lead sponsor

Kringle Pharma, Inc.

Industry

Registry information

Official study title

An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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