Acute Spinal Cord Injury (SCI)Phase 3NCT07722962
Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
A Phase 3 study testing KP-100IT in people with Acute Spinal Cord Injury (SCI), run by Kringle Pharma, Inc. at 3 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Spinal Cord Injury (SCI)
- What is being tested?
- KP-100IT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesJapan
- Study dates
- 31 Jul 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites
Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center
Bibai, Hokkaido, 072-0015
Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center
Iizuka, Fukuoka, 820-8508
+81-948-24-7500
National Hospital Organization Murayama Medical Center
Musashimurayama, Tokyo, 208-0011
About this study
Official title: An Additional Phase 3, Multicenter Study of Intrathecal Administration 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.
- Conditions
- Acute Spinal Cord Injury (SCI)
- Being tested
- KP-100IT
- Keywords
- KP-100IT, Hepatocyte growth factor, Intrathecal administration
- Medical subject headings
- Deafness, Autosomal Recessive 39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-100ITDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| KP-100IT | Experimental | Not described Receives: Drug: KP-100IT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks after investigational product administration
Secondary outcomes (8)
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
Measured: From baseline through 24 weeks
Time course of ASIA sensory score
Measured: From baseline through 24 weeks
Time course of AIS classification
Measured: From baseline through 24 weeks
Time course of modified Frankel classification
Measured: From baseline through 24 weeks
Time course of neurological level of injury
Measured: From baseline through 24 weeks
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
Measured: 12 weeks and 24 weeks after investigational product administration
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration
Measured: From dosing through 24weeks
Evaluation of adverse events
Measured: From the first drug administration through the end of the observation period (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kringle Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722962
- Sponsor's protocol ID
- KP-100-ND005
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07722962
- Acronym / sponsor ID
- KP-100-ND005
- Conditions
- Acute Spinal Cord Injury (SCI)
- Keywords
- KP-100IT, Hepatocyte growth factor, Intrathecal administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kringle Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KP-100IT | Experimental | Drug: KP-100IT |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KP-100ITThe 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. | Drug | KP-100IT |
Primary outcome
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
8 secondary outcomes
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
Time frame: From baseline through 24 weeks
Time course of ASIA sensory score
Time frame: From baseline through 24 weeks
Time course of AIS classification
Time frame: From baseline through 24 weeks
Time course of modified Frankel classification
Time frame: From baseline through 24 weeks
Time course of neurological level of injury
Time frame: From baseline through 24 weeks
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
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration
Time frame: From dosing through 24weeks
Evaluation of adverse events
Time frame: From the first drug administration through the end of the observation period (24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KP-100IT in people with Acute Spinal Cord Injury (SCI), run by Kringle Pharma, Inc. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daichika Hayata ('+81-6-7653-6728, hayata@kringle-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.