Lumbar Disc Herniation
Conditions
Brief summary
The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.
Detailed description
This study was a first-in-human, open-label, non-controlled single ascending dose study of KTP-001 in male and female subjects between the ages of 30 and 70 years with a single herniated lumbar disc. After obtaining informed consent, subjects were evaluated during a screening period of no more than 3 weeks (21 days). This study was conducted in 10 centers in the US. Subjects that met all screening requirements and inclusion criteria and none of the exclusion criteria were enrolled into the study. Overall, 24 subjects were enrolled and treated: 6 subjects in each cohort. Cohort 1 received a 5 μg/disc dose of KTP-001 by intradiscal injection. Following administration of study drug, subjects were confined to the study center for 24 hours to collect data for safety and efficacy measures and collect blood samples for safety, PK evaluation, exploratory PD and anti-KTP-001 antibody and then returned for further assessments at various intervals from weeks 1 through to month 24. After all subjects in Cohort 1 had received study drug, safety measures were evaluated by a Data and Safety Monitoring Board (DSMB) to determine whether to escalate KTP-001 administration to the next dose level. If appropriate, Cohort 2 subjects received 15 μg/disc of KTP-001, Cohort 3 subjects received 50 μg/disc of KTP-001, and Cohort 4 subjects received 150 μg/disc of KTP-001 by intradiscal injection. All safety, PK, and exploratory efficacy assessments were performed for the subjects in the subsequent cohorts as were performed for Cohort 1.
Interventions
DRUGKTP-001
KTP-001 is one time dose intradiscally.
Sponsors
Teijin America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject has had a single contained or noncontained (extruded) lumbar disc herniation (L3-L4, L4-L5 or L5-S1) diagnosed by clinical symptoms and/or physical findings and confirmed by MRI. * Subject has leg pain with a documented positive straight leg raise (SLR) test or femoral stretch test (FST). * Subject has experiences herniated disc symptoms for at least 6 weeks prior to the study without relief with pain medications and other therapies. * Subject has a BMI of 18 to 35 kg/m2
Exclusion criteria
* Subject has a sequestered lumbar disc herniation or intrathecal herniation confirmed by MRI * Subject has two or more symptomatic lumbar disc herniations * Previous intradiscal therapeutic intervention or has had any lumbar surgery * Presence of lumbar spine disease and/or deformity other than a lumbar disc herniation * Active smoker or is unable to abstain from tobacco use for 2 weeks prior to study injection * Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | 24 months | Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results. AEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment. |
| Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | 13 weeks | Assessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | 13 weeks | The serum concentrations of KTP-001 were below the limit of quantification (BLQ) (\<100 ng/mL) at all time points in all participants |
| Number of Participants With Anti-KTP-001 Antibody | 13 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGI-C) | Baseline, 6 weeks and 13 weeks post-dose | The Patient Global Impression Change PGI-C scale was used where the scale ranges are from 1 (no change or condition has got worse) to 7 (a great deal better, and a considerable improvement). The endpoint was the value at 6 and 13 weeks post-dose. |
| Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Baseline, 6 weeks and 13 weeks post-dose | Lower back and leg pain were assessed using an 11-point numerical rating scale (0 = no pain and 10 = worst possible pain). The endpoint was mean change from baseline at 6 and 13 weeks post-dose; with a negative number suggesting an improvement in pain while a positive number suggests a worsening in pain. |
| Changes in Serum Concentrations of Keratan Sulfate | Baseline, 6 and 24 hours and 1, 2, 4, 6 weeks and 13 weeks post-dose | The endpoint was change from baseline at 6 and 24 hours post-dose, and at the 1-, 2-, 4-, 6-, and 13-week follow-up visits or early termination visit. |
| Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Baseline, 6 weeks and 13 weeks post-dose | The changes to spinal flexion and tension were assessed using Straight-Leg Rising (SLR) and Femoral Stretch (FS) tests which are on a scale of no change, positive to negative or negative to positive and where a positive result for SLR may indicate between 30 and 70 degrees, where a positive result for FS may indicate pain in the anterior thigh of the test leg and the elicited pain. |
| Number of Participants With Changes in the Oswestry Disability Index | Baseline, 6 weeks and 13 weeks post-dose | The Oswestry Disability Index (ODI) score is calculated as participant score divided by possible score multiplied by 100, where the following scores can be interpreted to indicate: 0-20% = Minimal disability; 20-40% = Moderate disability; 40-60% = Severe disability; 60-80% = Crippled; 80-100% = Bed bound; |
| Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Baseline, 6 weeks and 13 weeks post-dose | The endpoint was change from baseline at Week 6 and 13 hours post-dose. The Short Form-12 (SF-12) is a Quality of Life questionnaire which measures functional health and well-being from a participant's perspective across eight health domains. Each participant answers questions on a 5-point Likert scale, which rates responses according to how much the participant agrees or disagrees with a particular statement on their health and wellbeing, including vitality/physical functioning/bodily pain/general health perceptions/physical role functioning/emotional role functioning/social role functioning and mental health. Each scale is transformed into a 0-100 scale, assuming each question carries equal weight. Lower scores mean greater disability and higher scores mean less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 KTP-001 5 μg/Disc KTP-001: KTP-001 is one time dose intradiscally. | 6 |
| Cohort 2 KTP-001 15 μg/Disc KTP-001: KTP-001 is one time dose intradiscally. | 6 |
| Cohort 3 KTP-001 50 μg/Disc KTP-001: KTP-001 is one time dose intradiscally. | 6 |
| Cohort 4 KTP-001 150 μg/Disc KTP-001: KTP-001 is one time dose intradiscally. | 6 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Intradiscal Steroid Injection | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 1 |
| Overall Study | Lumbar Surgery | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Cohort 1 KTP-001 5 μg/Disc | Cohort 2 KTP-001 15 μg/Disc | Cohort 3 KTP-001 50 μg/Disc | Cohort 4 KTP-001 150 μg/Disc | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 3.33 | 49.0 years STANDARD_DEVIATION 8.9 | 52.2 years STANDARD_DEVIATION 13.23 | 47.0 years STANDARD_DEVIATION 9.49 | 46.1 years STANDARD_DEVIATION 10.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 6 Participants | 4 Participants | 21 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 14 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 6 / 6 | 5 / 6 |
| serious Total, serious adverse events | 1 / 6 | 2 / 6 | 1 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)
Assessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks.
Time frame: 13 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal changes in ECG | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal changes in ECG | 6 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal CLT | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal CL | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal changes in ECG | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal CLT | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal CL | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal changes in ECG | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal CLT | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal changes in ECG | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal CL | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal changes in ECG | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal CL | 6 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants without abnormal changes in ECG | 6 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal changes in ECG | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT) | Participants with abnormal CLT | 0 Participants |
Primary
Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs
Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results. AEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment.
Time frame: 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AESIs | 4 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any TEAEs | 6 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | TEAEs leading to study discontinuation | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any serious TEAEs | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AEs | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any serious TEAEs | 2 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AESIs | 4 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | TEAEs leading to study discontinuation | 1 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any TEAEs | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AEs | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any serious TEAEs | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AEs | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any TEAEs | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AESIs | 3 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | TEAEs leading to study discontinuation | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AESIs | 2 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any TEAEs | 5 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any AEs | 5 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | Participants with any serious TEAEs | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs | TEAEs leading to study discontinuation | 0 Participants |
Secondary
Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ)
The serum concentrations of KTP-001 were below the limit of quantification (BLQ) (\<100 ng/mL) at all time points in all participants
Time frame: 13 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | BLQ during the study up to 13 weeks | 6 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | Not BLQ during the study up to 13 weeks | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | Not BLQ during the study up to 13 weeks | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | BLQ during the study up to 13 weeks | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | BLQ during the study up to 13 weeks | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | Not BLQ during the study up to 13 weeks | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | BLQ during the study up to 13 weeks | 6 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ) | Not BLQ during the study up to 13 weeks | 0 Participants |
Secondary
Number of Participants With Anti-KTP-001 Antibody
Time frame: 13 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Negative during the study up to 13 weeks | 6 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Positive during the study up to 13 weeks | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Positive during the study up to 13 weeks | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Negative during the study up to 13 weeks | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Negative during the study up to 13 weeks | 6 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Positive during the study up to 13 weeks | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Negative during the study up to 13 weeks | 6 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Anti-KTP-001 Antibody | Positive during the study up to 13 weeks | 0 Participants |
Other Pre-specified
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Lower back and leg pain were assessed using an 11-point numerical rating scale (0 = no pain and 10 = worst possible pain). The endpoint was mean change from baseline at 6 and 13 weeks post-dose; with a negative number suggesting an improvement in pain while a positive number suggests a worsening in pain.
Time frame: Baseline, 6 weeks and 13 weeks post-dose
Population: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week13 | -2.63 score on a scale | Standard Deviation 3.053 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week13 | -2.30 score on a scale | Standard Deviation 3.074 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 13 | -3.4 score on a scale | Standard Deviation 3.05 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 6 | -3.6 score on a scale | Standard Deviation 2.97 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week 6 | -2.66 score on a scale | Standard Deviation 3.669 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 6 | -3.64 score on a scale | Standard Deviation 3.587 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 13 | -3.27 score on a scale | Standard Deviation 2.919 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 13 | -2.4 score on a scale | Standard Deviation 2.61 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week 6 | -2.34 score on a scale | Standard Deviation 3.449 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 6 | -3.72 score on a scale | Standard Deviation 3.984 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 13 | -2.90 score on a scale | Standard Deviation 2.928 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 6 | -2.8 score on a scale | Standard Deviation 3.42 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 13 | -3.7 score on a scale | Standard Deviation 3.01 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 6 | -4.2 score on a scale | Standard Deviation 1.83 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 13 | -4.36 score on a scale | Standard Deviation 2.787 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week 6 | -4.83 score on a scale | Standard Deviation 1.515 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week13 | -5.28 score on a scale | Standard Deviation 1.145 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 13 | -5.2 score on a scale | Standard Deviation 1.83 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 6 | -4.0 score on a scale | Standard Deviation 2.28 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 13 | -4.96 score on a scale | Standard Deviation 3.303 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 6 | -4.27 score on a scale | Standard Deviation 3.066 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 6 | -3.97 score on a scale | Standard Deviation 2.448 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week13 | -5.60 score on a scale | Standard Deviation 2.159 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week 6 | -4.93 score on a scale | Standard Deviation 2.355 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 13 | -3.8 score on a scale | Standard Deviation 3.87 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 6 | -3.2 score on a scale | Standard Deviation 3.9 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 13 | -2.3 score on a scale | Standard Deviation 4.18 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 6 | -3.36 score on a scale | Standard Deviation 2.674 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 13 | -2.17 score on a scale | Standard Deviation 3.572 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 6 | -3.64 score on a scale | Standard Deviation 3.018 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 13 | -2.43 score on a scale | Standard Deviation 3.829 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 6 | -4.2 score on a scale | Standard Deviation 3.96 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week 6 | -3.76 score on a scale | Standard Deviation 2.985 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week13 | -4.20 score on a scale | Standard Deviation 2.647 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week 6 | -4.12 score on a scale | Standard Deviation 3.239 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week13 | -4.23 score on a scale | Standard Deviation 2.986 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 13 | -2.90 score on a scale | Standard Deviation 1.089 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Worst Daily Pain at Week 6 | -3.88 score on a scale | Standard Deviation 2.488 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 6 | -3.8 score on a scale | Standard Deviation 1.79 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week13 | -5.70 score on a scale | Standard Deviation 1.669 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 13 | -4.30 score on a scale | Standard Deviation 1.669 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Low Back Average Daily Pain at Week 6 | -3.84 score on a scale | Standard Deviation 2.551 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week13 | -5.40 score on a scale | Standard Deviation 1.275 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Worst Daily Pain at Week 6 | -3.72 score on a scale | Standard Deviation 3.294 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 13 | -4.4 score on a scale | Standard Deviation 3.13 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Leg Pain at Week 6 | -4.4 score on a scale | Standard Deviation 2.7 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Current Low Back Pain at Week 13 | -2.8 score on a scale | Standard Deviation 2.28 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale | Change in Leg Average Daily Pain at Week 6 | -4.00 score on a scale | Standard Deviation 3.476 |
Other Pre-specified
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
The endpoint was change from baseline at Week 6 and 13 hours post-dose. The Short Form-12 (SF-12) is a Quality of Life questionnaire which measures functional health and well-being from a participant's perspective across eight health domains. Each participant answers questions on a 5-point Likert scale, which rates responses according to how much the participant agrees or disagrees with a particular statement on their health and wellbeing, including vitality/physical functioning/bodily pain/general health perceptions/physical role functioning/emotional role functioning/social role functioning and mental health. Each scale is transformed into a 0-100 scale, assuming each question carries equal weight. Lower scores mean greater disability and higher scores mean less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 6 weeks and 13 weeks post-dose
Population: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 13 | -0.167 score on a scale | Standard Deviation 0.3764 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 6 | 0.000 score on a scale | Standard Deviation 0 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 6 | -0.100 score on a scale | Standard Deviation 0.3791 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 13 | 0.125 score on a scale | Standard Deviation 0.2092 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 13 | 0.000 score on a scale | Standard Deviation 0 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 13 | 0.208 score on a scale | Standard Deviation 0.2458 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 6 | 0.1000 score on a scale | Standard Deviation 0.34686 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 13 | 0.000 score on a scale | Standard Deviation 0.3162 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 6 | 0.2500 score on a scale | Standard Deviation 0.35355 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 6 | 0.400 score on a scale | Standard Deviation 0.4183 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 13 | 0.1875 score on a scale | Standard Deviation 0.27099 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 13 | -0.0417 score on a scale | Standard Deviation 0.06455 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 6 | -0.100 score on a scale | Standard Deviation 0.2236 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 13 | 0.1667 score on a scale | Standard Deviation 0.23274 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 6 | 0.0000 score on a scale | Standard Deviation 0.08839 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 6 | 0.100 score on a scale | Standard Deviation 0.285 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 6 | 0.0625 score on a scale | Standard Deviation 0.06847 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 6 | 0.2292 score on a scale | Standard Deviation 0.27858 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 13 | 0.1667 score on a scale | Standard Deviation 0.2189 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 6 | 0.333 score on a scale | Standard Deviation 0.3028 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 13 | 0.500 score on a scale | Standard Deviation 0.3162 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 13 | -0.125 score on a scale | Standard Deviation 0.1369 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 13 | -0.042 score on a scale | Standard Deviation 0.1021 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 6 | -0.417 score on a scale | Standard Deviation 0.2041 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 6 | 0.292 score on a scale | Standard Deviation 0.2923 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 13 | 0.333 score on a scale | Standard Deviation 0.3028 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 6 | 0.042 score on a scale | Standard Deviation 0.1021 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 6 | 0.2292 score on a scale | Standard Deviation 0.25516 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 13 | -0.417 score on a scale | Standard Deviation 0.2041 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 13 | 0.2083 score on a scale | Standard Deviation 0.32275 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 13 | 0.3542 score on a scale | Standard Deviation 0.30017 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 6 | -0.167 score on a scale | Standard Deviation 0.1291 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 6 | -0.300 score on a scale | Standard Deviation 0.2739 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 13 | -0.167 score on a scale | Standard Deviation 0.1291 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 6 | 0.050 score on a scale | Standard Deviation 0.2092 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 13 | -0.042 score on a scale | Standard Deviation 0.2923 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 6 | 0.250 score on a scale | Standard Deviation 0.25 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 13 | 0.333 score on a scale | Standard Deviation 0.3764 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 6 | 0.2500 score on a scale | Standard Deviation 0.19764 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 13 | 0.2083 score on a scale | Standard Deviation 0.20412 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 6 | 0.0250 score on a scale | Standard Deviation 0.13693 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 13 | 0.0208 score on a scale | Standard Deviation 0.14613 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 6 | 0.400 score on a scale | Standard Deviation 0.4183 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 13 | 0.333 score on a scale | Standard Deviation 0.5401 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 6 | 0.3000 score on a scale | Standard Deviation 0.20917 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 13 | 0.3333 score on a scale | Standard Deviation 0.41583 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 13 | -0.333 score on a scale | Standard Deviation 0.3028 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 6 | -0.100 score on a scale | Standard Deviation 0.1369 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 13 | -0.400 score on a scale | Standard Deviation 0.285 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 6 | 0.2250 score on a scale | Standard Deviation 0.31125 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 13 | 0.2750 score on a scale | Standard Deviation 0.32355 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Emotional score at Week 6 | 0.1750 score on a scale | Standard Deviation 0.31375 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 13 | 0.400 score on a scale | Standard Deviation 0.285 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Role Physical score at Week 13 | 0.3750 score on a scale | Standard Deviation 0.15309 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Social Functioning score at Week 6 | 0.300 score on a scale | Standard Deviation 0.2092 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 13 | -0.200 score on a scale | Standard Deviation 0.2739 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Bodily Pain score at Week 6 | -0.350 score on a scale | Standard Deviation 0.1369 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Vitality score at Week 6 | -0.250 score on a scale | Standard Deviation 0.25 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 13 | -0.100 score on a scale | Standard Deviation 0.1369 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 6 | 0.200 score on a scale | Standard Deviation 0.2092 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in General Health score at Week 6 | -0.150 score on a scale | Standard Deviation 0.1369 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Physical Functioning score at Week 13 | 0.250 score on a scale | Standard Deviation 0.25 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 13 | 0.0250 score on a scale | Standard Deviation 0.16298 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Quality of Life as Assessed by Short Form-12 (SF-12) | Change in Mental Health score at Week 6 | -0.0500 score on a scale | Standard Deviation 0.22707 |
Other Pre-specified
Changes in Serum Concentrations of Keratan Sulfate
The endpoint was change from baseline at 6 and 24 hours post-dose, and at the 1-, 2-, 4-, 6-, and 13-week follow-up visits or early termination visit.
Time frame: Baseline, 6 and 24 hours and 1, 2, 4, 6 weeks and 13 weeks post-dose
Population: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 6 hours | -93.7 ng/ml | Standard Deviation 59.22 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 6 | 1.4 ng/ml | Standard Deviation 74.31 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 4 | -6.2 ng/ml | Standard Deviation 45.44 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 24 hours | -39.2 ng/ml | Standard Deviation 87.9 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 13 | -7.5 ng/ml | Standard Deviation 127.3 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 1 | 77.3 ng/ml | Standard Deviation 30.66 |
| Cohort 1 KTP-001 5 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 2 | 47.0 ng/ml | Standard Deviation 62.77 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 6 | -41.7 ng/ml | Standard Deviation 69.84 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 2 | 22.2 ng/ml | Standard Deviation 81.96 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 1 | 47.2 ng/ml | Standard Deviation 47.31 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 4 | -36.7 ng/ml | Standard Deviation 66.22 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 13 | -39.2 ng/ml | Standard Deviation 63.9 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 24 hours | -73.2 ng/ml | Standard Deviation 34.59 |
| Cohort 2 KTP-001 15 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 6 hours | -84.7 ng/ml | Standard Deviation 47.24 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 2 | 102.0 ng/ml | Standard Deviation 69.13 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 6 hours | -37.3 ng/ml | Standard Deviation 42.28 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 24 hours | 35.2 ng/ml | Standard Deviation 72.37 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 1 | 117.7 ng/ml | Standard Deviation 41.31 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 4 | 87.2 ng/ml | Standard Deviation 49.6 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 6 | 64.0 ng/ml | Standard Deviation 61.46 |
| Cohort 3 KTP-001 50 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 13 | 55.8 ng/ml | Standard Deviation 83.71 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 1 | 297.3 ng/ml | Standard Deviation 144.99 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 13 | -13.6 ng/ml | Standard Deviation 43.64 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 6 | 11.0 ng/ml | Standard Deviation 81.86 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 24 hours | 141.8 ng/ml | Standard Deviation 262.07 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | 6 hours | -24.8 ng/ml | Standard Deviation 49.68 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 4 | 26.8 ng/ml | Standard Deviation 79.08 |
| Cohort 4 KTP-001 150 μg/Disc | Changes in Serum Concentrations of Keratan Sulfate | Week 2 | 173.2 ng/ml | Standard Deviation 120.44 |
Other Pre-specified
Number of Participants With Changes in the Oswestry Disability Index
The Oswestry Disability Index (ODI) score is calculated as participant score divided by possible score multiplied by 100, where the following scores can be interpreted to indicate: 0-20% = Minimal disability; 20-40% = Moderate disability; 40-60% = Severe disability; 60-80% = Crippled; 80-100% = Bed bound;
Time frame: Baseline, 6 weeks and 13 weeks post-dose
Population: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 60-80 Crippled | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 40-60 Severe Disability | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 0-20 Minimal Disability | 2 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | missing | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 80-100 Bedbound | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 20-40 Moderate Disability | 2 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 40-60 Severe Disability | 2 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | missing | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 0-20 Minimal Disability | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 80-100 Bedbound | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 0-20 Minimal Disability | 2 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | missing | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 20-40 Moderate Disability | 3 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 60-80 Crippled | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 80-100 Bedbound | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 60-80 Crippled | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 40-60 Severe Disability | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 20-40 Moderate Disability | 2 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 0-20 Minimal Disability | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 40-60 Severe Disability | 3 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 40-60 Severe Disability | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 20-40 Moderate Disability | 2 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 60-80 Crippled | 1 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 80-100 Bedbound | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | missing | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 0-20 Minimal Disability | 1 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 20-40 Moderate Disability | 5 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 60-80 Crippled | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 80-100 Bedbound | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | missing | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 0-20 Minimal Disability | 3 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 20-40 Moderate Disability | 3 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 40-60 Severe Disability | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 60-80 Crippled | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 80-100 Bedbound | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | missing | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 60-80 Crippled | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 80-100 Bedbound | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 20-40 Moderate Disability | 2 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 80-100 Bedbound | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 40-60 Severe Disability | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 40-60 Severe Disability | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 80-100 Bedbound | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 60-80 Crippled | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 40-60 Severe Disability | 4 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | missing | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | missing | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 0-20 Minimal Disability | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 60-80 Crippled | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | missing | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 0-20 Minimal Disability | 2 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 0-20 Minimal Disability | 3 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 20-40 Moderate Disability | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 20-40 Moderate Disability | 3 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | missing | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 20-40 Moderate Disability | 2 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 40-60 Severe Disability | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 20-40 Moderate Disability | 3 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 60-80 Crippled | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 60-80 Crippled | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 80-100 Bedbound | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 0-20 Minimal Disability | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 0-20 Minimal Disability | 4 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 80-100 Bedbound | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 20-40 Moderate Disability | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 80-100 Bedbound | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 60-80 Crippled | 2 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 13 | 40-60 Severe Disability | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | missing | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | missing | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Week 6 | 0-20 Minimal Disability | 3 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes in the Oswestry Disability Index | Baseline | 40-60 Severe Disability | 1 Participants |
Other Pre-specified
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
The changes to spinal flexion and tension were assessed using Straight-Leg Rising (SLR) and Femoral Stretch (FS) tests which are on a scale of no change, positive to negative or negative to positive and where a positive result for SLR may indicate between 30 and 70 degrees, where a positive result for FS may indicate pain in the anterior thigh of the test leg and the elicited pain.
Time frame: Baseline, 6 weeks and 13 weeks post-dose
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Missing | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Missing | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | No change | 5 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Positive to Negative | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Positive to Negative | 3 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | No change | 2 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Missing | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | No change | 5 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | No change | 2 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Positive to Negative | 4 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Positive to Negative | 1 Participants |
| Cohort 1 KTP-001 5 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Missing | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Positive to Negative | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | No change | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Missing | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Positive to Negative | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | No change | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Missing | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Positive to Negative | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Missing | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | No change | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Missing | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Positive to Negative | 6 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 2 KTP-001 15 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | No change | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Missing | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Missing | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Positive to Negative | 2 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | No change | 2 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | No change | 4 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Missing | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Missing | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | No change | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Positive to Negative | 4 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Positive to Negative | 1 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Positive to Negative | 4 Participants |
| Cohort 3 KTP-001 50 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | No change | 4 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Positive to Negative | 4 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | No change | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Missing | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | No change | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Missing | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Positive to Negative | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Positive to Negative | 4 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Negative to Positive | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Missing | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 13 | Negative to Positive | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Straight-Leg Raising Test at Week 6 | Missing | 1 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | Positive to Negative | 0 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 13 | No change | 5 Participants |
| Cohort 4 KTP-001 150 μg/Disc | Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test | Femoral Stretch Test at Week 6 | No change | 5 Participants |
Other Pre-specified
Patient Global Impression of Change (PGI-C)
The Patient Global Impression Change PGI-C scale was used where the scale ranges are from 1 (no change or condition has got worse) to 7 (a great deal better, and a considerable improvement). The endpoint was the value at 6 and 13 weeks post-dose.
Time frame: Baseline, 6 weeks and 13 weeks post-dose
Population: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 KTP-001 5 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 6 | 4.4 score on a scale | Standard Deviation 3.78 |
| Cohort 1 KTP-001 5 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 13 | 4.7 score on a scale | Standard Deviation 2.34 |
| Cohort 2 KTP-001 15 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 13 | 2.2 score on a scale | Standard Deviation 1.17 |
| Cohort 2 KTP-001 15 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 6 | 2.3 score on a scale | Standard Deviation 1.37 |
| Cohort 3 KTP-001 50 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 6 | 3.2 score on a scale | Standard Deviation 3.27 |
| Cohort 3 KTP-001 50 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 13 | 3.3 score on a scale | Standard Deviation 3.27 |
| Cohort 4 KTP-001 150 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 6 | 2.2 score on a scale | Standard Deviation 1.64 |
| Cohort 4 KTP-001 150 μg/Disc | Patient Global Impression of Change (PGI-C) | Week 13 | 2.8 score on a scale | Standard Deviation 2.39 |