Diabetes Mellitus, Diabetic Foot Ulcer, Wounds
Conditions
Keywords
Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Standard of Care, wounds
Brief summary
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
Detailed description
This study was designed as a randomized, double-blind, vehicle-controlled, multiple-center, and parallel trial to evaluate the efficacy and safety of CSTC1 in patients with diabetic foot ulcers (DFU). In each study site, eligible patients were randomized in a 4:1 ratio to receive either one of the topical applications of CSTC1 or CSTC1 matched vehicle, topical application on target diabetic foot ulcer (DFU), 2 times daily. The treatment duration for each subject was 12 weeks or up to confirmed complete ulcer closure, whichever comes first. That was, subjects would receive treatment for at most 12 weeks, which consists of 8 visits located at weeks 1, 2, 3, 4, 6, 8, 10, and 12. Subjects who achieved confirmed complete ulcer closure during the treatment period would be arranged for a 12 week post-treatment follow-up. Subjects failed to achieve complete ulcer closure at week-12 visit would be arranged for 4 weeks of safety follow-up. If confirmation of complete ulcer closure was reached at a week-14 visit, the subject would continue the post-treatment follow-up visit until week-24 visit. Otherwise, the subject would be arranged for safety follow-up until week-16 visit.
Interventions
DRUGCSTC1
vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
DRUGCSTC1 Matched vehicle
Sponsors
ASKLEP Inc.
Charsire Biotechnology Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With either gender aged at least 20 years old; * With a diabetic ulcer (which is defined as the target ulcer) on the foot and not healing for at least 2 weeks; * The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner system; * The target ulcer should show infection control at investigator's discretion; * Subject should be free of any necrosis or infection in soft and bone tissue; * Subject has signed the written informed consent form
Exclusion criteria
* With active osteomyelitis; * With target ulcer size decreased by at least 50% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit; * With poor nutritional status (albumin \< 3g/dl), poor diabetic control (HbA1c \> 12%), anemia (hemoglobin\<10 g/dL), a leukocyte counts \< 1,000/mm3, abnormal liver function (AST, ALT\>3 x upper limit of normal range); * Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents; * Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement; * Receiving revascularization surgery performed \<8 weeks before entry in the study; * With known or suspected hypersensitivity to any ingredients of study product and vehicle; * With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study; * Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period; * Enrollment in any investigational drug trial within 4 weeks before entering this study; * With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Ulcer Closure During the Treatment Period | Baseline to 14 weeks | Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at the coming visits 2 weeks apart. The treatment period is until 12 weeks or up to confirmation of complete ulcer closure. Subjects with complete ulcer closure at Week 12 and confirmed at Week 14 were considered as success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ulcer Closure Time | 24 weeks | Defined as the time to complete ulcer closure. |
| The Accumulated Participant Counts With Complete Ulcer Closure | 24 weeks | Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements observed for at the last two consecutive study visits 2 weeks apart. The count of participants with complete ulcer closure at each post-treatment visit is provided. |
| Percentage Change in Ulcer Size for Each Post-treatment Visit | baseline and 24 weeks | The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). This proportion was then multiplied by 100 to calculate the percentage change in ulcer size for each post-treatment visit. The percentage change in ulcer size for each post-treatment visit are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulse Rate Change From Baseline to Week 24 | baseline and 24 weeks | Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, pulse rates were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline). |
| Number of Participants With Adverse Events | 24 weeks | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication, whether or not related to the study medication. AE data was collected from Screening visit to Final visit (up to 24 weeks). |
| Respiratory Rate Change From Baseline to Week 24 | baseline and 24 weeks | Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, respiratory rate were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline). |
| Body Temperature Change From Baseline to Week 24 | baseline and 24 weeks | Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, body temperature were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline). |
| Number of Participants With Physical Abnormality Finding at the Visits | 24 weeks | Physical examinations in this study included the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others. Physical examinations were conducted from Screening visit to Final visit (up to 24 weeks). If at least one of physical examinations was identified in the subject, the subject was included in physical abnormalities calculation. |
| Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | baseline and 12 weeks | Laboratory examination to be measured in this study consisted of hematology (hemoglobin, hematocrit, RBC, platelet, WBC with differential counts) and biochemistry (Aspartate Transaminase (AST), Alanine Transaminase (ALT), fasting glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin). The laboratory examinations were conducted at the Screening visit, baseline, and Week 12. Patients' laboratory change from baseline to Week 12 was documented as relieved, unchanged, worsened (MH), or worsened (AE). The worsened means that the laboratory values were normal or non clinically significant (NCS) at baseline but change to clinically significant at Week 12. If the worsen situation was found, the clinically significant worsening changes were classified as related to medical history (MH) or adverse events (AE). |
| Blood Pressure Change From Baseline to Week 24 | baseline and 24 weeks | Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, blood pressure (systolic/diastolic) were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline). |
Countries
Taiwan
Participant flow
Pre-assignment details
The planned sample size was determined to be 80 versus 20 subjects (4:1 ratio) for treatment versus vehicle groups, 100 subjects in total. To ensure the completion of 100 evaluable subjects, around 125 subjects were planned to be recruited. In the actual trial, a total of 137 subjects were screened, with 124 meeting the criteria followed by randomization to CSTC1 group (n = 98) or Vehicle group (n = 26).
Participants by arm
| Arm | Count |
|---|---|
| CSTC1 CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily | 98 |
| CSTC1 Matched Vehicle Matched vehicle, topical, two times daily | 26 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Prohibited Medication Administration or Condition Worsening | 7 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Safety Concern | 4 | 0 |
| Overall Study | Ulcer became worse | 4 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 5 |
Baseline characteristics
| Characteristic | CSTC1 | CSTC1 Matched Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 13.79 | 58.6 years STANDARD_DEVIATION 11.84 | 58.2 years STANDARD_DEVIATION 13.36 |
| Baseline Diabetic Foot Target Ulcer Size > 10 ~ 15 cm^2 | 4 Participants | 1 Participants | 5 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 1 ~ 1.5 cm^2 | 27 Participants | 5 Participants | 32 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 15 ~ 20 cm^2 | 2 Participants | 1 Participants | 3 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 1.5 ~ 2 cm^2 | 11 Participants | 4 Participants | 15 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 20 cm^2 | 2 Participants | 1 Participants | 3 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 2 ~ 3 cm^2 | 15 Participants | 4 Participants | 19 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 3 ~ 4 cm^2 | 14 Participants | 2 Participants | 16 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 4 ~ 5 cm^2 | 8 Participants | 4 Participants | 12 Participants |
| Baseline Diabetic Foot Target Ulcer Size > 5 ~ 10 cm^2 | 15 Participants | 4 Participants | 19 Participants |
| Baseline Target Ulcer Size | 4.37 cm^2 STANDARD_DEVIATION 5.471 | 5.15 cm^2 STANDARD_DEVIATION 5.531 | 4.53 cm^2 STANDARD_DEVIATION 5.47 |
| Maximum Grade of Foot Ulcers Grade 1 | 15 Participants | 4 Participants | 19 Participants |
| Maximum Grade of Foot Ulcers Grade 2 | 83 Participants | 22 Participants | 105 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Taiwan | 98 Participants | 26 Participants | 124 Participants |
| Sex: Female, Male Female | 67 Participants | 17 Participants | 84 Participants |
| Sex: Female, Male Male | 31 Participants | 9 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 98 | 1 / 26 |
| other Total, other adverse events | 44 / 98 | 13 / 26 |
| serious Total, serious adverse events | 20 / 98 | 3 / 26 |
Outcome results
Primary
Number of Participants With Complete Ulcer Closure During the Treatment Period
Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at the coming visits 2 weeks apart. The treatment period is until 12 weeks or up to confirmation of complete ulcer closure. Subjects with complete ulcer closure at Week 12 and confirmed at Week 14 were considered as success.
Time frame: Baseline to 14 weeks
Population: All randomized subjects who have received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSTC1 | Number of Participants With Complete Ulcer Closure During the Treatment Period | 32 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Complete Ulcer Closure During the Treatment Period | 4 Participants |
Secondary
Percentage Change in Ulcer Size for Each Post-treatment Visit
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). This proportion was then multiplied by 100 to calculate the percentage change in ulcer size for each post-treatment visit. The percentage change in ulcer size for each post-treatment visit are presented.
Time frame: baseline and 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 1 | -15.2 percent change | Standard Deviation 28.31 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 2 | -28.3 percent change | Standard Deviation 30.32 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 3 | -36.3 percent change | Standard Deviation 34.93 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 4 | -46.6 percent change | Standard Deviation 35.15 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 6 | -53.6 percent change | Standard Deviation 40.13 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 8 | -56.7 percent change | Standard Deviation 49.96 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 10 | -61.7 percent change | Standard Deviation 47.01 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 20 | -70.4 percent change | Standard Deviation 38.6 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 12 | -66.3 percent change | Standard Deviation 41.91 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 14 | -69.1 percent change | Standard Deviation 39.09 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 16 | -69.8 percent change | Standard Deviation 38.4 |
| CSTC1 | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 24 | -70.2 percent change | Standard Deviation 38.52 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 20 | -59.1 percent change | Standard Deviation 60.05 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 1 | -16.3 percent change | Standard Deviation 25.09 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 16 | -59.1 percent change | Standard Deviation 60.05 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 2 | -21.7 percent change | Standard Deviation 32.82 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 14 | -57.6 percent change | Standard Deviation 57.54 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 3 | -29.1 percent change | Standard Deviation 41 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 10 | -51.8 percent change | Standard Deviation 44.85 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 4 | -32.8 percent change | Standard Deviation 36.9 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 24 | -59.0 percent change | Standard Deviation 59.95 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 6 | -44.8 percent change | Standard Deviation 41.11 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 12 | -54.2 percent change | Standard Deviation 56.52 |
| CSTC1 Matched Vehicle | Percentage Change in Ulcer Size for Each Post-treatment Visit | Week 8 | -47.0 percent change | Standard Deviation 46.67 |
Secondary
The Accumulated Participant Counts With Complete Ulcer Closure
Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements observed for at the last two consecutive study visits 2 weeks apart. The count of participants with complete ulcer closure at each post-treatment visit is provided.
Time frame: 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 1 | 0 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 2 | 0 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 3 | 0 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 4 | 0 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 6 | 2 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 8 | 9 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 10 | 13 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 12 | 22 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 14 | 32 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 16 | 35 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 20 | 35 Participants |
| CSTC1 | The Accumulated Participant Counts With Complete Ulcer Closure | Week 24 | 36 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 20 | 7 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 1 | 0 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 10 | 1 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 2 | 0 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 16 | 7 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 3 | 0 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 12 | 2 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 4 | 0 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 24 | 6 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 6 | 1 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 14 | 4 Participants |
| CSTC1 Matched Vehicle | The Accumulated Participant Counts With Complete Ulcer Closure | Week 8 | 1 Participants |
Secondary
The Ulcer Closure Time
Defined as the time to complete ulcer closure.
Time frame: 24 weeks
Population: All randomized subjects who have received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSTC1 | The Ulcer Closure Time | 87 Days | Standard Error 2.2 |
| CSTC1 Matched Vehicle | The Ulcer Closure Time | 92 Days | Standard Error 3.2 |
Other Pre-specified
Blood Pressure Change From Baseline to Week 24
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, blood pressure (systolic/diastolic) were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Time frame: baseline and 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSTC1 | Blood Pressure Change From Baseline to Week 24 | Systolic Blood Pressure [mmHg] | -3.67 mmHg | Standard Deviation 27.088 |
| CSTC1 | Blood Pressure Change From Baseline to Week 24 | Diastolic Blood Pressure [mmHg] | 1.41 mmHg | Standard Deviation 13.882 |
| CSTC1 Matched Vehicle | Blood Pressure Change From Baseline to Week 24 | Systolic Blood Pressure [mmHg] | -20.00 mmHg | Standard Deviation 34.137 |
| CSTC1 Matched Vehicle | Blood Pressure Change From Baseline to Week 24 | Diastolic Blood Pressure [mmHg] | -6.25 mmHg | Standard Deviation 4.646 |
Other Pre-specified
Body Temperature Change From Baseline to Week 24
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, body temperature were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Time frame: baseline and 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSTC1 | Body Temperature Change From Baseline to Week 24 | 0.08 degrees Celsius | Standard Deviation 0.468 |
| CSTC1 Matched Vehicle | Body Temperature Change From Baseline to Week 24 | 0.33 degrees Celsius | Standard Deviation 0.377 |
Other Pre-specified
Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication, whether or not related to the study medication. AE data was collected from Screening visit to Final visit (up to 24 weeks).
Time frame: 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSTC1 | Number of Participants With Adverse Events | 80 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Adverse Events | 22 Participants |
Other Pre-specified
Number of Participants With Physical Abnormality Finding at the Visits
Physical examinations in this study included the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others. Physical examinations were conducted from Screening visit to Final visit (up to 24 weeks). If at least one of physical examinations was identified in the subject, the subject was included in physical abnormalities calculation.
Time frame: 24 weeks
Population: All randomized patients who have received at least one dose study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 4 | 57 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 12 | 41 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 1 | 57 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 14 | 43 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 6 | 57 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 16 | 42 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 3 | 59 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 20 | 18 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 8 | 52 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 24 | 15 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 2 | 57 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Baseline (Day 1) | 57 participants |
| CSTC1 | Number of Participants With Physical Abnormality Finding at the Visits | Week 10 | 45 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Baseline (Day 1) | 18 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 2 | 18 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 3 | 16 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 4 | 16 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 6 | 17 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 8 | 16 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 10 | 16 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 12 | 16 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 14 | 12 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 16 | 12 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 20 | 2 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 24 | 2 participants |
| CSTC1 Matched Vehicle | Number of Participants With Physical Abnormality Finding at the Visits | Week 1 | 18 participants |
Other Pre-specified
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Laboratory examination to be measured in this study consisted of hematology (hemoglobin, hematocrit, RBC, platelet, WBC with differential counts) and biochemistry (Aspartate Transaminase (AST), Alanine Transaminase (ALT), fasting glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin). The laboratory examinations were conducted at the Screening visit, baseline, and Week 12. Patients' laboratory change from baseline to Week 12 was documented as relieved, unchanged, worsened (MH), or worsened (AE). The worsened means that the laboratory values were normal or non clinically significant (NCS) at baseline but change to clinically significant at Week 12. If the worsen situation was found, the clinically significant worsening changes were classified as related to medical history (MH) or adverse events (AE).
Time frame: baseline and 12 weeks
Population: All randomized patients who have received at least one dose study medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Relieved | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Unchanged | 81 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Worsened (MH) | 2 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Worsened (AE) | 5 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Relieved | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Unchanged | 84 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Worsened (MH) | 2 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Worsened (AE) | 1 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Relieved | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Unchanged | 87 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Worsened (MH) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Relieved | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Unchanged | 87 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Worsened (MH) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Relieved | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Unchanged | 83 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Worsened (MH) | 2 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Worsened (AE) | 2 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Relieved | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Unchanged | 87 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Worsened (MH) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Relieved | 2 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Unchanged | 81 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Worsened (MH) | 5 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Relieved | 3 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Unchanged | 80 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Worsened (MH) | 5 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Relieved | 2 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Unchanged | 82 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Worsened (MH) | 4 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Relieved | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Unchanged | 86 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Worsened (MH) | 2 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Relieved | 5 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Unchanged | 79 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Worsened (MH) | 4 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Relieved | 1 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Unchanged | 85 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Worsened (MH) | 1 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Relieved | 1 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Unchanged | 86 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Worsened (MH) | 1 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Relieved | 6 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Unchanged | 77 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Worsened (MH) | 5 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Relieved | 6 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Unchanged | 78 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Worsened (MH) | 4 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Worsened (AE) | 0 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Relieved | 13 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Unchanged | 66 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Worsened (MH) | 9 Participants |
| CSTC1 | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Unchanged | 21 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | White blood cells (10^9/L) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Relieved | 1 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Worsened (MH) | 1 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hematocrit (%) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Neutrophils (%) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Relieved | 1 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Eosinophils (%) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Unchanged | 21 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Alanine Aminotransferase (U/L) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Platelets (10^9/L) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Basophils (%) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Worsened (MH) | 3 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Relieved | 2 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Unchanged | 21 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Lymphocytes (%) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Worsened (MH) | 1 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Unchanged | 19 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin A1C (%) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Monocytes (%) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Glucose (mg/dL) | Unchanged | 18 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Unchanged | 21 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Worsened (MH) | 1 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Worsened (MH) | 1 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Unchanged | 22 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Red Blood Cells (^12/L) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Creatinine (umol/L) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Relieved | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Worsened (MH) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Unchanged | 21 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Blood Urea Nitrogen (U/L) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Worsened (MH) | 1 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Aspartate Aminotransferase (U/L) | Worsened (AE) | 0 Participants |
| CSTC1 Matched Vehicle | Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline | Hemoglobin (g/mL) | Worsened (AE) | 0 Participants |
Other Pre-specified
Pulse Rate Change From Baseline to Week 24
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, pulse rates were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Time frame: baseline and 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSTC1 | Pulse Rate Change From Baseline to Week 24 | 4.00 beats/min | Standard Deviation 9.899 |
| CSTC1 Matched Vehicle | Pulse Rate Change From Baseline to Week 24 | -1.25 beats/min | Standard Deviation 9.323 |
Other Pre-specified
Respiratory Rate Change From Baseline to Week 24
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, respiratory rate were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Time frame: baseline and 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSTC1 | Respiratory Rate Change From Baseline to Week 24 | -0.11 breaths/min | Standard Deviation 1.672 |
| CSTC1 Matched Vehicle | Respiratory Rate Change From Baseline to Week 24 | -3.25 breaths/min | Standard Deviation 3.862 |
Post Hoc
The Response Rate of the Target Ulcer Size Reduction ≥ 50%
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). A subject who had target ulcer closure ≥ 50% was counted as a responder. The non-responders included subjects whose target ulcer closure size less than 50% before 12 weeks.
Time frame: 12 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CSTC1 | The Response Rate of the Target Ulcer Size Reduction ≥ 50% | Responder | 77 Participants |
| CSTC1 | The Response Rate of the Target Ulcer Size Reduction ≥ 50% | Non-Responder | 21 Participants |
| CSTC1 Matched Vehicle | The Response Rate of the Target Ulcer Size Reduction ≥ 50% | Responder | 18 Participants |
| CSTC1 Matched Vehicle | The Response Rate of the Target Ulcer Size Reduction ≥ 50% | Non-Responder | 8 Participants |
Post Hoc
The Response Rate of the Target Ulcer Size Reduction ≥ 90%
Subjects with ulcer closure size ≥ 90% compared to the baseline at a Week 12 were considered as a responder. A subject whose target ulcer size reduction was less than 90% was counted as a non-responder. The percentage of repsonders and non-responders were presented.
Time frame: 12 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CSTC1 | The Response Rate of the Target Ulcer Size Reduction ≥ 90% | Responder | 49 Participants |
| CSTC1 | The Response Rate of the Target Ulcer Size Reduction ≥ 90% | Non-Responder | 49 Participants |
| CSTC1 Matched Vehicle | The Response Rate of the Target Ulcer Size Reduction ≥ 90% | Responder | 12 Participants |
| CSTC1 Matched Vehicle | The Response Rate of the Target Ulcer Size Reduction ≥ 90% | Non-Responder | 14 Participants |
Post Hoc
Time to Achieve ≥ 50% Reduction in Target Ulcer Size
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 50% reduction in target ulcer size was measured from Screening visit to Final visit (up to 24 weeks).
Time frame: 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSTC1 | Time to Achieve ≥ 50% Reduction in Target Ulcer Size | 42 Days | Standard Deviation 3.3 |
| CSTC1 Matched Vehicle | Time to Achieve ≥ 50% Reduction in Target Ulcer Size | 52 Days | Standard Deviation 7.1 |
Post Hoc
Time to Achieve ≥90% Reduction in Target Ulcer Size
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 90% reduction in target ulcer size was analyzed in the subjects.
Time frame: 24 weeks
Population: All randomized patients who have received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSTC1 | Time to Achieve ≥90% Reduction in Target Ulcer Size | 73 Days | Standard Deviation 2.9 |
| CSTC1 Matched Vehicle | Time to Achieve ≥90% Reduction in Target Ulcer Size | 84 Days | Standard Deviation 4.4 |