Cellulite, Edematous Fibrosclerotic Panniculopathy
Conditions
Brief summary
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
Interventions
BIOLOGICALCollagenase Clostridium Histolyticum
During 3 treatment visits 12 injections will be given per treatment area
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign and date an informed consent agreement 2. Be a female ≥18 years of age 3. At Screening visit, have at least 2 bilateral quadrants with each quadrant having: 1. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and 2. a Hexsel CSS score no greater than 13 4. At Day 1 visit, have assigned bilateral quadrants with each quadrant having: 1. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and 2. a Hexsel CSS score no greater than 13 5. Be willing to apply sunscreen to the assigned treatment quadrants before each exposure to the sun while participating in the study (i.e., Screening through end of study) 6. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at Screening 7. Have a negative serum pregnancy test at Screening and a negative urine pregnancy test before injection of study drug and be using a stable and effective contraception method (e.g., abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile 8. Be willing and able to cooperate with the requirements of the study 9. Be able to read, complete and understand the patient-reported outcomes rating instruments in English
Exclusion criteria
1. Has any of the following systemic conditions: 1. Coagulation disorder 2. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years 3. History of keloidal scarring or abnormal wound healing 4. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor. 5. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values. 2. Has any of the following local conditions in the area to be treated: 1. History of lower extremity thrombosis or post-thrombosis syndrome 2. Vascular disorder (e.g., varicose veins, telangiectasia) in area to be treated 3. Inflammation or active infection 4. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer 5. Has a tattoo and/or a mole located within 2 cm of the site of injection 3. Requires the following concomitant medications before or during participation in the trial: a. Anticoagulant or antiplatelet medication or has received anticoagulant or antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before injection of study drug 4. Has used any of the following for the treatment of EFP on the legs or buttock within the timelines identified below or intends to use any of the following at any time during the course of the study: 1. Liposuction in the areas of the body selected for treatment during the 12-month period before injection of study drug 2. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock and/or thigh implant treatment, or surgery (including subcision and/or powered subcision) within the assigned treatment quadrants during the 12-month period before injection of study drug 3. Endermologie or similar treatments within the assigned treatment quadrants during the 6 month period before injection of study drug 4. Massage therapy within the assigned treatment quadrants during the 3-month period before injection of study drug 5. Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the assigned treatment quadrants during the 2-week period before injection of study drug 5. Is presently nursing or providing breast milk 6. Intends to become pregnant during the study 7. Intends to initiate an intensive sport or exercise program during the study 8. Intends to initiate a weight reduction program during the study 9. Intends to use tanning spray or tanning booths during the study 10. Has received an investigational drug or treatment within 30 days before injection of study drug 11. Has a known systemic allergy to collagenase or any other excipient of study drug 12. Has received any collagenase treatments at any time prior to treatment 13. Was a subject in a previous cellulite clinical trial of collagenase clostridium histolyticum (CCH) : AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, and/or EN3835-202 14. Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | Day 22, 43, 90, and 180 | Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from 0 (None) to 4 (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | Day 22, 43, 90, and 180 | Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from 0 (None) to 4 (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit. |
| Subject Satisfaction With Cellulite Treatment Assessment at End of Study | Day 180 | At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Anti-AUX-II Antibody Log Titer Levels by Visit | Day 1 to Day 180 | Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample. |
| Overall Anti-AUX-I Serum Antibody by Visit | Day 1 to Day 180 | Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample. |
| Anti-AUX-II Neutralizing Antibodies by Visit | Day 1 to Day 180 | A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the study. Number of Participants Analyzed is determined by observed participants that had a seropositive sample at each visit and the antibody level at Day 71 in Q1 and Q4. |
| Anti-AUX-I Neutralizing Antibodies by Visit | Day 1 to Day 180 | A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the highest and lowest quartiles at Day 90 (Q1 and Q4) of seropositive participants at each of two visits (Day 90 and Day 180). |
| Overall Anti-AUX-I Antibody Log Titer Levels by Visit | Day 1 to Day 180 | Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample. |
| Overall Anti-AUX-II Serum Antibody by Visit | Day 1 to Day 180 | Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Collagenase Clostridium Histolyticum (CCH) 12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits. | 158 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 10.41 |
| Body Mass Index (BMI) | 26.74 kg/m^2 STANDARD_DEVIATION 5.259 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 135 Participants |
| Sex: Female, Male Female | 158 Participants |
| Sex: Female, Male Male | 0 Participants |
| Skin Category (Fitzpatrick Scale) II (Fair) | 34 Participants |
| Skin Category (Fitzpatrick Scale) III (Darker White) | 53 Participants |
| Skin Category (Fitzpatrick Scale) I (Pale White) | 3 Participants |
| Skin Category (Fitzpatrick Scale) IV (Light Brown) | 48 Participants |
| Skin Category (Fitzpatrick Scale) V (Brown) | 10 Participants |
| Skin Category (Fitzpatrick Scale) VI (Dark Brown) | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 158 |
| other Total, other adverse events | 158 / 158 |
| serious Total, serious adverse events | 1 / 158 |
Outcome results
Primary
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from 0 (None) to 4 (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
Time frame: Day 22, 43, 90, and 180
Population: Effectiveness Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 180 | Yes | 20 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 180 | No | 111 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 22 | Yes | 6 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 22 | No | 131 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 43 | Yes | 8 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 43 | No | 125 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 90 | Yes | 17 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | At Least One of two areas (Left & Right): Day 90 | No | 110 Participants |
Secondary
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from 0 (None) to 4 (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit.
Time frame: Day 22, 43, 90, and 180
Population: Effectiveness Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 22 | Yes | 55 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 22 | No | 82 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 43 | Yes | 87 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 43 | No | 46 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 90 | Yes | 96 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 90 | No | 31 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 180 | Yes | 90 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | At Least One of Two Areas (Left & Right): Day 180 | No | 41 Participants |
Secondary
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts.
Time frame: Day 180
Population: Overall number of participants analyzed is the number participants in effectiveness population at Day 180.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Subject Satisfaction With Cellulite Treatment Assessment at End of Study | Very Satisfied with Treatment (2) | 25 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subject Satisfaction With Cellulite Treatment Assessment at End of Study | Satisfied with Treatment (1) | 48 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subject Satisfaction With Cellulite Treatment Assessment at End of Study | Neither Dissatisfied nor Satisfied with Treatment | 32 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subject Satisfaction With Cellulite Treatment Assessment at End of Study | Dissatisfied with Treatment (-1) | 12 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subject Satisfaction With Cellulite Treatment Assessment at End of Study | Very Dissatisfied with Treatment (-2) | 13 Participants |
Other Pre-specified
Anti-AUX-II Neutralizing Antibodies by Visit
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the study. Number of Participants Analyzed is determined by observed participants that had a seropositive sample at each visit and the antibody level at Day 71 in Q1 and Q4.
Time frame: Day 1 to Day 180
Population: Safety Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-II Neutralizing Antibodies by Visit | anti-AUX-II Neutralizing Antibodies: Day 1 | Positive | 1 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-II Neutralizing Antibodies by Visit | anti-AUX-II Neutralizing Antibodies: Day 1 | Negative | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-II Neutralizing Antibodies by Visit | anti-AUX-II Neutralizing Antibodies: Day 90 | Positive | 24 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-II Neutralizing Antibodies by Visit | anti-AUX-II Neutralizing Antibodies: Day 90 | Negative | 8 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-II Neutralizing Antibodies by Visit | anti-AUX-II Neutralizing Antibodies: Day 180 | Positive | 20 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-II Neutralizing Antibodies by Visit | anti-AUX-II Neutralizing Antibodies: Day 180 | Negative | 11 Participants |
Other Pre-specified
Anti-AUX-I Neutralizing Antibodies by Visit
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the highest and lowest quartiles at Day 90 (Q1 and Q4) of seropositive participants at each of two visits (Day 90 and Day 180).
Time frame: Day 1 to Day 180
Population: Safety Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-I Neutralizing Antibodies by Visit | anti-AUX-I Neutralizing Antibody: Day 1 | Positive | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-I Neutralizing Antibodies by Visit | anti-AUX-I Neutralizing Antibody: Day 1 | Negative | 1 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-I Neutralizing Antibodies by Visit | anti-AUX-I Neutralizing Antibody: Day 90 | Positive | 26 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-I Neutralizing Antibodies by Visit | anti-AUX-I Neutralizing Antibody: Day 90 | Negative | 8 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-I Neutralizing Antibodies by Visit | anti-AUX-I Neutralizing Antibody: Day 180 | Positive | 19 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Anti-AUX-I Neutralizing Antibodies by Visit | anti-AUX-I Neutralizing Antibody: Day 180 | Negative | 14 Participants |
Other Pre-specified
Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Antibody Log Titer Levels by Visit | Anti-AUX-I: Day 90 positive | 5.937 log 10 titer | Standard Deviation 0.686 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Antibody Log Titer Levels by Visit | Anti-AUX-I: Day 1 positive | 2.046 log 10 titer | Standard Deviation 1.012 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Antibody Log Titer Levels by Visit | Anti-AUX-I: Day 22 positive | 2.268 log 10 titer | Standard Deviation 1.076 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Antibody Log Titer Levels by Visit | Anti-AUX-I: Day 43 positive | 4.681 log 10 titer | Standard Deviation 0.924 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Antibody Log Titer Levels by Visit | Anti-AUX-I: Day 180 positive | 5.556 log 10 titer | Standard Deviation 0.981 |
Other Pre-specified
Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Antibody Log Titer Levels by Visit | Anti-AUX-II: Day 1 positive | 1.607 log 10 titer | Standard Deviation 0.947 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Antibody Log Titer Levels by Visit | Anti-AUX-II: Day 22 positive | 1.942 log 10 titer | Standard Deviation 1.068 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Antibody Log Titer Levels by Visit | Anti-AUX-II: Day 43 positive | 3.641 log 10 titer | Standard Deviation 1.068 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Antibody Log Titer Levels by Visit | Anti-AUX-II: Day 90 positive | 5.255 log 10 titer | Standard Deviation 0.809 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Antibody Log Titer Levels by Visit | Anti-AUX-II: Day 180 positive | 5.141 log 10 titer | Standard Deviation 0.913 |
Other Pre-specified
Overall Anti-AUX-II Serum Antibody by Visit
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Population: Safety Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 1 | Seropositive | 6 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 1 | Seronegative | 150 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 22 | Seropositive | 50 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 22 | Seronegative | 98 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 43 | Seropositive | 138 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 43 | Seronegative | 5 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 90 | Seropositive | 131 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 90 | Seronegative | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 180 | Seropositive | 130 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-II Serum Antibody by Visit | Anti-AUX-I: Day 180 | Seronegative | 5 Participants |
Other Pre-specified
Overall Anti-AUX-I Serum Antibody by Visit
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Population: Safety Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 1 | Seropositive | 4 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 1 | Seronegative | 152 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 180 | Seronegative | 1 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 22 | Seropositive | 104 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 22 | Seronegative | 43 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 43 | Seropositive | 141 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 43 | Seronegative | 2 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 90 | Seropositive | 134 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 90 | Seronegative | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Overall Anti-AUX-I Serum Antibody by Visit | Anti-AUX-I: Day 180 | Seropositive | 134 Participants |