Edematous Fibrosclerotic Panniculopathy (Cellulite)
Conditions
Brief summary
Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.
Interventions
BIOLOGICALEN3835
Collagenase clostridium histolyticum
BIOLOGICALPlacebo
Placebo
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily sign and date an informed consent agreement 2. Be a female ≥18 years of age 3. At Screening visit, have 2 bilateral buttocks with each buttock having: 1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS) 4. At Day 1 visit, have 2 bilateral buttocks with each buttock having: 1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS) 5. Be willing to apply sunscreen to the buttocks before each exposure to the sun while participating in the study (ie, 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 (eg, 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 areas to be treated: 1. History of lower extremity thrombosis or post-thrombosis syndrome 2. Vascular disorder (eg, varicose veins, telangiectasia) in area to be treated 3. Inflammation or active infection 4. Severe skin laxity, flaccidity, and/or sagging 5. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer 6. 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 a 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 a buttock during the 12-month period before injection of study drug 2. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) within a buttock during the 12-month period before injection of study drug 3. Any investigational treatment for EFP on a buttock during the 12-month period before the injection of study drug 4. Endermologie or similar treatments within a buttock during the 6-month period before injection of study drug 5. Massage therapy within a buttock during the 3-month period before injection of study drug 6. Creams (eg, Celluvera™, TriLastin®) and/or home therapies to prevent or mitigate EFP within a buttock 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 CCH: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, and/or EN3835-205 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 |
|---|---|---|
| 2-level Composite Responders for the Target Buttock | Day 71 | Number of of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe). A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder. A 2-level composite responder is defined as a participant with an improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-level SSRS Responders | Day 71 | Subject Self-Rating Scale (SSRS) is a measure that assesses participant satisfaction with appearance in association with cellulite on the buttocks using whole numbers on a 7-level scale that ranges from 0 (Extremely Dissatisfied) to 6 (Extremely Satisfied). A 1-level SSRS responder is defined as a participant who is at least slightly satisfied (Slightly Satisfied \[4\], Very Satisfied \[5\], or Extremely Satisfied \[6\]) with the appearance of the cellulite on her buttocks at Day 71. |
| 1-level S-GAIS Responders of Target Buttock | Day 71 | Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from +3 (Very Much Improved) to -3 (Very Much Worse). Responders are defined as participants with at least ≥ 1-level improvement (Improved, Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock. |
| 2-level S-GAIS Responders of Target Buttock | Day 71 | Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from +3 (Very Much Improved) to -3 (Very Much Worse). Responders are defined as participants with at least ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock. |
| PR-PCSS Rating for the Target and Non-target Buttock by Visit | Day 1 to Day 71 | The Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level photonumeric scale used by the patient (participant) to assess the severity of the participant's cellulite. The scale ratings range from 0 (None) to 4 (Severe). |
| 1-level PR-PCSS Responders of the Target Buttock | Day 71 | Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe). |
| 2-level PR-PCSS Responders of the Target Buttock | Day 71 | Improvement in cellulite severity of the Target Buttock from baseline of at least 2-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe). |
| 1-level Composite Responders of the Target Buttock | Day 71 | Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe). |
| 2-level Composite Responder of the Non-target Buttock | Day 71 | Improvement in cellulite severity of the Non-target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe). |
| Subjects Satisfaction With Cellulite Treatment at Day 71 | Day 71 | A 1-level Subject Satisfaction responder is defined as a participant who is at least Satisfied (Satisfied \[+1\], or Very Satisfied \[+2\]) with the appearance of the cellulite on her buttocks at the Day 71 visit. A positive change indicates an improvement in cellulite. |
| Change From Baseline in PR-CIS Total Score | 71 Days | Patient Reported Cellulite Impact Scale (PR-CIS) is a 6-item static questionnaire, each item is answered by a participant on a 11-level numerical rating scale that ranges from 0 (Not at all) to 10 (Extremely). The PR-CIS total score is the sum of individual item scores and can range from 0 to 60 with higher numbers reflecting a more negative impact from the cellulite. A responder was defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at an evaluation time point. A negative change from baseline indicates an improvement in cellulite severity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Day 71 | Q1 and Q4 are based on the ADA titer levels. |
| Serum Antibody Positivity by Visit | Day 1 - Day 71 | Percent of participants that are seropositive. Percentages were based on the number of subjects who had immunogenicity lab samples analyzed at the visit. |
| Overall Antibody Titer Levels by Visit | Day 1 - Day 71 | Descriptive statistics were based on log10 transformation of titer levels. Titer levels were imputed as 10 before the transformation if the reported level is \<10. Only seropositive participants are summarized. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Collagenase Clostridium Histolyticum (CCH) CCH 0.84 mg/Buttock 1.68 mg Total Dose | 210 |
| Placebo Placebo-control | 213 |
| Total | 423 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 0 | 1 |
| Overall Study | Adverse Event | 9 | 1 |
| Overall Study | Lost to Follow-up | 3 | 9 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 10 |
Baseline characteristics
| Characteristic | Collagenase Clostridium Histolyticum (CCH) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 47.9 years STANDARD_DEVIATION 10.33 | 45.8 years STANDARD_DEVIATION 9.84 | 46.9 years STANDARD_DEVIATION 10.13 |
| Body Mass Index (BMI) | 31.04 kg/m^2 STANDARD_DEVIATION 7.358 | 30.97 kg/m^2 STANDARD_DEVIATION 6.856 | 31.00 kg/m^2 STANDARD_DEVIATION 7.102 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 41 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 179 Participants | 172 Participants | 351 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 43 Participants | 90 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 157 Participants | 161 Participants | 318 Participants |
| Sex: Female, Male Female | 210 Participants | 213 Participants | 423 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) II (Fair) | 50 Participants | 48 Participants | 98 Participants |
| Skin Category (Fitzpatrick Scale) III (Darker White) | 69 Participants | 75 Participants | 144 Participants |
| Skin Category (Fitzpatrick Scale) I (Pale White) | 5 Participants | 4 Participants | 9 Participants |
| Skin Category (Fitzpatrick Scale) IV (Light Brown) | 40 Participants | 35 Participants | 75 Participants |
| Skin Category (Fitzpatrick Scale) V (Brown) | 33 Participants | 27 Participants | 60 Participants |
| Skin Category (Fitzpatrick Scale) VI (Dark Brown) | 13 Participants | 24 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 210 | 0 / 213 |
| other Total, other adverse events | 166 / 210 | 55 / 213 |
| serious Total, serious adverse events | 0 / 210 | 1 / 213 |
Outcome results
Primary
2-level Composite Responders for the Target Buttock
Number of of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe). A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder. A 2-level composite responder is defined as a participant with an improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock.
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 2-level Composite Responders for the Target Buttock | Yes: 2-Level Improvement | 16 Participants |
| Collagenase Clostridium Histolyticum (CCH) | 2-level Composite Responders for the Target Buttock | No: 2-Level Improvement | 194 Participants |
| Placebo | 2-level Composite Responders for the Target Buttock | Yes: 2-Level Improvement | 4 Participants |
| Placebo | 2-level Composite Responders for the Target Buttock | No: 2-Level Improvement | 209 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: 0.006Cochran-Mantel-Haenszel
Secondary
1-level Composite Responders of the Target Buttock
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe).
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 1-level Composite Responders of the Target Buttock | Yes | 78 Participants |
| Collagenase Clostridium Histolyticum (CCH) | 1-level Composite Responders of the Target Buttock | No | 132 Participants |
| Placebo | 1-level Composite Responders of the Target Buttock | Yes | 38 Participants |
| Placebo | 1-level Composite Responders of the Target Buttock | No | 175 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: <0.001Cochran-Mantel-Haenszel
Secondary
1-level PR-PCSS Responders of the Target Buttock
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe).
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 1-level PR-PCSS Responders of the Target Buttock | Yes | 114 Participants |
| Collagenase Clostridium Histolyticum (CCH) | 1-level PR-PCSS Responders of the Target Buttock | No | 96 Participants |
| Placebo | 1-level PR-PCSS Responders of the Target Buttock | Yes | 77 Participants |
| Placebo | 1-level PR-PCSS Responders of the Target Buttock | No | 136 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: <0.001Cochran-Mantel-Haenszel
Secondary
1-level S-GAIS Responders of Target Buttock
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from +3 (Very Much Improved) to -3 (Very Much Worse). Responders are defined as participants with at least ≥ 1-level improvement (Improved, Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 1-level S-GAIS Responders of Target Buttock | 135 Participants |
| Placebo | 1-level S-GAIS Responders of Target Buttock | 82 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: <0.001Cochran-Mantel-Haenszel
Secondary
1-level SSRS Responders
Subject Self-Rating Scale (SSRS) is a measure that assesses participant satisfaction with appearance in association with cellulite on the buttocks using whole numbers on a 7-level scale that ranges from 0 (Extremely Dissatisfied) to 6 (Extremely Satisfied). A 1-level SSRS responder is defined as a participant who is at least slightly satisfied (Slightly Satisfied \[4\], Very Satisfied \[5\], or Extremely Satisfied \[6\]) with the appearance of the cellulite on her buttocks at Day 71.
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 1-level SSRS Responders | 102 Participants |
| Placebo | 1-level SSRS Responders | 48 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: <0.001Cochran-Mantel-Haenszel
Secondary
2-level Composite Responder of the Non-target Buttock
Improvement in cellulite severity of the Non-target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe).
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 2-level Composite Responder of the Non-target Buttock | Yes | 16 Participants |
| Collagenase Clostridium Histolyticum (CCH) | 2-level Composite Responder of the Non-target Buttock | No | 194 Participants |
| Placebo | 2-level Composite Responder of the Non-target Buttock | Yes | 2 Participants |
| Placebo | 2-level Composite Responder of the Non-target Buttock | No | 211 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: <0.001Cochran-Mantel-Haenszel
Secondary
2-level PR-PCSS Responders of the Target Buttock
Improvement in cellulite severity of the Target Buttock from baseline of at least 2-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from 0 (None) to 4 (Severe).
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 2-level PR-PCSS Responders of the Target Buttock | Yes | 51 Participants |
| Collagenase Clostridium Histolyticum (CCH) | 2-level PR-PCSS Responders of the Target Buttock | No | 159 Participants |
| Placebo | 2-level PR-PCSS Responders of the Target Buttock | Yes | 26 Participants |
| Placebo | 2-level PR-PCSS Responders of the Target Buttock | No | 187 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: 0.001Cochran-Mantel-Haenszel
Secondary
2-level S-GAIS Responders of Target Buttock
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from +3 (Very Much Improved) to -3 (Very Much Worse). Responders are defined as participants with at least ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.
Time frame: Day 71
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 2-level S-GAIS Responders of Target Buttock | 49 Participants |
| Placebo | 2-level S-GAIS Responders of Target Buttock | 13 Participants |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: <0.001Cochran-Mantel-Haenszel
Secondary
Change From Baseline in PR-CIS Total Score
Patient Reported Cellulite Impact Scale (PR-CIS) is a 6-item static questionnaire, each item is answered by a participant on a 11-level numerical rating scale that ranges from 0 (Not at all) to 10 (Extremely). The PR-CIS total score is the sum of individual item scores and can range from 0 to 60 with higher numbers reflecting a more negative impact from the cellulite. A responder was defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at an evaluation time point. A negative change from baseline indicates an improvement in cellulite severity.
Time frame: 71 Days
Population: ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Change From Baseline in PR-CIS Total Score | Baseline (Day 1) | 51.1 score on a scale | Standard Deviation 8.86 |
| Collagenase Clostridium Histolyticum (CCH) | Change From Baseline in PR-CIS Total Score | Day 71 | 40.2 score on a scale | Standard Deviation 13.27 |
| Collagenase Clostridium Histolyticum (CCH) | Change From Baseline in PR-CIS Total Score | Change from Baseline | -10.9 score on a scale | Standard Deviation 12.51 |
| Placebo | Change From Baseline in PR-CIS Total Score | Baseline (Day 1) | 51.6 score on a scale | Standard Deviation 9.77 |
| Placebo | Change From Baseline in PR-CIS Total Score | Day 71 | 45.7 score on a scale | Standard Deviation 12.93 |
| Placebo | Change From Baseline in PR-CIS Total Score | Change from Baseline | -5.9 score on a scale | Standard Deviation 11.62 |
Comparison: CCH 0.84 mg/Buttock versus Placebop-value: <0.001ANCOVA
Secondary
PR-PCSS Rating for the Target and Non-target Buttock by Visit
The Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level photonumeric scale used by the patient (participant) to assess the severity of the participant's cellulite. The scale ratings range from 0 (None) to 4 (Severe).
Time frame: Day 1 to Day 71
Population: mITT Population includes all ITT participants with a baseline and at least 1 post-injection evaluation of both the CR-PCSS and PR-PCSS for both the target and nontarget buttocks. All secondary and supportive efficacy evaluations were based on the mITT Population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 84 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 120 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 81 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 0 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 117 Participants |
| Collagenase Clostridium Histolyticum (CCH) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 0 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 0 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 0 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 0 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 122 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 0 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 83 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 82 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 0 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 123 Participants |
| Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 0 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 1 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 0 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 29 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 79 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 78 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 0 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 2 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 27 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 81 Participants |
| Day 22: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 77 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 0 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 0 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 7 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 0 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 89 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 100 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 104 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 9 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 0 Participants |
| Day 22: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 95 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 50 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 13 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 75 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 50 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 1 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 50 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 45 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 12 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 0 Participants |
| Day 43: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 80 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 4 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 95 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 71 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 4 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 75 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 1 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 33 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 1 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 82 Participants |
| Day 43: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 24 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 20 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 65 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 1 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 40 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 25 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 54 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 55 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 0 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 45 Participants |
| Day 71: CCH | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 63 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 88 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 77 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 7 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 38 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 59 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 5 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 34 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 2 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 2 Participants |
| Day 71: Placebo | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 67 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 46 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 70 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 58 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 72 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 59 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 25 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 21 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 50 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 1 Participants |
| Day 71: CCH (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 0 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | None (0) | 2 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | None (0) | 2 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Almost None (1) | 5 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Almost None (1) | 7 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Mild (2) | 35 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Moderate (3) | 81 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Moderate (3) | 93 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Nontarget Buttock Rating | Severe (4) | 68 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Mild (2) | 40 Participants |
| Day 71: Placebo (LOCF) | PR-PCSS Rating for the Target and Non-target Buttock by Visit | Target Buttock Rating | Severe (4) | 77 Participants |
Secondary
Subjects Satisfaction With Cellulite Treatment at Day 71
A 1-level Subject Satisfaction responder is defined as a participant who is at least Satisfied (Satisfied \[+1\], or Very Satisfied \[+2\]) with the appearance of the cellulite on her buttocks at the Day 71 visit. A positive change indicates an improvement in cellulite.
Time frame: Day 71
Population: mITT Population includes all ITT participants with a baseline and at least 1 post-injection evaluation of both the CR-PCSS and PR-PCSS for both the target and nontarget buttocks. All secondary and supportive efficacy evaluations were based on the mITT Population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Subjects Satisfaction With Cellulite Treatment at Day 71 | Dissatisfied (-1) | 23 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subjects Satisfaction With Cellulite Treatment at Day 71 | Satisfied (+1) | 76 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Dissatisfied (-2) | 15 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subjects Satisfaction With Cellulite Treatment at Day 71 | Neither Satisfied Nor Dissatisfied (0) | 46 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Satisfied (+2) | 24 Participants |
| Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Neither Satisfied Nor Dissatisfied (0) | 56 Participants |
| Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Dissatisfied (-1) | 42 Participants |
| Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Dissatisfied (-2) | 43 Participants |
| Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Satisfied (+1) | 42 Participants |
| Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Satisfied (+2) | 7 Participants |
| Day 22: CCH | Subjects Satisfaction With Cellulite Treatment at Day 71 | Neither Satisfied Nor Dissatisfied (0) | 52 Participants |
| Day 22: CCH | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Satisfied (+2) | 24 Participants |
| Day 22: CCH | Subjects Satisfaction With Cellulite Treatment at Day 71 | Satisfied (+1) | 80 Participants |
| Day 22: CCH | Subjects Satisfaction With Cellulite Treatment at Day 71 | Dissatisfied (-1) | 23 Participants |
| Day 22: CCH | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Dissatisfied (-2) | 16 Participants |
| Day 22: Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Dissatisfied (-1) | 42 Participants |
| Day 22: Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Satisfied (+1) | 42 Participants |
| Day 22: Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Satisfied (+2) | 7 Participants |
| Day 22: Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Neither Satisfied Nor Dissatisfied (0) | 56 Participants |
| Day 22: Placebo | Subjects Satisfaction With Cellulite Treatment at Day 71 | Very Dissatisfied (-2) | 44 Participants |
Other Pre-specified
Overall Antibody Titer Levels by Visit
Descriptive statistics were based on log10 transformation of titer levels. Titer levels were imputed as 10 before the transformation if the reported level is \<10. Only seropositive participants are summarized.
Time frame: Day 1 - Day 71
Population: Safety Population includes all participants who received at least 1 dose of CCH in this study. All safety parameters were summarized based on this population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Overall Antibody Titer Levels by Visit | Day 43 positive | 4.639 log 10 titer | Standard Deviation 0.9961 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Antibody Titer Levels by Visit | Day 71 positive | 6.011 log 10 titer | Standard Deviation 0.6758 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Antibody Titer Levels by Visit | Day 22 positive | 2.561 log 10 titer | Standard Deviation 1.7812 |
| Collagenase Clostridium Histolyticum (CCH) | Overall Antibody Titer Levels by Visit | Day 1 positive | 4.396 log 10 titer | Standard Deviation 2.2644 |
| Placebo | Overall Antibody Titer Levels by Visit | Day 22 positive | 3.428 log 10 titer | Standard Deviation 2.3377 |
| Placebo | Overall Antibody Titer Levels by Visit | Day 43 positive | 2.597 log 10 titer | Standard Deviation 1.5802 |
| Placebo | Overall Antibody Titer Levels by Visit | Day 1 positive | 3.682 log 10 titer | Standard Deviation 2.2514 |
| Placebo | Overall Antibody Titer Levels by Visit | Day 71 positive | 1.845 log 10 titer | Standard Deviation 1.3931 |
| Day 22: CCH | Overall Antibody Titer Levels by Visit | Day 22 positive | 2.599 log 10 titer | Standard Deviation 2.1305 |
| Day 22: CCH | Overall Antibody Titer Levels by Visit | Day 1 positive | 4.366 log 10 titer | Standard Deviation 2.1658 |
| Day 22: CCH | Overall Antibody Titer Levels by Visit | Day 71 positive | 5.266 log 10 titer | Standard Deviation 0.7549 |
| Day 22: CCH | Overall Antibody Titer Levels by Visit | Day 43 positive | 3.706 log 10 titer | Standard Deviation 1.2138 |
| Day 22: Placebo | Overall Antibody Titer Levels by Visit | Day 71 positive | 1.927 log 10 titer | Standard Deviation 1.3274 |
| Day 22: Placebo | Overall Antibody Titer Levels by Visit | Day 43 positive | 2.052 log 10 titer | Standard Deviation 1.3049 |
| Day 22: Placebo | Overall Antibody Titer Levels by Visit | Day 1 positive | 2.478 log 10 titer | Standard Deviation 1.628 |
| Day 22: Placebo | Overall Antibody Titer Levels by Visit | Day 22 positive | 2.693 log 10 titer | Standard Deviation 1.7244 |
Other Pre-specified
Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles
Q1 and Q4 are based on the ADA titer levels.
Time frame: Day 71
Population: Safety Population includes all participants who received at least 1 dose of CCH in this study. All safety parameters were summarized based on this population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-I Antibody | Negative | 16 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-I Antibody | Positive | 8 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-II Antibody | Negative | 10 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-II Antibody | Positive | 13 Participants |
| Placebo | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-II Antibody | Positive | 23 Participants |
| Placebo | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-I Antibody | Negative | 0 Participants |
| Placebo | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-II Antibody | Negative | 0 Participants |
| Placebo | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-I Antibody | Positive | 24 Participants |
| Day 22: CCH | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-II Antibody | Positive | 36 Participants |
| Day 22: CCH | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-I Antibody | Positive | 32 Participants |
| Day 22: CCH | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-II Antibody | Negative | 10 Participants |
| Day 22: CCH | Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles | Neutralizing AUX-I Antibody | Negative | 16 Participants |
Other Pre-specified
Serum Antibody Positivity by Visit
Percent of participants that are seropositive. Percentages were based on the number of subjects who had immunogenicity lab samples analyzed at the visit.
Time frame: Day 1 - Day 71
Population: Safety Population includes all participants who received at least 1 dose of CCH in this study. All safety parameters were summarized based on this population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 1 | Seropositive | 12 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 1 | Seronegative | 197 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 22 | Seropositive | 97 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 22 | Seronegative | 90 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 43 | Seropositive | 186 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 43 | Seronegative | 2 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 71 | Seropositive | 185 Participants |
| Collagenase Clostridium Histolyticum (CCH) | Serum Antibody Positivity by Visit | Day 71 | Seronegative | 0 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 43 | Seronegative | 188 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 43 | Seropositive | 6 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 1 | Seronegative | 207 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 71 | Seronegative | 182 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 71 | Seropositive | 10 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 22 | Seronegative | 195 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 22 | Seropositive | 5 Participants |
| Placebo | Serum Antibody Positivity by Visit | Day 1 | Seropositive | 5 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 71 | Seropositive | 185 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 22 | Seropositive | 49 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 22 | Seronegative | 138 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 43 | Seropositive | 180 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 43 | Seronegative | 8 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 71 | Seronegative | 0 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 1 | Seropositive | 11 Participants |
| Day 22: CCH | Serum Antibody Positivity by Visit | Day 1 | Seronegative | 198 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 22 | Seropositive | 9 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 22 | Seronegative | 191 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 1 | Seronegative | 203 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 1 | Seropositive | 9 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 43 | Seropositive | 10 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 71 | Seronegative | 180 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 71 | Seropositive | 12 Participants |
| Day 22: Placebo | Serum Antibody Positivity by Visit | Day 43 | Seronegative | 184 Participants |