Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).
Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Experimental | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) |
|
| Cohort 2: Buttocks | Experimental | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EN3835 | Drug | Collagenase Clostridium Histolyticum (CCH) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | 90 Days |
| The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in CR-PCSS for Each Buttock | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective. | Day 22, 43, 90 and 180 |
| Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score |
Not provided
Inclusion Criteria:
Have both buttocks or both posterolateral thighs with:
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
Be judged to be in good health.
Have a negative pregnancy test.
Be willing and able to cooperate with the requirements of the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Hernandez | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #2 | Encino | California | 91436 | United States | ||
| Endo Clinical Trial Site #4 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Posterolateral Thigh | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH) |
| FG001 | Cohort 2: Buttocks | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2020 | Oct 6, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center |
| Day 90, Day 180 |
| Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score | The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center | Day 90, Day 180 |
| The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | Day 22, 43, and 180 |
| The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | Day 22, 43, and 180 |
| Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses | Day 1, 90, and 180 |
| Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses | Day 1, 90 and 180 |
| Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. | Day 1, 90 and 180 |
| Presence of NAb Anti AUX-I and AUX-II (Buttocks) | All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. | Day 1, 90 and 180 |
| San Diego |
| California |
| 92121 |
| United States |
| Endo Clinical Trial Site #5 | Solana Beach | California | 92075 | United States |
| Endo Clinical Trial Site #9 | Westport | Connecticut | 00688 | United States |
| Endo Clinical Trial Site #1 | Coral Gables | Florida | 33146 | United States |
| Endo Clinical Trial Site #10 | Alpharetta | Georgia | 30005 | United States |
| Endo Clinical Trial Site #3 | Chicago | Illinois | 60611 | United States |
| Endo Clinical Trial Site #11 | Itasca | Illinois | 60143 | United States |
| Endo Clinical Trial Site #8 | New Orleans | Louisiana | 70130 | United States |
| Endo Clinical Trial Site #6 | New York | New York | 10021 | United States |
| Endo Clinical Trial Site #12 | Nashville | Tennessee | 37215 | United States |
| Endo Clinical Trial Site #7 | San Juan | 00917 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population includes all participants who have at least 1 injection of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Posterolateral Thigh | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH) |
| BG001 | Cohort 2: Buttocks | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Skin Category (Fitzpatrick Scale) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation | Posted | Count of Participants | Participants | 90 Days |
|
|
| ||||||||||||||||||||||||||
| Primary | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation | Posted | Count of Participants | Participants | 90 Days |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CR-PCSS for Each Buttock | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective. | Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation. Number of participants analyzed are evaluable population participants that had a change from baseline at the specified visit | Posted | Mean | Standard Deviation | units on a scale | Day 22, 43, 90 and 180 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score | The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center | Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation. | Posted | Mean | Standard Deviation | units on a scale | Day 90, Day 180 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score | The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center | Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation. | Posted | Mean | Standard Deviation | units on a scale | Day 90, Day 180 |
|
| ||||||||||||||||||||||||||
| Secondary | The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation. | Posted | Count of Participants | Participants | Day 22, 43, and 180 |
|
| |||||||||||||||||||||||||||
| Secondary | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved". | Evaluable Population includes all Participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation | Posted | Count of Participants | Participants | Day 22, 43, and 180 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses | Safety Population includes all participants who received at least 1 injection of study medication | Posted | Count of Participants | Participants | Day 1, 90, and 180 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses | Safety Population includes all participants who received at least 1 injection of study medication | Posted | Count of Participants | Participants | Day 1, 90 and 180 |
|
| |||||||||||||||||||||||||||
| Secondary | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. | Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit. | Posted | Count of Participants | Participants | Day 1, 90 and 180 |
| ||||||||||||||||||||||||||||
| Secondary | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. | Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit. | Posted | Count of Participants | Participants | Day 1, 90 and 180 |
|
|
Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Posterolateral Thigh | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH) | 0 | 81 | 0 | 81 | 75 | 81 |
| EG001 | Cohort 2: Buttocks | EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH) | 0 | 72 | 0 | 72 | 69 | 72 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site dermatitis | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Coronavirus test positive | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Nitrite urine present | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Urine ketone body present | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diffuse alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Post-inflammatory pigmentation change | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hernandez, MD | Endo Pharmaceuticals | 800-462-3636 | clinicaltrials@endo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2020 | Oct 6, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| II (Fair) |
|
| III (Darker White) |
|
| IV (Light Brown) |
|
| V (Brown) |
|
| VI (Dark Brown or Black) |
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Negative |
|
| Negative |
|
| Negative |
|
| Negative |
|