Real World CCH Study in Adult Females With Cellulite

• Sponsor: Endo Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04170296
• Collaborator: (none)
• Enrollment: 153
• Locations: 12
• Arms: 2
• Actual Duration (Months): 14.3
• Patients Per Site: 12.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite	Drug: EN3835	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females
• Actual Study Start Date: Nov 1, 2019
• Actual Primary Completion Date: Oct 6, 2020
• Actual Study Completion Date: Jan 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: Posterolateral Thigh EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)	Drug: EN3835; Collagenase Clostridium Histolyticum (CCH)
Experimental: Cohort 2: Buttocks EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)	Drug: EN3835; Collagenase Clostridium Histolyticum (CCH)

Outcome Measures

Primary Outcome Measures

1. The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh [90 Days]

   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".

2. The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock [90 Days]

   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".

Secondary Outcome Measures

1. Mean Change From Baseline in CR-PCSS for Each Buttock [Day 22, 43, 90 and 180]

   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.

2. Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score [Day 90, Day 180]

   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

3. Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score [Day 90, Day 180]

   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

4. The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh [Day 22, 43, and 180]

   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".

5. The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock [Day 22, 43, and 180]

   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".

6. Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) [Day 1, 90, and 180]

   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

7. Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) [Day 1, 90 and 180]

   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

8. Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) [Day 1, 90 and 180]

   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.

9. Presence of NAb Anti AUX-I and AUX-II (Buttocks) [Day 1, 90 and 180]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Have both buttocks or both posterolateral thighs with:

2. A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).

3. A Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 0 (absence of laxity, flaccidity, or sagging skin), or 1 (slightly draped appearance) at the Screening Visit only.

4. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.

5. Be judged to be in good health.

6. Have a negative pregnancy test.

7. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.

3. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.

4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.

5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.

6. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).

7. Requires anticoagulant or antiplatelet medication during the study.

8. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.

9. Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.

10. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.

11. Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant and/or to provide breast milk during the course of the study.

12. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endo Clinical Trial Site #2	Encino	California	United States	91436
2	Endo Clinical Trial Site #4	San Diego	California	United States	92121
3	Endo Clinical Trial Site #5	Solana Beach	California	United States	92075
4	Endo Clinical Trial Site #9	Westport	Connecticut	United States	00688
5	Endo Clinical Trial Site #1	Coral Gables	Florida	United States	33146
6	Endo Clinical Trial Site #10	Alpharetta	Georgia	United States	30005
7	Endo Clinical Trial Site #3	Chicago	Illinois	United States	60611
8	Endo Clinical Trial Site #11	Itasca	Illinois	United States	60143
9	Endo Clinical Trial Site #8	New Orleans	Louisiana	United States	70130
10	Endo Clinical Trial Site #6	New York	New York	United States	10021
11	Endo Clinical Trial Site #12	Nashville	Tennessee	United States	37215
12	Endo Clinical Trial Site #7	San Juan		Puerto Rico	00917

Sponsors and Collaborators

• Endo Pharmaceuticals

Investigators

• Study Director: David Hernandez, Endo Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - Jun 1, 2020
• Statistical Analysis Plan - Jul 22, 2020

More Information

Publications

None provided.

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04170296
• Other Study ID Numbers: EN3835-305
• First Posted: Nov 20, 2019
• Last Update Posted: Feb 22, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cellulite

Study Results

Participant Flow

Arm/Group Title	Cohort 1: Posterolateral Thigh	Cohort 2: Buttocks
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Period Title: Overall Study
STARTED	81	72
COMPLETED	73	68
NOT COMPLETED	8	4

Baseline Characteristics

Arm/Group Title	Cohort 1: Posterolateral Thigh	Cohort 2: Buttocks	Total
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	Total of all reporting groups
Overall Participants	81	72	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.2 (9.40)	42.7 (9.35)	43.0 (9.35)
Sex: Female, Male (Count of Participants)
Female	81 100%	72 100%	153 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 12.3%	18 25%	28 18.3%
Not Hispanic or Latino	71 87.7%	54 75%	125 81.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 2.5%	2 2.8%	4 2.6%
Native Hawaiian or Other Pacific Islander	1 1.2%	0 0%	1 0.7%
Black or African American	2 2.5%	2 2.8%	4 2.6%
White	74 91.4%	65 90.3%	139 90.8%
More than one race	0 0%	1 1.4%	1 0.7%
Unknown or Not Reported	2 2.5%	2 2.8%	4 2.6%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	65.082 (8.3341)	65.042 (8.9403)	65.063 (8.5961)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	164.548 (6.2671)	165.192 (6.6315)	164.851 (6.4279)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	24.03 (2.640)	23.89 (2.759)	23.96 (2.689)
Skin Category (Fitzpatrick Scale) (Count of Participants)
I (Pale White)	2 2.5%	1 1.4%	3 2%
II (Fair)	33 40.7%	24 33.3%	57 37.3%
III (Darker White)	24 29.6%	28 38.9%	52 34%
IV (Light Brown)	18 22.2%	14 19.4%	32 20.9%
V (Brown)	4 4.9%	4 5.6%	8 5.2%
VI (Dark Brown or Black)	0 0%	1 1.4%	1 0.7%

Outcome Measures

1. Primary Outcome

Title	The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Description	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".
Time Frame	90 Days

Outcome Measure Data

Analysis Population Description

Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation

Arm/Group Title	Cohort 1: Posterolateral Thigh
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	63
Count of Participants [Participants]	58 71.6%

2. Primary Outcome

Title	The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Description	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".
Time Frame	90 Days

Outcome Measure Data

Analysis Population Description

Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation

Arm/Group Title	Cohort 2: Buttocks
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	61
Count of Participants [Participants]	58 71.6%

3. Secondary Outcome

Title	Mean Change From Baseline in CR-PCSS for Each Buttock
Description	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.
Time Frame	Day 22, 43, 90 and 180

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cohort 2: Buttocks (Left)	Cohort 2: Buttocks (Right)
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	71	71
Day 22	-0.3 (0.52)	-0.3 (0.50)
Day 43	-0.6 (0.63)	-0.5 (0.59)
Day 90	-0.7 (0.70)	-0.7 (0.53)
Day 180	-0.7 (0.63)	-0.6 (0.63)

4. Secondary Outcome

Title	Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
Description	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
Time Frame	Day 90, Day 180

Outcome Measure Data

Analysis Population Description

Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.

Arm/Group Title	Cohort 1: Posterolateral Thigh
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	76
Day 90	10.9 (9.84)
Day 180	10.9 (9.76)

5. Secondary Outcome

Title	Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
Description	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
Time Frame	Day 90, Day 180

Outcome Measure Data

Analysis Population Description

Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.

Arm/Group Title	Cohort 2: Buttocks
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	71
Day 90	8.8 (8.38)
Day 180	8.8 (9.57)

6. Secondary Outcome

Title	The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Description	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".
Time Frame	Day 22, 43, and 180

Outcome Measure Data

Analysis Population Description

Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.

Arm/Group Title	Cohort 1: Posterolateral Thigh
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	76
Day 22	64 79%
Day 43	59 72.8%
Day 180	61 75.3%

7. Secondary Outcome

Title	The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Description	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".
Time Frame	Day 22, 43, and 180

Outcome Measure Data

Analysis Population Description

Evaluable Population includes all Participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation

Arm/Group Title	Cohort 2: Buttocks
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	71
Day 22	50 61.7%
Day 43	62 76.5%
Day 180	59 72.8%

8. Secondary Outcome

Title	Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Description	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
Time Frame	Day 1, 90, and 180

Outcome Measure Data

Analysis Population Description

Safety Population includes all participants who received at least 1 injection of study medication

Arm/Group Title	Cohort 1: Posterolateral Thigh (Anti AUX-I)	Cohort 1: Posterolateral Thigh (Anti AUX-II)
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	81	81
Day 1	5 6.2%	5 6.9%
Day 90	60 74.1%	60 83.3%
Day 180	68 84%	68 94.4%

9. Secondary Outcome

Title	Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Description	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
Time Frame	Day 1, 90 and 180

Outcome Measure Data

Analysis Population Description

Safety Population includes all participants who received at least 1 injection of study medication

Arm/Group Title	Cohort 2: Buttocks (Anti AUX-I)	Cohort 2: Buttocks (Anti AUX-II)
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	72	72
Day 1	7 8.6%	5 6.9%
Day 90	61 75.3%	61 84.7%
Day 180	66 81.5%	65 90.3%

10. Secondary Outcome

Title	Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Description	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.
Time Frame	Day 1, 90 and 180

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1: Posterolateral Thigh (Anti AUX-I)	Cohort 1: Posterolateral Thigh (Anti AUX-II)
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	13	17
Positive	1 1.2%	0 0%
Negative	1 1.2%	1 1.4%
Positive	13 16%	16 22.2%
Negative	0 0%	1 1.4%
Positive	8 9.9%	12 16.7%
Negative	3 3.7%	3 4.2%

11. Secondary Outcome

Title	Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Description	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.
Time Frame	Day 1, 90 and 180

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 2: Buttocks (Anti AUX-I)	Cohort 2: Buttocks (Anti AUX-II)
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
Measure Participants	17	13
Positive	2 2.5%	2 2.8%
Negative	0 0%	0 0%
Positive	15 18.5%	9 12.5%
Negative	2 2.5%	4 5.6%
Positive	15 18.5%	9 12.5%
Negative	2 2.5%	4 5.6%

Adverse Events

Time Frame	Time of informed consent signature until Day 180
Adverse Event Reporting Description	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
Arm/Group Title	Cohort 1: Posterolateral Thigh		Cohort 2: Buttocks
Arm/Group Description	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)		EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) EN3835: Collagenase Clostridium Histolyticum (CCH)
All Cause Mortality
	Cohort 1: Posterolateral Thigh		Cohort 2: Buttocks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/72 (0%)
Serious Adverse Events
	Cohort 1: Posterolateral Thigh		Cohort 2: Buttocks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1: Posterolateral Thigh		Cohort 2: Buttocks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	75/81 (92.6%)		69/72 (95.8%)
General disorders
Injection site bruising	70/81 (86.4%)	311	67/72 (93.1%)	327
Injection site dermatitis	0/81 (0%)	0	1/72 (1.4%)	1
Injection site discolouration	14/81 (17.3%)	32	24/72 (33.3%)	46
Injection site erythema	1/81 (1.2%)	1	0/72 (0%)	0
Injection site haemorrhage	3/81 (3.7%)	18	2/72 (2.8%)	12
Injection site mass	4/81 (4.9%)	7	5/72 (6.9%)	10
Injection site nodule	7/81 (8.6%)	17	5/72 (6.9%)	14
Injection site oedema	8/81 (9.9%)	34	5/72 (6.9%)	22
Injection site pain	53/81 (65.4%)	244	57/72 (79.2%)	298
Injection site pruritus	10/81 (12.3%)	37	14/72 (19.4%)	35
Injection site rash	1/81 (1.2%)	2	0/72 (0%)	0
Injection site reaction	2/81 (2.5%)	3	0/72 (0%)	0
Injection site swelling	12/81 (14.8%)	32	13/72 (18.1%)	34
Injection site warmth	1/81 (1.2%)	2	0/72 (0%)	0
Pyrexia	0/81 (0%)	0	1/72 (1.4%)	1
Immune system disorders
Drug hypersensitivity	1/81 (1.2%)	1	0/72 (0%)	0
Infections and infestations
Nasopharyngitis	2/81 (2.5%)	3	0/72 (0%)	0
Oral herpes	1/81 (1.2%)	2	0/72 (0%)	0
Sinusitis	1/81 (1.2%)	1	0/72 (0%)	0
Urinary tract infection	2/81 (2.5%)	2	1/72 (1.4%)	1
Injury, poisoning and procedural complications
Thermal burn	1/81 (1.2%)	1	0/72 (0%)	0
Investigations
Alanine aminotransferase increased	1/81 (1.2%)	1	0/72 (0%)	0
Aspartate aminotransferase increased	1/81 (1.2%)	1	0/72 (0%)	0
Blood potassium increased	0/81 (0%)	0	1/72 (1.4%)	1
Blood sodium increased	1/81 (1.2%)	1	0/72 (0%)	0
Blood urine present	1/81 (1.2%)	1	0/72 (0%)	0
Coronavirus test positive	0/81 (0%)	0	1/72 (1.4%)	1
Hepatic enzyme increased	1/81 (1.2%)	1	0/72 (0%)	0
Nitrite urine present	0/81 (0%)	0	1/72 (1.4%)	1
Urine ketone body present	1/81 (1.2%)	1	0/72 (0%)	0
Urine leukocyte esterase positive	0/81 (0%)	0	1/72 (1.4%)	1
White blood cell count increased	1/81 (1.2%)	1	1/72 (1.4%)	1
Musculoskeletal and connective tissue disorders
Pain in extremity	1/81 (1.2%)	1	0/72 (0%)	0
Nervous system disorders
Dizziness	1/81 (1.2%)	1	0/72 (0%)	0
Migraine	1/81 (1.2%)	1	0/72 (0%)	0
Psychiatric disorders
Anxiety	1/81 (1.2%)	1	0/72 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/81 (0%)	0	1/72 (1.4%)	1
Skin and subcutaneous tissue disorders
Diffuse alopecia	0/81 (0%)	0	1/72 (1.4%)	1
Post-inflammatory pigmentation change	5/81 (6.2%)	10	2/72 (2.8%)	4
Vascular disorders
Hypertension	1/81 (1.2%)	1	0/72 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.