Trial Outcomes & Findings for EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) (NCT NCT02942160)
NCT ID: NCT02942160
Last Updated: 2020-11-24
Results Overview
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.
COMPLETED
PHASE2
259 participants
Day 180 to Day 360
2020-11-24
Participant Flow
Participant milestones
| Measure |
EN3835 Treated Participants in EN3835-202
Observation Phase (259 Started \& 222 Completed):
Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201
EN3835 Treated Participants in EN3835-202:
Buttock \& Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum
|
|---|---|
|
Overall Study
STARTED
|
259
|
|
Overall Study
EN3835-202 Participants
|
222
|
|
Overall Study
EN3835 Treated Subjects in EN3835-202
|
200
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
103
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Baseline characteristics by cohort
| Measure |
EN3835 Treatment Regions
n=200 Participants
Buttock \& Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum
|
|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
173 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.3 kg/m^2
STANDARD_DEVIATION 6.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 180 to Day 360Population: The Durability Population for Double-blind Treated Participants is defined as all participants in the Overall Durability Population for both who showed an improvement on Day 71 of at least 2-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=19 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Visit Day 180 · Yes
|
19 Participants
|
—
|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Visit Day 180 · No
|
0 Participants
|
—
|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Visit Day 360 · Yes
|
16 Participants
|
—
|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Visit Day 360 · No
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 180 to Day 360Population: The Durability Population for Double-blind Treated Participants is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=53 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Durability Visit Day 180 · Yes
|
50 Participants
|
—
|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Durability Visit Day 180 · No
|
3 Participants
|
—
|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Durability Visit Day 360 · Yes
|
43 Participants
|
—
|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Observation Durability Visit Day 360 · No
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 540 to Day 720Population: The Durability Population for Double-blind Treated Participants, defined as all participants who showed an improvement on Day 71 of at least 2-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201), and had an Observation at Day 540.
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).
Outcome measures
| Measure |
EN3835 Treatment Regions
n=7 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 540 · Yes
|
7 Participants
|
—
|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 540 · No
|
0 Participants
|
—
|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 720 · Yes
|
7 Participants
|
—
|
|
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 720 · No
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 540 to Day 720Population: The Durability Population for Double-blind Treated Participants, defined as all participants who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201), and had an Observation at Day 540.
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).
Outcome measures
| Measure |
EN3835 Treatment Regions
n=23 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 540 · Yes
|
22 Participants
|
—
|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 540 · No
|
1 Participants
|
—
|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 720 · Yes
|
21 Participants
|
—
|
|
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Long-term Durability Visit Day 720 · No
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (in EN3835-201 Study) to Observation Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=121 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
n=138 Participants
Placebo in Study EN3835-201
|
|---|---|---|
|
CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
Change from Baseline on Day 71 (EN3835-201 Study)
|
-0.8 score on a scale
Standard Deviation 0.88
|
-0.3 score on a scale
Standard Deviation 0.60
|
|
CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
Change from Baseline-Observation Visit Day 180
|
-0.6 score on a scale
Standard Deviation 0.80
|
-0.2 score on a scale
Standard Deviation 0.67
|
|
CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
Change from Baseline-Observation Visit Day 270
|
-0.6 score on a scale
Standard Deviation 0.76
|
-0.1 score on a scale
Standard Deviation 0.63
|
|
CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
Change from Baseline-Observation Visit Day 360
|
-0.9 score on a scale
Standard Deviation 0.86
|
-0.5 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Day 22 to Day 360Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=162 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Change from Baseline (BL) to Treatment Day 22
|
-0.6 score on a scale
Standard Deviation 0.68
|
—
|
|
CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Change from Baseline (BL) to Treatment Day 43
|
-0.8 score on a scale
Standard Deviation 0.71
|
—
|
|
CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Change from Baseline (BL) to Treatment Day 71
|
-1.0 score on a scale
Standard Deviation 0.79
|
—
|
|
CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Change from BL to Treatment Observation Day 180
|
-1.0 score on a scale
Standard Deviation 0.80
|
—
|
|
CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Change from BL to Treatment Observation Day 360
|
-0.9 score on a scale
Standard Deviation 0.77
|
—
|
SECONDARY outcome
Timeframe: Day 22 to Day 360Population: Effectiveness Population
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=162 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
Change from Baseline (BL) to Treatment Day 22
|
-0.5 score on a scale
Standard Deviation 0.64
|
—
|
|
PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
Change from Baseline (BL) to Treatment Day 43
|
-0.8 score on a scale
Standard Deviation 0.75
|
—
|
|
PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
Change from Baseline (BL) to Treatment Day 71
|
-1.1 score on a scale
Standard Deviation 0.82
|
—
|
|
PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
Change from BL to Treatment Observation Day 180
|
-1.0 score on a scale
Standard Deviation 0.83
|
—
|
|
PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
Change from BL to Treatment Observation Day 360
|
-1.0 score on a scale
Standard Deviation 0.83
|
—
|
SECONDARY outcome
Timeframe: Baseline (in EN3835-201 Study) to Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=121 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
n=138 Participants
Placebo in Study EN3835-201
|
|---|---|---|
|
Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
Observation Visit Day 360
|
8.6 score on a scale
Standard Deviation 2.40
|
9.5 score on a scale
Standard Deviation 1.35
|
|
Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
Change from Baseline (Day 360)
|
-2.2 score on a scale
Standard Deviation 2.34
|
-1.2 score on a scale
Standard Deviation 1.47
|
|
Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
Baseline Point (in EN3835-201 Study)
|
10.7 score on a scale
Standard Deviation 1.32
|
10.4 score on a scale
Standard Deviation 1.41
|
|
Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
Day 71 Reference Point (in EN3835 Study)
|
9.0 score on a scale
Standard Deviation 2.42
|
9.7 score on a scale
Standard Deviation 2.20
|
|
Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
Change from Baseline (Day 71)
|
-1.8 score on a scale
Standard Deviation 2.22
|
-0.8 score on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Day 540 to Day 720Population: Durability Population in Double-blind Treated Participants is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).
The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. A negative change from baseline indicates an improvement in cellulite severity.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=53 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits
Baseline (in EN3835-201 Study)
|
10.6 score on a scale
Standard Deviation 1.43
|
—
|
|
Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits
Long-term Durability Visit Day 540-Change from BL
|
-3.5 score on a scale
Standard Deviation 1.76
|
—
|
|
Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits
Long-term Durability Visit Day 720-Change from BL
|
-2.9 score on a scale
Standard Deviation 1.74
|
—
|
SECONDARY outcome
Timeframe: Baseline - Day 360Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in the current study.
The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3". The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. Change from baseline is the visit total score minus baseline total score. A negative change from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=162 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Baseline
|
10.5 score on a scale
Standard Deviation 1.44
|
—
|
|
Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Day 71
|
8.3 score on a scale
Standard Deviation 2.41
|
—
|
|
Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Change from Baseline
|
-2.2 score on a scale
Standard Deviation 2.32
|
—
|
|
Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835: Treatment Observation Day 360
|
8.1 score on a scale
Standard Deviation 2.51
|
—
|
|
Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835: Change from Baseline
|
-2.4 score on a scale
Standard Deviation 2.37
|
—
|
SECONDARY outcome
Timeframe: Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=97 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
n=19 Participants
Placebo in Study EN3835-201
|
|---|---|---|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Very Much Improved (3)
|
4 Participants
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Much Improved (2)
|
23 Participants
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Improved (1)
|
36 Participants
|
4 Participants
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
No Change (0)
|
32 Participants
|
14 Participants
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Worse (-1)
|
2 Participants
|
1 Participants
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Much Worse (-2)
|
0 Participants
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Very Much Worse (-3)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 71 - Day 360Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in the current study.
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment course in Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=162 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Very Much Improved (3)
|
10 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Much Improved (2)
|
38 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Improved (1)
|
73 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · No Change (0)
|
35 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Worse (-1)
|
3 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Much Worse (-2)
|
0 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Very Much Worse (-3)
|
0 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Very Much Improved (3)
|
5 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Much Improved (2)
|
33 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Improved (1)
|
64 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · No Change (0)
|
31 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Worse (-1)
|
7 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Much Worse (-2)
|
2 Participants
|
—
|
|
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Very Much Worse (-3)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201
Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in S-GAIS indicates an improvement. Percentages are based on the number of all evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=97 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
n=19 Participants
Placebo in Study EN3835-201
|
|---|---|---|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Very Much Improved (3)
|
3 Participants
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Much Improved (2)
|
18 Participants
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Improved (1)
|
46 Participants
|
4 Participants
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
No Change (0)
|
23 Participants
|
14 Participants
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Worse (-1)
|
5 Participants
|
1 Participants
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Much Worse (-2)
|
0 Participants
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Very Much Worse (-3)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 71 - Day 360Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.
Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in EN3835-202 Study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=162 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Very Much Improved (3)
|
16 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Much Improved (2)
|
33 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Improved (1)
|
69 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · No Change (0)
|
32 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Worse (-1)
|
7 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Much Worse (-2)
|
1 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Very Much Worse (-3)
|
1 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Very Much Improved (3)
|
16 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Much Improved (2)
|
14 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Improved (1)
|
64 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · No Change (0)
|
39 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Worse (-1)
|
7 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Much Worse (-2)
|
3 Participants
|
—
|
|
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Second EN3835 Tx: Treatment Observation Day 360 · Very Much Worse (-3)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201
Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. (EFP = Edematous Fibrosclerotic Panniculopathy, aka Cellulite)
Outcome measures
| Measure |
EN3835 Treatment Regions
n=97 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
n=19 Participants
Placebo in Study EN3835-201
|
|---|---|---|
|
Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
Very Satisfied with Treatment (2)
|
14 Participants
|
0 Participants
|
|
Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
Satisfied with Treatment (1)
|
41 Participants
|
4 Participants
|
|
Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
Neither Dissatisfied nor Satisfied with Tretmt (0)
|
23 Participants
|
11 Participants
|
|
Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
Dissatisfied with Treatment (-1)
|
14 Participants
|
4 Participants
|
|
Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
Very Dissatisfied with Treatment (-2)
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 71 - Day 360Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.
Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=162 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Very Satisfied wth Treatment (2)
|
34 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Satisfied with Treatment (1)
|
67 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Neither Dissatisfied nor Satisfied with Tx (0)
|
36 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Dissatisfied with Treatment (-1)
|
13 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Day 71 · Very Dissatisfied with Treatment (-2)
|
9 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Obsv Day 360 · Very Satisfied wth Treatment (2)
|
25 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Obsv Day 360 · Satisfied with Treatment (1)
|
50 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Obsv Day 360 · Neither Dissatisfied nor Satisfied with Tx (0)
|
45 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Obsv Day 360 · Dissatisfied with Treatment (-1)
|
16 Participants
|
—
|
|
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Second EN3835 Treatment: Treatment Obsv Day 360 · Very Dissatisfied with Treatment (-2)
|
7 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201 (259 participants in Observation Phase). Included all participants with collected samples at Day 360.
Percent of participants that are seropositive. Descriptive statistics are based on log10 transformation of titer levels. Percent is based on the number of subjects who had immunogenicity lab samples drawn at the visit
Outcome measures
| Measure |
EN3835 Treatment Regions
n=19 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
n=4 Participants
Placebo in Study EN3835-201
|
|---|---|---|
|
Overall Serum Antibody at Observation Visit Day 360
anti-AUX-I: Observation Visit Day 360 · Seropositive
|
17 Participants
|
2 Participants
|
|
Overall Serum Antibody at Observation Visit Day 360
anti-AUX-I: Observation Visit Day 360 · Seronegative
|
2 Participants
|
2 Participants
|
|
Overall Serum Antibody at Observation Visit Day 360
anti-AUX-II: Observation Visit Day 360 · Seropositive
|
16 Participants
|
2 Participants
|
|
Overall Serum Antibody at Observation Visit Day 360
anti-AUX-II: Observation Visit Day 360 · Seronegative
|
3 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase). Included Seropositive participants at Day 360.
Descriptive statistics are based on log10 transformation of titer levels.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=17 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
n=2 Participants
Placebo in Study EN3835-201
|
|---|---|---|
|
Overall Antibody Log Titer Levels at Observation Visit Day 360
anti-AUX-I: Observation Visit Day 360 positive
|
3.085 log 10 titer
Standard Deviation 1.192
|
2.576 log 10 titer
Standard Deviation 0.213
|
|
Overall Antibody Log Titer Levels at Observation Visit Day 360
anti-AUX-II: Observation Visit Day 360 positive
|
3.175 log 10 titer
Standard Deviation 1.239
|
1.547 log 10 titer
Standard Deviation 0.315
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 360Population: Observation Population included all participants who rolled over from Study EN3835-201 (259 participants in Observation Phase).Included Seropositive participants at Day 360.
Participants with binding antibodies were tested for neutralizing antibodies.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=23 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Neutralizing Antibodies at Observation Visit Day 360
Neutralizing AUX-I Antibody · Negative
|
5 Participants
|
—
|
|
Neutralizing Antibodies at Observation Visit Day 360
Neutralizing AUX-I Antibody · Positive
|
13 Participants
|
—
|
|
Neutralizing Antibodies at Observation Visit Day 360
Neutralizing AUX-II Antibody · Negative
|
14 Participants
|
—
|
|
Neutralizing Antibodies at Observation Visit Day 360
Neutralizing AUX-II Antibody · Positive
|
9 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 360Population: Safety Population included participants with seropositive antibody results
Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels.
Outcome measures
| Measure |
EN3835 Treatment Regions
n=163 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
anti-AUX-I: Treatment Day 1 positive
|
4.038 Log 10 titer
Standard Deviation 0.697
|
—
|
|
Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
anti-AUX-I: Treatment Day 71 positive
|
6.268 Log 10 titer
Standard Deviation 0.786
|
—
|
|
Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
anti-AUX-I: Treatment Observation Day 360 positive
|
4.964 Log 10 titer
Standard Deviation 0.584
|
—
|
|
Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
anti-AUX-II: Treatment Day 1 positive
|
3.853 Log 10 titer
Standard Deviation 0.854
|
—
|
|
Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
anti-AUX-II: Treatment Day 71 positive
|
5.832 Log 10 titer
Standard Deviation 0.736
|
—
|
|
Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
anti-AUX-II: Treatment Observation Day 360 positiv
|
4.714 Log 10 titer
Standard Deviation 0.635
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 71 to Day 360Population: Safety Population included participants with observed antibody levels at Day 71 in Q1 and Q4
Tx Obs = Treatment Observation
Outcome measures
| Measure |
EN3835 Treatment Regions
n=38 Participants
Buttocks \& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
Placebo
Placebo in Study EN3835-201
|
|---|---|---|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Treatment Day 71: Neutralizing AUX-I Antibody · Negative
|
2 Participants
|
—
|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Treatment Day 71: Neutralizing AUX-I Antibody · Positive
|
36 Participants
|
—
|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Treatment Day 71: Neutralizing AUX-II Antibody · Negative
|
10 Participants
|
—
|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Treatment Day 71: Neutralizing AUX-II Antibody · Positive
|
25 Participants
|
—
|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Tx Obs Day 360: Neutralizing AUX-I Antibody · Negative
|
21 Participants
|
—
|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Tx Obs Day 360: Neutralizing AUX-I Antibody · Positive
|
15 Participants
|
—
|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Tx Obs Day 360: Neutralizing AUX-II Antibody · Negative
|
32 Participants
|
—
|
|
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Tx Obs Day 360: Neutralizing AUX-II Antibody · Positive
|
3 Participants
|
—
|
Adverse Events
Observation Phase
EN3835 Treatment Phase
Serious adverse events
| Measure |
Observation Phase
n=259 participants at risk
Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201
|
EN3835 Treatment Phase
n=200 participants at risk
Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
0.50%
1/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
0.50%
1/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous Miscarriage
|
0.39%
1/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
0.00%
0/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
0.50%
1/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
Injury, poisoning and procedural complications
Death from Motor Vehicle Accident
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
0.50%
1/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
Other adverse events
| Measure |
Observation Phase
n=259 participants at risk
Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201
|
EN3835 Treatment Phase
n=200 participants at risk
Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
|
|---|---|---|
|
General disorders
Injection site bruising
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
85.0%
170/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
General disorders
Injection site pain
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
56.5%
113/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
General disorders
Injection site nodule
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
19.5%
39/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
General disorders
Injection site pruritus
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
16.5%
33/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
General disorders
Injection site swelling
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
9.5%
19/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
General disorders
Injection site discolouration
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
9.0%
18/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/259 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
5.5%
11/200 • All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
All (serious and nonserious) AEs, whether elicited or observed during study visits 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. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place