A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum \[CCH\]-aaes) lasts in the treatment of Cellulite.
This study included participants who completed EN3835-302 (NCT03428750) or EN3835-303 (NCT03446781) double-blind parent studies. The first part of this study consisted of an observational period conducted in a blinded fashion and where no treatments were administered between Day 71 of the parent studies and Day 180 in this Open-label extension study. Once these participants were unblinded at Day 180, only participants who received active CCH-aaes in the parent studies remained in this study and those who received placebo in the parent studies were not eligible to continue in the Open-label study. Assessments made at the Day 71/(End of Study \[EOS\]) visit of the parent studies served as initial screening assessments for this study. In the Open-label Phase of the study, all participants who qualified for, and opted for, retreatment were administered CCH-aaes at 3 treatment sessions at 21-day intervals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
483
Administered to participants who qualified for, and opted for, retreatment.
No treatment administered during 180 days of observation.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to Day 1080
Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment
Serum samples were analyzed for ADAs. The percentage of participants who developed ADAs (seropositive results) during the Open-label Phase of the study are reported.
Time frame: From Day 180 (Open-label Phase) up to Day 1080
Time to 2-Level Reduction of Response in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in PR-PCSS and CR-PCSS to the time at which a 2-level composite worsening of response was observed for the first time.
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which 1-level composite worsening of response was observed for the first time.
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Endo Clinical Trial Site #3
Glendale, Arizona, United States
Endo Clinical Trial Site #11
Scottsdale, Arizona, United States
Endo Clinical Trial Site #41
North Little Rock, Arkansas, United States
Endo Clinical Trial Site #14
Encinitas, California, United States
Endo Clinical Trial Site #9
Long Beach, California, United States
Endo Clinical Trial Site #35
Murrieta, California, United States
Endo Clinical Trial Site #42
Newport Beach, California, United States
Endo Clinical Trial Site #17
Oceanside, California, United States
Endo Clinical Trial Site #39
San Diego, California, United States
Endo Clinical Trial Site #23
Greenwood Village, Colorado, United States
...and 32 more locations
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to Complete Loss of Response in CR-PCSS and PR-PCSS
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Complete loss of response is defined as both CR-PCSS and PR-PCSS ratings returned to the baseline severity of the double-blind study or worse for both the buttocks. Time to complete loss of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which complete loss of response was observed for the first time.
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080