Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
- Conditions
- CelluliteEdematous Fibrosclerotic Panniculopathy
- Interventions
- Biological: CCH-aaesOther: Observation
- Registration Number
- NCT03526549
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 483
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CCH-aaes Treatment in Parent Studies (EN3835-302/303) CCH-aaes Participants who received CCH-aaes treatment in EN3835-302/303 were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and entered the Open-label Phase of the study. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals. CCH-aaes Treatment in Parent Studies (EN3835-302/303) Observation Participants who received CCH-aaes treatment in EN3835-302/303 were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and entered the Open-label Phase of the study. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals. Placebo Treatment in Parent Studies (EN3835-302/303) Observation Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued. No treatment was administered.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) Up to Day 1080 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.
Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment From Day 180 (Open-label Phase) up to Day 1080 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.
- Secondary Outcome Measures
Name Time Method Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS From Day 180 (Open-label Observation Phase) up to Day 1080 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.
Time to Complete Loss of Response in CR-PCSS and PR-PCSS From Day 180 (Open-label Observation Phase) up to Day 1080 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 to 2-Level Reduction of Response in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) From Day 180 (Open-label Observation Phase) up to Day 1080 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.
Trial Locations
- Locations (42)
Endo Clinical Trial Site #39
🇺🇸San Diego, California, United States
Endo Clinical Trial Site #27
🇺🇸Miami, Florida, United States
Endo Clinical Trial Site #36
🇺🇸Miami, Florida, United States
Endo Clinical Trial Site #13
🇺🇸Houston, Texas, United States
Endo Clinical Trial Site #7
🇺🇸Houston, Texas, 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 #10
🇺🇸New Orleans, Louisiana, United States
Endo Clinical Trial Site #4
🇺🇸Omaha, Nebraska, United States
Endo Clinical Trial Site #19
🇺🇸Meridian, Idaho, United States
Endo Clinical Trial Site #16
🇺🇸Metairie, Louisiana, United States
Endo Clinical Trial Site #3
🇺🇸Glendale, Arizona, United States
Endo Clinical Trial Site #9
🇺🇸Long Beach, California, United States
Endo Clinical Trial Site #23
🇺🇸Greenwood Village, Colorado, 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 #14
🇺🇸Encinitas, California, United States
Endo Clinical Trial Site #17
🇺🇸Oceanside, California, United States
Endo Clinical Trial Site #38
🇺🇸Boca Raton, Florida, United States
Endo Clinical Trial Site #8
🇺🇸Coral Gables, Florida, United States
Endo Clinical Trial Site #40
🇺🇸Largo, Florida, United States
Endo Clinical Trial Site #20
🇺🇸Snellville, Georgia, United States
Endo Clinical Trial Site #34
🇺🇸Chicago, Illinois, United States
Endo Clinical Trial Site #30
🇺🇸Indianapolis, Indiana, United States
Endo Clinical Trial Site #25
🇺🇸New Orleans, Louisiana, United States
Endo Clinical Trial Site #33
🇺🇸Quincy, Massachusetts, United States
Endo Clinical Trial Site #18
🇺🇸Washington, Missouri, United States
Endo Clinical Trial Site #12
🇺🇸New York, New York, United States
Endo Clinical Trial Site #24
🇺🇸Mount Kisco, New York, United States
Endo Clinical Trial Site #26
🇺🇸Cincinnati, Ohio, United States
Endo Clinical Trial Site #32
🇺🇸New York, New York, United States
Endo Clinical Trial Site #29
🇺🇸New York, New York, United States
Endo Clinical Trial Site #15
🇺🇸New York, New York, United States
Endo Clinical Trial Site #5
🇺🇸Nashville, Tennessee, United States
Endo Clinical Trial Site #6
🇺🇸Beaumont, Texas, United States
Endo Clinical Trial Site #37
🇺🇸Sugar Land, Texas, United States
Endo Clinical Trial Site #28
🇺🇸Pflugerville, Texas, United States
Endo Clinical Trial Site #21
🇺🇸San Antonio, Texas, United States
Endo Clinical Trial Site #31
🇺🇸Salt Lake City, Utah, United States
Endo Clinical Trial Site #1
🇺🇸Charlottesville, Virginia, United States
Endo Clinical Trial Site #2
🇺🇸Lynchburg, Virginia, United States
Endo Clinical Trial Site #22
🇺🇸Austin, Texas, United States