Clinical trial NCT03526549: Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
Official title: A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Edematous Fibrosclerotic Panniculopathy
Cellulite
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 483
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria

All Participants (Through Day 180):

1. Voluntarily sign and date an informed consent agreement
2. Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303
3. Be willing to apply sunscreen to the buttocks before each exposure to the sun and/or tanning booths while participating in the study
4. Be judged to be in good health
5. Be willing and able to cooperate with the requirements of the study
6. Be able to read, complete and understand the participant reported outcomes rating instruments in English.

Key Inclusion Criteria for Participants Eligible for Retreatment:

1. Have a negative pregnancy test and using a stable and effective contraception method.

Key Exclusion Criteria

All Participants (Through Day 180):

1. Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
2. Intends to use tanning spray or tanning booths during this period
3. Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
4. Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for the study

Additional Exclusion Criteria may apply Post Day 180:

1. Has received any collagenase treatments at any time since completion of the double-blind study (EN3835-302 or EN3835-303).

Key Exclusion Criteria for Participants Eligible for Retreatment:

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

* Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, skin laxity, flaccidity and/or skin sagging, active cutaneous alteration, tattoo/mole) that restricts study participation
* Requires anticoagulant or antiplatelet medication during the study
* Prior to and during the course of retreatment, is nursing or providing breast milk in any manner, intends to become pregnant during the study, or intends to use tanning spray or tanning booths during the study
* Has received an investigational drug or treatment, other than treatment in study EN3835-302/303, within 30 days before retreatment with study drug
* Has a known systemic allergy to collagenase or any other excipient of study drug
* Has received any collagenase treatments at any time since completion of the double-blind study
* Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for retreatment

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 1080
measure: Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment
timeFrame: From Day 180 (Open-label Phase) up to Day 1080
Secondary outcomes:
measure: 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)
timeFrame: From Day 180 (Open-label Observation Phase) up to Day 1080
measure: Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS
timeFrame: From Day 180 (Open-label Observation Phase) up to Day 1080
measure: Time to Complete Loss of Response in CR-PCSS and PR-PCSS
timeFrame: From Day 180 (Open-label Observation Phase) up to Day 1080
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Endo Clinical Trial Site #3
state: Arizona
city: Scottsdale
country: United States
facility: Endo Clinical Trial Site #11
state: Arizona
city: North Little Rock
country: United States
facility: Endo Clinical Trial Site #41
state: Arkansas
city: Encinitas
country: United States
facility: Endo Clinical Trial Site #14
state: California
city: Long Beach
country: United States
facility: Endo Clinical Trial Site #9
state: California
city: Murrieta
country: United States
facility: Endo Clinical Trial Site #35
state: California
city: Newport Beach
country: United States
facility: Endo Clinical Trial Site #42
state: California
city: Oceanside
country: United States
facility: Endo Clinical Trial Site #17
state: California
city: San Diego
country: United States
facility: Endo Clinical Trial Site #39
state: California
city: Greenwood Village
country: United States
facility: Endo Clinical Trial Site #23
state: Colorado
city: Boca Raton
country: United States
facility: Endo Clinical Trial Site #38
state: Florida
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #8
state: Florida
city: Largo
country: United States
facility: Endo Clinical Trial Site #40
state: Florida
city: Miami
country: United States
facility: Endo Clinical Trial Site #27
state: Florida
city: Miami
country: United States
facility: Endo Clinical Trial Site #36
state: Florida
city: Snellville
country: United States
facility: Endo Clinical Trial Site #20
state: Georgia
city: Meridian
country: United States
facility: Endo Clinical Trial Site #19
state: Idaho
city: Chicago
country: United States
facility: Endo Clinical Trial Site #34
state: Illinois
city: Indianapolis
country: United States
facility: Endo Clinical Trial Site #30
state: Indiana
city: Metairie
country: United States
facility: Endo Clinical Trial Site #16
state: Louisiana
city: New Orleans
country: United States
facility: Endo Clinical Trial Site #10
state: Louisiana
city: New Orleans
country: United States
facility: Endo Clinical Trial Site #25
state: Louisiana
city: Quincy
country: United States
facility: Endo Clinical Trial Site #33
state: Massachusetts
city: Washington
country: United States
facility: Endo Clinical Trial Site #18
state: Missouri
city: Omaha
country: United States
facility: Endo Clinical Trial Site #4
state: Nebraska
city: Mount Kisco
country: United States
facility: Endo Clinical Trial Site #24
state: New York
city: New York
country: United States
facility: Endo Clinical Trial Site #32
state: New York
city: New York
country: United States
facility: Endo Clinical Trial Site #12
state: New York
city: New York
country: United States
facility: Endo Clinical Trial Site #15
state: New York
city: New York
country: United States
facility: Endo Clinical Trial Site #29
state: New York
city: Cincinnati
country: United States
facility: Endo Clinical Trial Site #26
state: Ohio
city: Nashville
country: United States
facility: Endo Clinical Trial Site #5
state: Tennessee
city: Austin
country: United States
facility: Endo Clinical Trial Site #22
state: Texas
city: Beaumont
country: United States
facility: Endo Clinical Trial Site #6
state: Texas
city: Houston
country: United States
facility: Endo Clinical Trial Site #13
state: Texas
city: Houston
country: United States
facility: Endo Clinical Trial Site #7
state: Texas
city: Pflugerville
country: United States
facility: Endo Clinical Trial Site #28
state: Texas
city: San Antonio
country: United States
facility: Endo Clinical Trial Site #21
state: Texas
city: Sugar Land
country: United States
facility: Endo Clinical Trial Site #37
state: Texas
city: Salt Lake City
country: United States
facility: Endo Clinical Trial Site #31
state: Utah
city: Charlottesville
country: United States
facility: Endo Clinical Trial Site #1
state: Virginia
city: Lynchburg
country: United States
facility: Endo Clinical Trial Site #2
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Karen Chajko
role: STUDY_DIRECTOR
References: