Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)

Cellulite Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526549
• Other study ID #: EN3835-304
• Status: Completed
• Phase: Phase 3
• Start date: April 26, 2018
• Est. completion date: October 8, 2021

Study information

• Verified date: August 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cellulite
• Edema
• Edematous Fibrosclerotic Panniculopathy

Intervention

Biological:
• CCH-aaes
Administered to participants who qualified for, and opted for, retreatment.

Other:
• Observation
No treatment administered during 180 days of observation.

Locations

Country	Name	City	State
United States	Endo Clinical Trial Site #22	Austin	Texas
United States	Endo Clinical Trial Site #6	Beaumont	Texas
United States	Endo Clinical Trial Site #38	Boca Raton	Florida
United States	Endo Clinical Trial Site #1	Charlottesville	Virginia
United States	Endo Clinical Trial Site #34	Chicago	Illinois
United States	Endo Clinical Trial Site #26	Cincinnati	Ohio
United States	Endo Clinical Trial Site #8	Coral Gables	Florida
United States	Endo Clinical Trial Site #14	Encinitas	California
United States	Endo Clinical Trial Site #3	Glendale	Arizona
United States	Endo Clinical Trial Site #23	Greenwood Village	Colorado
United States	Endo Clinical Trial Site #13	Houston	Texas
United States	Endo Clinical Trial Site #7	Houston	Texas
United States	Endo Clinical Trial Site #30	Indianapolis	Indiana
United States	Endo Clinical Trial Site #40	Largo	Florida
United States	Endo Clinical Trial Site #9	Long Beach	California
United States	Endo Clinical Trial Site #2	Lynchburg	Virginia
United States	Endo Clinical Trial Site #19	Meridian	Idaho
United States	Endo Clinical Trial Site #16	Metairie	Louisiana
United States	Endo Clinical Trial Site #27	Miami	Florida
United States	Endo Clinical Trial Site #36	Miami	Florida
United States	Endo Clinical Trial Site #24	Mount Kisco	New York
United States	Endo Clinical Trial Site #35	Murrieta	California
United States	Endo Clinical Trial Site #5	Nashville	Tennessee
United States	Endo Clinical Trial Site #10	New Orleans	Louisiana
United States	Endo Clinical Trial Site #25	New Orleans	Louisiana
United States	Endo Clinical Trial Site #12	New York	New York
United States	Endo Clinical Trial Site #15	New York	New York
United States	Endo Clinical Trial Site #29	New York	New York
United States	Endo Clinical Trial Site #32	New York	New York
United States	Endo Clinical Trial Site #42	Newport Beach	California
United States	Endo Clinical Trial Site #41	North Little Rock	Arkansas
United States	Endo Clinical Trial Site #17	Oceanside	California
United States	Endo Clinical Trial Site #4	Omaha	Nebraska
United States	Endo Clinical Trial Site #28	Pflugerville	Texas
United States	Endo Clinical Trial Site #33	Quincy	Massachusetts
United States	Endo Clinical Trial Site #31	Salt Lake City	Utah
United States	Endo Clinical Trial Site #21	San Antonio	Texas
United States	Endo Clinical Trial Site #39	San Diego	California
United States	Endo Clinical Trial Site #11	Scottsdale	Arizona
United States	Endo Clinical Trial Site #20	Snellville	Georgia
United States	Endo Clinical Trial Site #37	Sugar Land	Texas
United States	Endo Clinical Trial Site #18	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Day 1080
Primary	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.	From Day 180 (Open-label Phase) up to Day 1080
Secondary	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.	From Day 180 (Open-label Observation Phase) up to Day 1080
Secondary	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.	From Day 180 (Open-label Observation Phase) up to Day 1080
Secondary	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.	From Day 180 (Open-label Observation Phase) up to Day 1080