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

NCT03526549 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EN3835-304
• Study Type: interventional
• Target: 483
• Locations: 1 country
• Sites: 42

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.

Conditions

Edematous Fibrosclerotic Panniculopathy; Cellulite

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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

• Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS

  From Day 180 (Open-label Observation Phase) up to Day 1080

• Time to Complete Loss of Response in CR-PCSS and PR-PCSS

  From Day 180 (Open-label Observation Phase) up to Day 1080

Study Arms (2)

CCH-aaes Treatment in Parent Studies (EN3835-302/303)

EXPERIMENTAL

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.

Biological: CCH-aaes; Other: Observation

Placebo Treatment in Parent Studies (EN3835-302/303)

OTHER

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.

Other: Observation

Interventions

CCH-aaes BIOLOGICAL

Administered to participants who qualified for, and opted for, retreatment.

Also known as: EN3835, QWO™

CCH-aaes Treatment in Parent Studies (EN3835-302/303)

Observation OTHER

No treatment administered during 180 days of observation.

CCH-aaes Treatment in Parent Studies (EN3835-302/303); Placebo Treatment in Parent Studies (EN3835-302/303)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants (Through Day 180):
• Voluntarily sign and date an informed consent agreement
• Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303
• Be willing to apply sunscreen to the buttocks before each exposure to the sun and/or tanning booths while participating in the study
• Be judged to be in good health
• Be willing and able to cooperate with the requirements of the study
• Be able to read, complete and understand the participant reported outcomes rating instruments in English.
• \. Have a negative pregnancy test and using a stable and effective contraception method.

You may not qualify if:

• All Participants (Through Day 180):
• Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
• Intends to use tanning spray or tanning booths during this period
• Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
• Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for the study
• \. Has received any collagenase treatments at any time since completion of the double-blind study (EN3835-302 or EN3835-303).
• \. 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (42)

Endo Clinical Trial Site #3

Glendale, Arizona, 85308, United States

Location

Endo Clinical Trial Site #11

Scottsdale, Arizona, 85258, United States

Location

Endo Clinical Trial Site #41

North Little Rock, Arkansas, 72116, United States

Location

Endo Clinical Trial Site #14

Encinitas, California, 92024, United States

Location

Endo Clinical Trial Site #9

Long Beach, California, 90806, United States

Location

Endo Clinical Trial Site #35

Murrieta, California, 92562, United States

Location

Endo Clinical Trial Site #42

Newport Beach, California, 92663, United States

Location

Endo Clinical Trial Site #17

Oceanside, California, 92056, United States

Location

Endo Clinical Trial Site #39

San Diego, California, 92121, United States

Location

Endo Clinical Trial Site #23

Greenwood Village, Colorado, 80111, United States

Location

Endo Clinical Trial Site #38

Boca Raton, Florida, 33486, United States

Location

Endo Clinical Trial Site #8

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #40

Largo, Florida, 33770, United States

Location

Endo Clinical Trial Site #27

Miami, Florida, 33137, United States

Location

Endo Clinical Trial Site #36

Miami, Florida, 33185, United States

Location

Endo Clinical Trial Site #20

Snellville, Georgia, 30078, United States

Location

Endo Clinical Trial Site #19

Meridian, Idaho, 83642, United States

Location

Endo Clinical Trial Site #34

Chicago, Illinois, 60654, United States

Location

Endo Clinical Trial Site #30

Indianapolis, Indiana, 46260, United States

Location

Endo Clinical Trial Site #16

Metairie, Louisiana, 70006, United States

Location

Endo Clinical Trial Site #10

New Orleans, Louisiana, 70115, United States

Location

Endo Clinical Trial Site #25

New Orleans, Louisiana, 70124, United States

Location

Endo Clinical Trial Site #33

Quincy, Massachusetts, 02169, United States

Location

Endo Clinical Trial Site #18

Washington, Missouri, 63090, United States

Location

Endo Clinical Trial Site #4

Omaha, Nebraska, 68144, United States

Location

Endo Clinical Trial Site #24

Mount Kisco, New York, 10549, United States

Location

Endo Clinical Trial Site #32

New York, New York, 10016, United States

Location

Endo Clinical Trial Site #12

New York, New York, 10022, United States

Location

Endo Clinical Trial Site #15

New York, New York, 10065, United States

Location

Endo Clinical Trial Site #29

New York, New York, 10075, United States

Location

Endo Clinical Trial Site #26

Cincinnati, Ohio, 45236, United States

Location

Endo Clinical Trial Site #5

Nashville, Tennessee, 37215, United States

Location

Endo Clinical Trial Site #22

Austin, Texas, 78759, United States

Location

Endo Clinical Trial Site #6

Beaumont, Texas, 77701, United States

Location

Endo Clinical Trial Site #13

Houston, Texas, 77056, United States

Location

Endo Clinical Trial Site #7

Houston, Texas, 77494, United States

Location

Endo Clinical Trial Site #28

Pflugerville, Texas, 78660, United States

Location

Endo Clinical Trial Site #21

San Antonio, Texas, 78229, United States

Location

Endo Clinical Trial Site #37

Sugar Land, Texas, 77497, United States

Location

Endo Clinical Trial Site #31

Salt Lake City, Utah, 84101, United States

Location

Endo Clinical Trial Site #1

Charlottesville, Virginia, 22911, United States

Location

Endo Clinical Trial Site #2

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Cellulite

Interventions

Observation

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Results Point of Contact

• Title: Clinical Operations
• Organization: Endo Pharmaceuticals

ClinicalTrials@Endo.com

1-800-462-3636

Study Officials

• Karen Chajko

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Investigators, participants, and site personnel were blinded to the treatment administered in the EN3835-302/303 parent studies until all Day 180 visit assessments were completed. CCH-aaes retreatment in this study was provided in an open-label manner.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 16, 2018
• Study Start: April 26, 2018
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-08

Locations

US (42)