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

Endo Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cellulite; Edematous Fibrosclerotic Panniculopathy

Treatments: Biological: CCH-aaes; Other: Observation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03526549

EN3835-304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 483 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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483 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Observation

Biological: CCH-aaes

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

Other group

Description:

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.

Treatment:

Other: Observation