Phase 3
N=483
Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
Edematous Fibrosclerotic Panniculopathy · Cellulite
Bottom Line
View on ClinicalTrials.gov: NCT03526549 ↗Enrolled (actual)
483
Serious AEs
1.1%
Results posted
Sep 2023
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 58; 29; 43; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CCH-aaes (Biological); Observation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
58; 29; 43; 45 | — |
| PRIMARY Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment |
98.2; 100 | — |
| 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) |
NA | — |
| SECONDARY Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS |
356.5 | — |
| SECONDARY Time to Complete Loss of Response in CR-PCSS and PR-PCSS |
238.2 | — |
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.
Eligibility Criteria
Key Inclusion Criteria
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.
Key Inclusion Criteria for Participants Eligible for Retreatment:
- Have a negative pregnancy test and using a stable and effective contraception method.
Key Exclusion Criteria
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
Additional Exclusion Criteria may apply Post Day 180:
- 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:
- 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
Data sourced from ClinicalTrials.gov (NCT03526549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.