Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women

Study Overview
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Brief Summary
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This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.

Official Title
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A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy

Conditions
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Edematous Fibrosclerotic Panniculopathy

Intervention / Treatment
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* Biological: Previously Treated with EN3835


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To qualify for the study a subject must: Be able to provide voluntary written informed consent prior to the initiation of any study-specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC). Have participated in and completed both studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201. Be willing and able to comply with all protocol required visits and assessments. Exclusion Criteria: Subjects will be ineligible for participation in this study if the subject: Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-202. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study. Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision). Any investigational treatment for EFP/cellulite. Endermologie® or similar treatments. Massage therapy. Creams (eg, Celluvera™, TriLastin®). Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br>Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in the EN3835-201 study, will be eligible for this study. The study will consist of up to two evaluations approximately 3 years after the first dose of study drug was received in the EN3835-201 study. | Biological: Previously Treated with EN3835<br>* No treatment to be administered - Observational only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) | Change from baseline (pre-dose, Day 1) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe | Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study | 
| Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) | Change from baseline (pre-dose, Day 1) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe | Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study | 
| Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) | Change from reference time point (Day 71) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe | Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study | 
| Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) | Change from reference time point (Day 71) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe | Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Edematous Fibrosclerotic Panniculopathy, EFP, Cellulite