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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 483
- 试验地点
- 80
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to Day 1080
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.
Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment
时间窗: From Day 180 (Open-label Phase) up to Day 1080
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.
次要结局
- 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)
- 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)