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临床试验/NCT05254457
NCT05254457已完成3 期

A Multi-Center, Open-Label, Extension Study to Evaluate the Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis

Endo Pharmaceuticals27 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2022年2月14日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
145
试验地点
27
主要终点
Proportion of participants reporting adverse events (AE)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of EN3835 in the treatment and retreatment of plantar fibromatosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Have been enrolled and completed a sponsored-clinical study of EN3835 (for the EN3835-222 study, participants who completed the study are those that completed the Day 57 visit, were assessed for safety and received at least 1 dose of study intervention).
  • •Willing and able to comply with all protocol required visits and assessments.
  • •Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit.
  • •Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
  • •Willing and able to comply with all protocol required visits and assessments.
  • •Be adequately informed and understand the nature and risks of the study and be able to provide consent
  • •If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Day 1 Visit), or, if of childbearing potential, be nonpregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
  • •Have no significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.

排除标准

  • •Has any musculoskeletal, neuromuscular, neurosensory, or other neurological or related disorder that affects the participant's use of his or her feet and/or would impair his/her completion of study assessments as determined by the investigator.
  • •Any other significant medical condition or had an SAE in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
  • •Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated.
  • •Has a known systemic allergy to collagenase or any other excipient of EN
  • •Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study.
  • •Has significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
  • •Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except <150mg of aspirin daily, 7 days prior to first injection and for the duration of the study.

研究组 & 干预措施

Treated or Retreated Group

Experimental

干预措施: EN3835 (Biological)

结局指标

主要结局

Proportion of participants reporting adverse events (AE)

时间窗: Day 1 to Day 450

Proportion of participants reporting AE during the study assessed by incidence, severity and duration

次要结局

  • Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study(Observational Days 60, 120, 180, 270, 360, and 450)
  • Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study(Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237)
  • Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study(Days 180 or 270)
  • Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study(Treatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study(Observational Days 60, 120, 180, 270, 360, and 450)
  • Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study(Observational Days 60, 120, 180, 270, 360, and 450)
  • Change from baseline in the nodular consistency of the treated nodules by palpation in participants treated in the parent studies, and participants retreated in this study(Observational Days 60, 120, 180, 270, 360, and 450)
  • Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study(Observational Days 60, 120, 180, 270, 360, and 450)
  • Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study(Observational Days 60, 120, 180, 270, 360, and 450)
  • Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study(Observational Days 60, 120, 180, 270, 360, and 450)
  • Change from baseline (Retreatment) on the Foot Function Index (FFI) subscales (pain, difficulty, and activity limitation) in the parent studies, and participants retreated in this study(Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237)
  • Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study(Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study(Treatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study(Change from baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Change from baseline (Retreatment Day 1) in the nodular consistency of the treated nodules by palpation in the parent studies, and participants retreated in this study(Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study(Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study(Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Presence of neutralizing antibodies to AUX-I and AUX-II(Retreatment/ Treatment Day 57 and Day 450)
  • Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study(Change from Baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study(Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237)
  • Presence of anti-AUX-I and anti-AUX-II antibody titer levels(Retreatment/Treatment Day 57 and Day 450)
  • Change from baseline (Treatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study(Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237)

研究者

发起方
Endo Pharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (27)

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