Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis

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Endo Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Plantar Fibromatosis

Treatments

Biological: EN3835

Study type

Interventional

Funder types

Industry

Identifiers

NCT05254457
EN3835-306

Details and patient eligibility

About

Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 and assess the efficacy and safety of EN3835 in the treatment and retreatment of Plantar Fibromatosis.

Enrollment

145 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 EN3835.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

145 participants in 2 patient groups

Observation Only Group
No Intervention group
Treated or Retreated Group
Experimental group
Treatment:
Biological: EN3835

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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