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

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.