Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar … (NCT05254457) | Clinical Trial Compass
CompletedPhase 3
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
United States145 participantsStarted 2022-02-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Proportion of participants reporting adverse events (AE)
✕. 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.