Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis

Endo Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Plantar Fibromatosis

Treatments

Other: Placebo

Biological: EN3835

Study type

Interventional

Funder types

Industry

Identifiers

NCT05152173

EN3835-222

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis.

Enrollment

177 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has a diagnosis of plantar fibromatosis AND have at least 1 measurable, hard or firm, palpable fibrous nodule on clinical examination.
Has no significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration.
Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening Visit.
Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
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 Screening Visit); or, if of childbearing potential, be non-pregnant, 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.
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.

Exclusion criteria

Has the presence of non-plantar fibromatosis-related nodules on the foot/feet (eg, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
Has any musculoskeletal, neuromuscular, neurosensory, 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.
Has a known allergy to collagenase or any other excipient of EN3835.
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.
Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being. If there is a history of such disease and the condition has been stable for greater than one year and is judged by the investigator not to interfere, the participant may be included, with the documented approval of the Medical Monitor.
Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
Has any other condition(s) that, in the investigator's opinion, might indicate the participants to be unsuitable for the study.