Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)

Key Inclusion Criteria:

• Be an ambulatory male or female ≥18 years of age.

• Have a diagnosis of PFI.

• Have current foot pain due to PFI.

• Agree not to use prohibited medication, throughout the study, and not use anymedication to treat PFI pain, except as permitted per the protocol.

• If female, be of non-childbearing potential (history of hysterectomy, bilateraloophorectomy, bilateral tubal ligation, or postmenopausal with no history ofmenstrual flow in the 12 months prior to the Screening Visit); or, if ofchildbearing potential, be non-pregnant, non-lactating and agree to use effectivecontraception when with a male partner for the duration of the study and for 28 daysafter any active treatment period.

• Be capable of providing consent, are adequately informed, and understand the natureand risks of the study.

Key Exclusion Criteria:

• Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma,rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, ormalignant soft tissue lesions of the foot or ankle).

• Has any musculoskeletal, neuromuscular, neurosensory, other neurological or relateddisorder that affects the participant's use of his or her foot and/or would impairhis/her completion of study assessments as determined by the investigator.

• Has any significant medical history or examination findings related to theparticipant's plantar nodule(s), which in the investigator's opinion, would make theparticipant unsuitable for study intervention administration or required assessmentsand evaluations.

• Has a known bleeding disorder which would make the participant unsuitable forenrollment in the study.

• Has a clinically significant laboratory abnormality.

• Has concurrent diseases that might interfere with the conduct of the study, confoundthe interpretation of the study results or endanger the participant's well-being, orany significant hematological, endocrine, cardiovascular, respiratory, renal,hepatic, or gastrointestinal disease. If there is a history of such disease but thecondition has been stable for greater than 1 year and is judged by the investigatornot to interfere with participation in the study, the participant may be included,with the documented approval of the medical monitor.

• Has any other significant medical condition(s), which in the investigator's opinion,would make the participant unsuitable for enrollment in the study.

• Is pregnant or plans to become pregnant.

• Is breastfeeding or is providing or plans to provide breast milk in any mannerduring the study.