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

Endo Pharmaceuticals

Status and phase

Enrolling

Phase 3

Conditions

Ledderhose Disease

Plantar Fibromatosis

Treatments

Other: Placebo

Biological: EN3835

Study type

Interventional

Funder types

Industry

Identifiers

NCT06151197

EN3835-309

Details and patient eligibility

About

This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).

Enrollment

418 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 any medication to treat PFI pain, except as permitted per the protocol.
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.
Be capable of providing consent, are adequately informed, and understand the nature and 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, 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 foot and/or would impair his/her completion of study assessments as determined by the investigator.
Has any 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 or required assessments and evaluations.
Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
Has a clinically significant laboratory abnormality.
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, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not 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 manner during the study.