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Assessing EN3835 for treating plantar fibromatosis

A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)

Phase 3 Interventional Endo Pharmaceuticals · NCT06151197

This study is testing if a new treatment called EN3835 can help adults with plantar fibromatosis feel less foot pain compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment418 (estimated)
Ages18 Years and up
SexAll
SponsorEndo Pharmaceuticals Industry-sponsored
Locations70 sites (Mesa, Arizona and 69 other locations)
Trial IDNCT06151197 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of EN3835 in patients with plantar fibromatosis, also known as Ledderhose disease. Participants will be randomly assigned to receive either EN3835 or a placebo while monitoring their foot pain and overall condition. The study aims to determine if EN3835 can provide significant relief compared to no treatment. The trial is designed for adults who are experiencing pain due to this condition.

Who should consider this trial

Good fit: Ideal candidates are ambulatory adults aged 18 and older with a confirmed diagnosis of plantar fibromatosis and current foot pain.

Not a fit: Patients with non-PFI-related nodules on the foot or those unable to comply with the study's medication restrictions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate foot pain for patients suffering from plantar fibromatosis.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating fibromatosis with targeted therapies.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Mesa, Arizona and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plantar FibromatosisLedderhose Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.