Status:
RECRUITING
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Plantar Fibromatosis
Ledderhose Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT06151197
Start Date
November 28 2023
End Date
March 1 2026
Last Update
October 17 2025
Active Locations (70)
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1
Endo Site 42
Mesa, Arizona, United States, 85210
2
Endo Site 64
Scottsdale, Arizona, United States, 85260
3
Endo Site 11
Tucson, Arizona, United States, 85712
4
Endo Site 49
Castro Valley, California, United States, 94546