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

Phase 3

Recruiting

• Conditions: Plantar Fibromatosis; Ledderhose Disease
• Interventions: Other: Placebo; Biological: EN3835

• Registration Number: NCT06151197
• Lead Sponsor: Endo Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study Start: 2023-11-28
• Study First Posted: 2023-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 418

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
EN3835	EN3835	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS)	Baseline, Week 12

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in the FFI Total Score	Baseline, up to Day 85
Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score	Baseline, up to Day 85
Change from Baseline in the FFI Activity Limitation Subscale Score	Baseline, up to Day 85
Change from Baseline in the FFI Pain Subscale Score	Baseline, up to Day 85
Number of Participants That Used Rescue Analgesic Medication	Up to Day 85
Amount of (milligrams [mg]) Rescue Analgesic Medication Used	Up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Score	Up to Day 85
Clinician Global Impression of Change (CGIC) Score	Up to Day 85
Subject Satisfaction Score	Up to Day 85
Change from Baseline in Nodule Consistency (Firmness)	Baseline, up to Day 85
Change from Baseline in the Nodular Hardness of the Treated Nodules	Up to Day 85

Trial Locations

Locations (70)

Endo Site 42; 🇺🇸 Mesa, Arizona, United States

Endo Site 64; 🇺🇸 Scottsdale, Arizona, United States

Endo Site 11; 🇺🇸 Tucson, Arizona, United States

Endo Site 49; 🇺🇸 Castro Valley, California, United States

Endo Site 39; 🇺🇸 Cerritos, California, United States

Endo Site 31; 🇺🇸 Corona, California, United States

Endo Clinical Site 2; 🇺🇸 Encinitas, California, United States

Endo Site 8; 🇺🇸 Fresno, California, United States

Endo Site 28; 🇺🇸 Lancaster, California, United States

Endo Site 9; 🇺🇸 Los Angeles, California, United States

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