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

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ledderhose Disease; Plantar Fibromatosis
• Intervention / Treatment: Other: Placebo; Biological: EN3835

• Study Type: Interventional
• Enrollment (Estimated): 418
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Mayagüez, Puerto Rico, 00680
    • Endo Site 68
  • Mayagüez, Puerto Rico, 00680
    • Endo Site 70
  • Ponce, Puerto Rico, 00716
    • Endo Site 69
• United States
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Endo Site 42
    • Scottsdale, Arizona, United States, 85260
      • Endo Site 64
    • Tucson, Arizona, United States, 85712
      • Endo Site 11
  • California
    • Castro Valley, California, United States, 94546
      • Endo Site 49
    • Cerritos, California, United States, 90703
      • Endo Site 39
    • Corona, California, United States, 92882
      • Endo Site 31
    • Encinitas, California, United States, 92024
      • Endo Clinical Site 2
    • Fresno, California, United States, 93710
      • Endo Site 8
    • Lancaster, California, United States, 93534
      • Endo Site 28
    • Los Angeles, California, United States, 90010
      • Endo Site 9
    • Los Angeles, California, United States, 90063
      • Endo Site 53
    • San Francisco, California, United States, 94115
      • Endo Site 50
    • Sherman Oaks, California, United States, 91403
      • Endo Site 29
    • Tarzana, California, United States, 91356
      • Endo Site 30
    • Torrance, California, United States, 90502
      • Endo Site 61
  • Colorado
    • Johnstown, Colorado, United States, 80535
      • Endo Site 47
    • Parker, Colorado, United States, 80134
      • Endo Site 65
    • Westminster, Colorado, United States, 80031
      • Endo Site 17
  • Florida
    • Hialeah, Florida, United States, 33013
      • Endo Site 22
    • Jacksonville, Florida, United States, 32209
      • Endo Site 59
    • Miami, Florida, United States, 33126
      • Endo Site 23
    • Miami, Florida, United States, 33165
      • Endo Site 21
    • North Miami Beach, Florida, United States, 33169
      • Endo Site 35
    • Palm Beach Gardens, Florida, United States, 33410
      • Endo Site 19
    • Pinellas Park, Florida, United States, 33782
      • Endo Clinical Site 1
    • Plantation, Florida, United States, 33317
      • Endo Site 14
    • South Miami, Florida, United States, 33143
      • Endo Site 26
    • Sweetwater, Florida, United States, 33172
      • Endo Site 60
    • Virginia Gardens, Florida, United States, 33166
      • Endo Site 33
  • Georgia
    • Lawrenceville, Georgia, United States, 30043
      • Endo Site 24
  • Illinois
    • O'Fallon, Illinois, United States, 62269
      • Endo Site 27
    • Oak Brook, Illinois, United States, 60523
      • Endo Site 45
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Endo Site 54
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Endo Site 56
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Endo Site 5
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Endo Site 16
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Endo Site 12
  • Montana
    • Billings, Montana, United States, 59101
      • Endo Site 51
    • Missoula, Montana, United States, 59804
      • Endo Site 36
  • New Jersey
    • Oradell, New Jersey, United States, 07649
      • Endo Site 34
    • Vineland, New Jersey, United States, 08360
      • Endo Site 62
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Endo Site 15
    • Wilmington, North Carolina, United States, 28412
      • Endo Site 20
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73139
      • Endo Site 63
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Endo Site 10
    • Malvern, Pennsylvania, United States, 19355
      • Endo Site 44
    • State College, Pennsylvania, United States, 16801
      • Endo Site 38
  • Texas
    • Arlington, Texas, United States, 76015
      • Endo Site 48
    • Bedford, Texas, United States, 76021
      • Endo Site 3
    • Burleson, Texas, United States, 76028
      • Endo Site 43
    • Dallas, Texas, United States, 75208
      • Endo Site 25
    • Fort Worth, Texas, United States, 76104
      • Endo Site32
    • Georgetown, Texas, United States, 78628
      • Endo Site 7
    • Houston, Texas, United States, 77027
      • Endo Site 55
    • Humble, Texas, United States, 77338
      • Endo Site 40
    • McAllen, Texas, United States, 78501
      • Endo Site 4
    • San Antonio, Texas, United States, 78224
      • Endo Site 46
    • San Antonio, Texas, United States, 78251
      • Endo Site 18
    • San Antonio, Texas, United States, 78258
      • Endo Site 37
  • Utah
    • Bountiful, Utah, United States, 84010
      • Endo Site 41
    • Salt Lake City, Utah, United States, 84107
      • Endo Site 6
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Endo Site 52
    • Suffolk, Virginia, United States, 23434
      • Endo Site 13

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo injection
Experimental: EN3835	Biological: EN3835; Biologic: EN3835 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Change from Baseline in the FFI Total 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

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Investigators: Study Director: Louis Ortega, Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Skin Diseases; Foot Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Skin and Connective Tissue Diseases; Fibromatosis, Plantar; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: EN3835-309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No