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

NCT06151197 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: EN3835-309
• Study Type: interventional
• Target: 418
• Locations: 2 countries
• Sites: 66

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).

Conditions

Ledderhose Disease; Plantar Fibromatosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

EN3835

EXPERIMENTAL

Biological: EN3835

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

EN3835 BIOLOGICAL

Biologic: EN3835 injection

EN3835

Placebo OTHER

Placebo injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (66)

Endo Site 42

Mesa, Arizona, 85210, United States

Location

Endo Site 64

Scottsdale, Arizona, 85260, United States

Location

Endo Site 11

Tucson, Arizona, 85712, United States

Location

Endo Site 49

Castro Valley, California, 94546, United States

Location

Endo Site 39

Cerritos, California, 90703, United States

Location

Endo Site 31

Corona, California, 92882, United States

Location

Endo Clinical Site 2

Encinitas, California, 92024, United States

Location

Endo Site 8

Fresno, California, 93710, United States

Location

Endo Site 28

Lancaster, California, 93534, United States

Location

Endo Site 9

Los Angeles, California, 90010, United States

Location

Endo Site 53

Los Angeles, California, 90063, United States

Location

Endo Site 50

San Francisco, California, 94115, United States

Location

Endo Site 29

Sherman Oaks, California, 91403, United States

Location

Endo Site 30

Tarzana, California, 91356, United States

Location

Endo Site 61

Torrance, California, 90502, United States

Location

Endo Site 47

Johnstown, Colorado, 80535, United States

Location

Endo Site 65

Parker, Colorado, 80134, United States

Location

Endo Site 17

Westminster, Colorado, 80031, United States

Location

Endo Site 22

Hialeah, Florida, 33013, United States

Location

Endo Site 59

Jacksonville, Florida, 32209, United States

Location

Endo Site 23

Miami, Florida, 33126, United States

Location

Endo Site 21

Miami, Florida, 33165, United States

Location

Endo Site 35

North Miami Beach, Florida, 33169, United States

Location

Endo Site 19

Palm Beach Gardens, Florida, 33410, United States

Location

Endo Clinical Site 1

Pinellas Park, Florida, 33782, United States

Location

Endo Site 14

Plantation, Florida, 33317, United States

Location

Endo Site 26

South Miami, Florida, 33143, United States

Location

Endo Site 60

Sweetwater, Florida, 33172, United States

Location

Endo Site 33

Virginia Gardens, Florida, 33166, United States

Location

Endo Site 24

Lawrenceville, Georgia, 30043, United States

Location

Endo Site 27

O'Fallon, Illinois, 62269, United States

Location

Endo Site 45

Oak Brook, Illinois, 60523, United States

Location

Endo Site 54

Overland Park, Kansas, 66211, United States

Location

Endo Site 56

Shreveport, Louisiana, 71101, United States

Location

Endo Site 5

Pasadena, Maryland, 21122, United States

Location

Endo Site 16

Grand Rapids, Michigan, 49525, United States

Location

Endo Site 12

Jefferson City, Missouri, 65109, United States

Location

Endo Site 51

Billings, Montana, 59101, United States

Location

Endo Site 36

Missoula, Montana, 59804, United States

Location

Endo Site 34

Oradell, New Jersey, 07649, United States

Location

Endo Site 62

Vineland, New Jersey, 08360, United States

Location

Endo Site 15

Durham, North Carolina, 27704, United States

Location

Endo Site 20

Wilmington, North Carolina, 28412, United States

Location

Endo Site 63

Oklahoma City, Oklahoma, 73139, United States

Location

Endo Site 10

Altoona, Pennsylvania, 16602, United States

Location

Endo Site 44

Malvern, Pennsylvania, 19355, United States

Location

Endo Site 38

State College, Pennsylvania, 16801, United States

Location

Endo Site 48

Arlington, Texas, 76015, United States

Location

Endo Site 3

Bedford, Texas, 76021, United States

Location

Endo Site 43

Burleson, Texas, 76028, United States

Location

Endo Site 25

Dallas, Texas, 75208, United States

Location

Endo Site32

Fort Worth, Texas, 76104, United States

Location

Endo Site 7

Georgetown, Texas, 78628, United States

Location

Endo Site 55

Houston, Texas, 77027, United States

Location

Endo Site 40

Humble, Texas, 77338, United States

Location

Endo Site 4

McAllen, Texas, 78501, United States

Location

Endo Site 46

San Antonio, Texas, 78224, United States

Location

Endo Site 18

San Antonio, Texas, 78251, United States

Location

Endo Site 37

San Antonio, Texas, 78258, United States

Location

Endo Site 41

Bountiful, Utah, 84010, United States

Location

Endo Site 6

Salt Lake City, Utah, 84107, United States

Location

Endo Site 52

Falls Church, Virginia, 22042, United States

Location

Endo Site 13

Suffolk, Virginia, 23434, United States

Location

Endo Site 68

Mayagüez, 00680, Puerto Rico

Location

Endo Site 70

Mayagüez, 00680, Puerto Rico

Location

Endo Site 69

Ponce, 00716, Puerto Rico

Location

MeSH Terms

Conditions

Fibromatosis, Plantar

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Foot Diseases; Musculoskeletal Diseases; Contracture; Muscular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Louis Ortega

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: November 28, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (63); PR (3)