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ACTIVE NOT RECRUITING

NCT06151197

PHASE3

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

Sponsor: Endo Pharmaceuticals

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

418

Start Date

2023-11-28

Completion Date

2026-03

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Plantar Fibromatosis Ledderhose Disease

Interventions

BIOLOGICAL

EN3835

Biologic: EN3835 injection

OTHER

Placebo

Placebo injection

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.

Locations (66)

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

Endo Site 53

Los Angeles, California, United States

Endo Site 50

San Francisco, California, United States

Endo Site 29

Sherman Oaks, California, United States

Endo Site 30

Tarzana, California, United States

Endo Site 61

Torrance, California, United States

Endo Site 47

Johnstown, Colorado, United States

Endo Site 65

Parker, Colorado, United States

Endo Site 17

Westminster, Colorado, United States

Endo Site 22

Hialeah, Florida, United States

Endo Site 59

Jacksonville, Florida, United States

Endo Site 23

Miami, Florida, United States

Endo Site 21

Miami, Florida, United States

Endo Site 35

North Miami Beach, Florida, United States

Endo Site 19

Palm Beach Gardens, Florida, United States

Endo Clinical Site 1

Pinellas Park, Florida, United States

Endo Site 14

Plantation, Florida, United States

Endo Site 26

South Miami, Florida, United States

Endo Site 60

Sweetwater, Florida, United States

Endo Site 33

Virginia Gardens, Florida, United States

Endo Site 24

Lawrenceville, Georgia, United States

Endo Site 27

O'Fallon, Illinois, United States

Endo Site 45

Oak Brook, Illinois, United States

Endo Site 54

Overland Park, Kansas, United States

Endo Site 56

Shreveport, Louisiana, United States

Endo Site 5

Pasadena, Maryland, United States

Endo Site 16

Grand Rapids, Michigan, United States

Endo Site 12

Jefferson City, Missouri, United States

Endo Site 51

Billings, Montana, United States

Endo Site 36

Missoula, Montana, United States

Endo Site 34

Oradell, New Jersey, United States

Endo Site 62

Vineland, New Jersey, United States

Endo Site 15

Durham, North Carolina, United States

Endo Site 20

Wilmington, North Carolina, United States

Endo Site 63

Oklahoma City, Oklahoma, United States

Endo Site 10

Altoona, Pennsylvania, United States

Endo Site 44

Malvern, Pennsylvania, United States

Endo Site 38

State College, Pennsylvania, United States

Endo Site 48

Arlington, Texas, United States

Endo Site 3

Bedford, Texas, United States

Endo Site 43

Burleson, Texas, United States

Endo Site 25

Dallas, Texas, United States

Endo Site32

Fort Worth, Texas, United States

Endo Site 7

Georgetown, Texas, United States

Endo Site 55

Houston, Texas, United States

Endo Site 40

Humble, Texas, United States

Endo Site 4

McAllen, Texas, United States

Endo Site 46

San Antonio, Texas, United States

Endo Site 18

San Antonio, Texas, United States

Endo Site 37

San Antonio, Texas, United States

Endo Site 41

Bountiful, Utah, United States

Endo Site 6

Salt Lake City, Utah, United States

Endo Site 52

Falls Church, Virginia, United States

Endo Site 13

Suffolk, Virginia, United States

Endo Site 68

Mayagüez, Puerto Rico

Endo Site 70

Mayagüez, Puerto Rico

Endo Site 69

Ponce, Puerto Rico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (66)