Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
NCT ID: NCT06151197
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
418 participants
INTERVENTIONAL
2023-11-28
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EN3835
EN3835
Biologic: EN3835 injection
Placebo
Placebo
Placebo injection
Interventions
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EN3835
Biologic: EN3835 injection
Placebo
Placebo injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Luis Ortega
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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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
Tarzana, 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 33
Medley, 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 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 58
East Maitland, New South Wales, Australia
Endo Site 57
Hunter, New South Wales, Australia
Endo Site 67
Auchenflower, Queensland, Australia
Endo Site 66
Victoria Park, Western Australia, Australia
Endo Site 68
Mayagüez, , Puerto Rico
Endo Site 70
Mayagüez, , Puerto Rico
Endo Site 69
Ponce, , Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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EN3835-309
Identifier Type: -
Identifier Source: org_study_id
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