Clinical trial NCT06151197: Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plantar Fibromatosis
Ledderhose Disease
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-11-30
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score
timeFrame: Baseline, up to Day 85
measure: Change from Baseline in the FFI Activity Limitation Subscale Score
timeFrame: Baseline, up to Day 85
measure: Change from Baseline in the FFI Pain Subscale Score
timeFrame: Baseline, up to Day 85
measure: Change from Baseline in the FFI Total Score
timeFrame: Baseline, up to Day 85
measure: Number of Participants That Used Rescue Analgesic Medication
timeFrame: Up to Day 85
measure: Amount of (milligrams [mg]) Rescue Analgesic Medication Used
timeFrame: Up to Day 85
measure: Patient Global Impression of Change (PGIC) Foot Pain Score
timeFrame: Up to Day 85
measure: Clinician Global Impression of Change (CGIC) Score
timeFrame: Up to Day 85
measure: Subject Satisfaction Score
timeFrame: Up to Day 85
measure: Change from Baseline in Nodule Consistency (Firmness)
timeFrame: Baseline, up to Day 85
measure: Change from Baseline in the Nodular Hardness of the Treated Nodules
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Endo Site 42
state: Arizona
city: Scottsdale
country: United States
facility: Endo Site 64
state: Arizona
city: Tucson
country: United States
facility: Endo Site 11
state: Arizona
city: Castro Valley
country: United States
facility: Endo Site 49
state: California
city: Cerritos
country: United States
facility: Endo Site 39
state: California
city: Corona
country: United States
facility: Endo Site 31
state: California
city: Encinitas
country: United States
facility: Endo Clinical Site 2
state: California
city: Fresno
country: United States
facility: Endo Site 8
state: California
city: Lancaster
country: United States
facility: Endo Site 28
state: California
city: Los Angeles
country: United States
facility: Endo Site 9
state: California
city: Los Angeles
country: United States
facility: Endo Site 53
state: California
city: San Francisco
country: United States
facility: Endo Site 50
state: California
city: Tarzana
country: United States
facility: Endo Site 29
state: California
city: Tarzana
country: United States
facility: Endo Site 30
state: California
city: Torrance
country: United States
facility: Endo Site 61
state: California
city: Johnstown
country: United States
facility: Endo Site 47
state: Colorado
city: Parker
country: United States
facility: Endo Site 65
state: Colorado
city: Westminster
country: United States
facility: Endo Site 17
state: Colorado
city: Washington
country: United States
facility: Endo Site 52
state: District of Columbia
city: Hialeah
country: United States
facility: Endo Site 22
state: Florida
city: Jacksonville
country: United States
facility: Endo Site 59
state: Florida
city: Jupiter
country: United States
facility: Endo Site 19
state: Florida
city: Medley
country: United States
facility: Endo Site 33
state: Florida
city: Miami
country: United States
facility: Endo Site 23
state: Florida
city: Miami
country: United States
facility: Endo Site 21
state: Florida
city: North Miami Beach
country: United States
facility: Endo Site 35
state: Florida
city: Pinellas Park
country: United States
facility: Endo Clinical Site 1
state: Florida
city: Plantation
country: United States
facility: Endo Site 14
state: Florida
city: South Miami
country: United States
facility: Endo Site 26
state: Florida
city: Sweetwater
country: United States
facility: Endo Site 60
state: Florida
city: Lawrenceville
country: United States
facility: Endo Site 24
state: Georgia
city: O'Fallon
country: United States
facility: Endo Site 27
state: Illinois
city: Oak Brook
country: United States
facility: Endo Site 45
state: Illinois
city: Overland Park
country: United States
facility: Endo Site 54
state: Kansas
city: Shreveport
country: United States
facility: Endo Site 56
state: Louisiana
city: Pasadena
country: United States
facility: Endo Site 5
state: Maryland
city: Grand Rapids
country: United States
facility: Endo Site 16
state: Michigan
city: Jefferson City
country: United States
facility: Endo Site 12
state: Missouri
city: Billings
country: United States
facility: Endo Site 51
state: Montana
city: Missoula
country: United States
facility: Endo Site 36
state: Montana
city: Vineland
country: United States
facility: Endo Site 62
state: New Jersey
city: Westwood
country: United States
facility: Endo Site 34
state: New Jersey
city: Durham
country: United States
facility: Endo Site 15
state: North Carolina
city: Wilmington
country: United States
facility: Endo Site 20
state: North Carolina
city: Oklahoma City
country: United States
facility: Endo Site 63
state: Oklahoma
city: Altoona
country: United States
facility: Endo Site 10
state: Pennsylvania
city: Malvern
country: United States
facility: Endo Site 44
state: Pennsylvania
city: State College
country: United States
facility: Endo Site 38
state: Pennsylvania
city: Arlington
country: United States
facility: Endo Site 48
state: Texas
city: Bedford
country: United States
facility: Endo Site 3
state: Texas
city: Burleson
country: United States
facility: Endo Site 43
state: Texas
city: Dallas
country: United States
facility: Endo Site 25
state: Texas
city: Fort Worth
country: United States
facility: Endo Site32
state: Texas
city: Georgetown
country: United States
facility: Endo Site 7
state: Texas
city: Houston
country: United States
facility: Endo Site 55
state: Texas
city: Humble
country: United States
facility: Endo Site 40
state: Texas
city: McAllen
country: United States
facility: Endo Site 4
state: Texas
city: San Antonio
country: United States
facility: Endo Site 46
state: Texas
city: San Antonio
country: United States
facility: Endo Site 18
state: Texas
city: San Antonio
country: United States
facility: Endo Site 37
state: Texas
city: Bountiful
country: United States
facility: Endo Site 41
state: Utah
city: Salt Lake City
country: United States
facility: Endo Site 6
state: Utah
city: Suffolk
country: United States
facility: Endo Site 13
state: Virginia
city: East Maitland
country: Australia
facility: Endo Site 58
state: New South Wales
city: Hunter
country: Australia
facility: Endo Site 57
state: New South Wales
city: Auchenflower
country: Australia
facility: Endo Site 67
state: Queensland
city: Victoria Park
country: Australia
facility: Endo Site 66
state: Western Australia
city: Mayagüez
country: Puerto Rico
facility: Endo Site 68
city: Mayagüez
country: Puerto Rico
facility: Endo Site 70
city: Ponce
country: Puerto Rico
facility: Endo Site 69
Study officials:
affiliation: Endo Pharmaceuticals
name: Luis Ortega
role: STUDY_DIRECTOR
References: