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

Study Overview
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Brief Summary
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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
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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)

Conditions
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Plantar Fibromatosis, Ledderhose Disease

Intervention / Treatment
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* Biological: EN3835
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EN3835<br> | Biological: EN3835<br>* Biologic: EN3835 injection<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |