A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)

Study Overview
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Brief Summary
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This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.

Official Title
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A Phase 2, Double-blind, Randomized, Placebo-controlled, Dose-ranging Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fasciitis (PFA)

Conditions
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Plantar Fasciitis

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: Have no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration. Have a diagnosis of plantar fasciitis for ≥6 months, which has not responded to conservative therapies. Conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs). Have current foot pain due to plantar fasciitis. Key Exclusion Criteria: Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain. Has a clinically meaningful laboratory abnormality. Has a body mass index ≥35 kilograms per meter squared (kg/m^2). Has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Group 1: EN3835<br>Participants will receive EN3835 Dose 1. | Biological: EN3835<br>* Biologic: Intrafascial injection<br>|
| Experimental: Group 2: EN3835<br>Participants will receive EN3835 Dose 2. | Biological: EN3835<br>* Biologic: Intrafascial injection<br>|
| Placebo Comparator: Group 3: Placebo<br>Participants will receive matching placebo. | Other: Placebo<br>* Intrafascial injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline at 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 up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score |  | Baseline, up to Day 85 | 
| Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score |  | Baseline, up to Day 85 | 
| Change from Baseline up to Week 12 in the Weekly Mean of the ADP Score as Measured on the Pain Intensity NRS |  | Baseline, up to Week 12 | 
| Change from Baseline up to Day 85 in the FFI Pain Subscale Score |  | Baseline, up to Day 85 | 
| Change from Baseline up to Day 85 in the FFI Total Score |  | Baseline, up to Day 85 | 
| Number of Participants That Used Rescue Analgesic Medication |  | Up to Day 85 | 
| Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used |  | Up to Day 85 | 
| Patient Global Impression of Change (PGIC) Foot Pain Scale Score |  | Up to Day 85 | 
| Clinician Global Impression of Change (CGIC) Scale Score |  | Up to Day 85 | 
| Subject Satisfaction with Treatment Scale Score |  | Up to Day 85 |