A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA)

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)

This study will assess the efficacy, safety, and tolerability of 2 different doses of collagenase clostridium histolyticum (CCH) (previously known as EN3835) compared to placebo.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Biological: Collagenase Clostridium Histolyticum (CCH); Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Endo Site 8
  • California
    • Castro Valley, California, United States, 94546
      • Endo Site 20
    • Corona, California, United States, 92882
      • Endo Site 13
    • Encinitas, California, United States, 92024
      • Endo Site 6
    • Fresno, California, United States, 93710
      • Endo Site 11
    • Los Angeles, California, United States, 90010
      • Endo Site 16
    • Los Angeles, California, United States, 90063
      • Endo Site 40
    • San Francisco, California, United States, 94115
      • Endo Site 21
    • Tarzana, California, United States, 91356
      • Endo Site 10
  • Florida
    • Coconut Creek, Florida, United States, 33073
      • Endo Site 37
    • Pinellas Park, Florida, United States, 33782
      • Endo Clinical Site 3
    • Sweetwater, Florida, United States, 33172
      • Endo Site 14
  • Georgia
    • Lawrenceville, Georgia, United States, 30043
      • Endo Site 7
    • Stonecrest, Georgia, United States, 30038
      • Endo Site 23
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Endo Site 31
    • O'Fallon, Illinois, United States, 62269
      • Endo Site 28
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Endo Site 33
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Endo Site 35
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Endo Clinical Site 2
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Endo Site 19
  • Montana
    • Missoula, Montana, United States, 59804
      • Endo Site 27
  • New Jersey
    • Westwood, New Jersey, United States, 07675
      • Endo Site 38
  • Oklahoma
    • Moore, Oklahoma, United States, 73160
      • Endo Site 25
  • Oregon
    • Portland, Oregon, United States, 97202
      • Endo Site 39
  • Pennsylvania
    • Malvern, Pennsylvania, United States, 19355
      • Endo Site 36
  • Texas
    • Bedford, Texas, United States, 76021
      • Endo Clinical Site 4
    • Burleson, Texas, United States, 76028
      • Endo Site 24
    • Dallas, Texas, United States, 75208
      • Endo Site 17
    • Dallas, Texas, United States, 75235
      • Endo Site 26
    • Dallas, Texas, United States, 75251
      • Endo Site 18
    • Fort Worth, Texas, United States, 76104
      • Endo Site 30
    • Georgetown, Texas, United States, 78628
      • Endo Clinical Site 1
    • Houston, Texas, United States, 77027
      • Endo Site 15
    • McAllen, Texas, United States, 78501
      • Endo Site 9
    • San Antonio, Texas, United States, 78229
      • Endo Site 34
    • San Antonio, Texas, United States, 78258
      • Endo Site 22
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Endo Clinical Site 5
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Endo Site 32
    • Suffolk, Virginia, United States, 23434
      • Endo Site 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: CCH High Dose; Participants will receive a high dose of CCH on Day 1.	Biological: Collagenase Clostridium Histolyticum (CCH); Biologic: Intrafascial injection; Other Names: EN3835
Experimental: Group 2: CCH Low Dose; Participants will receive a low dose of CCH on Day 1.	Biological: Collagenase Clostridium Histolyticum (CCH); Biologic: Intrafascial injection; Other Names: EN3835
Placebo Comparator: Group 3: Placebo; Participants will receive matching placebo on Day 1.	Biological: Placebo; Intrafascial injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Number of Participants That Used Rescue Analgesic Medication	Up to Day 85
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
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

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Investigators: Study Director: Medical Director, Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Collagenases; Microbial Collagenase
• Other Study ID Numbers: EN3835-227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No