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

NCT06169319 | Completed Phase 2 FDA Drug

• 1 other identifier: EN3835-227
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 39

Brief Summary

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.

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (3)

Group 1: CCH High Dose

EXPERIMENTAL

Participants will receive a high dose of CCH on Day 1.

Biological: Collagenase Clostridium Histolyticum (CCH)

Group 2: CCH Low Dose

EXPERIMENTAL

Participants will receive a low dose of CCH on Day 1.

Biological: Collagenase Clostridium Histolyticum (CCH)

Group 3: Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo on Day 1.

Biological: Placebo

Interventions

Collagenase Clostridium Histolyticum (CCH) BIOLOGICAL

Biologic: Intrafascial injection

Also known as: EN3835

Group 1: CCH High Dose; Group 2: CCH Low Dose

Placebo BIOLOGICAL

Intrafascial injection

Group 3: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (39)

Endo Site 8

Tucson, Arizona, 85712, United States

Location

Endo Site 20

Castro Valley, California, 94546, United States

Location

Endo Site 13

Corona, California, 92882, United States

Location

Endo Site 6

Encinitas, California, 92024, United States

Location

Endo Site 11

Fresno, California, 93710, United States

Location

Endo Site 16

Los Angeles, California, 90010, United States

Location

Endo Site 40

Los Angeles, California, 90063, United States

Location

Endo Site 21

San Francisco, California, 94115, United States

Location

Endo Site 10

Tarzana, California, 91356, United States

Location

Endo Site 37

Coconut Creek, Florida, 33073, United States

Location

Endo Clinical Site 3

Pinellas Park, Florida, 33782, United States

Location

Endo Site 14

Sweetwater, Florida, 33172, United States

Location

Endo Site 7

Lawrenceville, Georgia, 30043, United States

Location

Endo Site 23

Stonecrest, Georgia, 30038, United States

Location

Endo Site 31

North Chicago, Illinois, 60064, United States

Location

Endo Site 28

O'Fallon, Illinois, 62269, United States

Location

Endo Site 33

Overland Park, Kansas, 66211, United States

Location

Endo Site 35

Shreveport, Louisiana, 71101, United States

Location

Endo Clinical Site 2

Pasadena, Maryland, 21122, United States

Location

Endo Site 19

Grand Rapids, Michigan, 49525, United States

Location

Endo Site 27

Missoula, Montana, 59804, United States

Location

Endo Site 38

Westwood, New Jersey, 07675, United States

Location

Endo Site 25

Moore, Oklahoma, 73160, United States

Location

Endo Site 39

Portland, Oregon, 97202, United States

Location

Endo Site 36

Malvern, Pennsylvania, 19355, United States

Location

Endo Clinical Site 4

Bedford, Texas, 76021, United States

Location

Endo Site 24

Burleson, Texas, 76028, United States

Location

Endo Site 17

Dallas, Texas, 75208, United States

Location

Endo Site 26

Dallas, Texas, 75235, United States

Location

Endo Site 18

Dallas, Texas, 75251, United States

Location

Endo Site 30

Fort Worth, Texas, 76104, United States

Location

Endo Clinical Site 1

Georgetown, Texas, 78628, United States

Location

Endo Site 15

Houston, Texas, 77027, United States

Location

Endo Site 9

McAllen, Texas, 78501, United States

Location

Endo Site 34

San Antonio, Texas, 78229, United States

Location

Endo Site 22

San Antonio, Texas, 78258, United States

Location

Endo Clinical Site 5

Salt Lake City, Utah, 84107, United States

Location

Endo Site 32

Newport News, Virginia, 23606, United States

Location

Endo Site 12

Suffolk, Virginia, 23434, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Medical Director

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: January 3, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (39)