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Completed

NCT Number: NCT06169319

A Study to Assess Collagenase Clostridium Histolyticum (CCH) 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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Endo Site 8, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collagenase Clostridium Histolyticum (CCH)

Biological

Biologic: Intrafascial injection

Other names: EN3835

Placebo

Biological

Intrafascial injection

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)

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score

    Time frame: Baseline, up to Day 85

  2. Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score

    Time frame: Baseline, up to Day 85

  3. Change from Baseline up to Week 12 in the Weekly Mean of the ADP Score as Measured on the Pain Intensity NRS

    Time frame: Baseline, up to Week 12

  4. Change from Baseline up to Day 85 in the FFI Pain Subscale Score

    Time frame: Baseline, up to Day 85

  5. Change from Baseline up to Day 85 in the FFI Total Score

    Time frame: Baseline, up to Day 85

  6. Number of Participants That Used Rescue Analgesic Medication

    Time frame: Up to Day 85

  7. Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used

    Time frame: Up to Day 85

  8. Patient Global Impression of Change (PGIC) Foot Pain Scale Score

    Time frame: Up to Day 85

  9. Clinician Global Impression of Change (CGIC) Scale Score

    Time frame: Up to Day 85

  10. Subject Satisfaction with Treatment Scale Score

    Time frame: Up to Day 85

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2023
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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