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

Phase 2

Completed

Interventions: Biological: Collagenase Clostridium Histolyticum (CCH)
Biological: Placebo

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Group 1: CCH High Dose	Collagenase Clostridium Histolyticum (CCH)	Participants will receive a high dose of CCH on Day 1.
Group 2: CCH Low Dose	Collagenase Clostridium Histolyticum (CCH)	Participants will receive a low dose of CCH on Day 1.
Group 3: Placebo	Placebo	Participants will receive matching placebo on Day 1.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from Baseline up to Day 85 in the FFI Pain Subscale Score	Baseline, up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Scale Score	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 Day 85 in the FFI Total Score	Baseline, 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
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
Subject Satisfaction with Treatment Scale Score	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
Clinician Global Impression of Change (CGIC) Scale Score	Up to Day 85

Locations (39): Endo Site 8
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Tucson, Arizona, United States
Endo Site 20
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Castro Valley, California, United States
Endo Site 13
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Corona, California, United States
Endo Site 6
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Encinitas, California, United States
Endo Site 11
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Fresno, California, United States
Endo Site 16
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Los Angeles, California, United States
Endo Site 40
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Los Angeles, California, United States
Endo Site 21
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San Francisco, California, United States
Endo Site 10
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Tarzana, California, United States
Endo Site 37
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Coconut Creek, Florida, United States
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Endo Site 8
🇺🇸Tucson, Arizona, United States