A Phase 2 interventional study of Collagenase Clostridium Histolyticum (CCH) and Placebo in Plantar Fasciitis, sponsored by Endo USA Inc., a Keenova Therapeutics Company. Completed at 39 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Endo USA Inc., a Keenova Therapeutics Company · Phase 2, Interventional, and Treatment
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.
267 studies on the registry are indexed under Fasciitis, Plantar; 70 are open to participants now.
This study's enrollment of 231 is above the median of 56 across 233 interventional studies indexed under Fasciitis, Plantar.
Browse Fasciitis, Plantar studies →Endo USA Inc., a Keenova Therapeutics Company is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will receive a high dose of CCH on Day 1.
Biological: Collagenase Clostridium Histolyticum (CCH)
Participants will receive a low dose of CCH on Day 1.
Biological: Collagenase Clostridium Histolyticum (CCH)
Participants will receive matching placebo on Day 1.
Biological: Placebo
Biologic: Intrafascial injection
Also known as: EN3835
Intrafascial injection
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
Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score
Time frame: 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
Time frame: Baseline, up to Week 12
Change from Baseline up to Day 85 in the FFI Pain Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline up to Day 85 in the FFI Total Score
Time frame: Baseline, up to Day 85
Number of Participants That Used Rescue Analgesic Medication
Time frame: Up to Day 85
Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used
Time frame: Up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Scale Score
Time frame: Up to Day 85
Clinician Global Impression of Change (CGIC) Scale Score
Time frame: Up to Day 85
Subject Satisfaction with Treatment Scale Score
Time frame: Up to Day 85
Plan to share: Yes
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Endo USA Inc., a Keenova Therapeutics Company