Plantar FasciitisPhase 2NCT06169319
A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA)
A Phase 2 study testing Collagenase Clostridium Histolyticum (CCH) in people with Plantar Fasciitis, run by Endo USA Inc., a Keenova Therapeutics Company at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Collagenase Clostridium Histolyticum (CCH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 39 sitesUnited States
- Study dates
- 3 Jan 2024to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Endo Clinical Site 4
Bedford, Texas, 76021
Endo Site 24
Burleson, Texas, 76028
Endo Site 20
Castro Valley, California, 94546
Endo Site 37
Coconut Creek, Florida, 33073
Endo Site 13
Corona, California, 92882
Endo Site 17
Dallas, Texas, 75208
Endo Site 26
Dallas, Texas, 75235
Endo Site 18
Dallas, Texas, 75251
Endo Site 6
Encinitas, California, 92024
Endo Site 30
Fort Worth, Texas, 76104
Endo Site 11
Fresno, California, 93710
Endo Clinical Site 1
Georgetown, Texas, 78628
Endo Site 19
Grand Rapids, Michigan, 49525
Endo Site 15
Houston, Texas, 77027
Endo Site 7
Lawrenceville, Georgia, 30043
Endo Site 16
Los Angeles, California, 90010
Endo Site 40
Los Angeles, California, 90063
Endo Site 36
Malvern, Pennsylvania, 19355
Endo Site 9
McAllen, Texas, 78501
Endo Site 27
Missoula, Montana, 59804
Endo Site 25
Moore, Oklahoma, 73160
Endo Site 32
Newport News, Virginia, 23606
Endo Site 31
North Chicago, Illinois, 60064
Endo Site 28
O'Fallon, Illinois, 62269
Endo Site 33
Overland Park, Kansas, 66211
Endo Clinical Site 2
Pasadena, Maryland, 21122
Endo Clinical Site 3
Pinellas Park, Florida, 33782
Endo Site 39
Portland, Oregon, 97202
Endo Clinical Site 5
Salt Lake City, Utah, 84107
Endo Site 34
San Antonio, Texas, 78229
Endo Site 22
San Antonio, Texas, 78258
Endo Site 21
San Francisco, California, 94115
Endo Site 35
Shreveport, Louisiana, 71101
Endo Site 23
Stonecrest, Georgia, 30038
Endo Site 12
Suffolk, Virginia, 23434
Endo Site 14
Sweetwater, Florida, 33172
Endo Site 10
Tarzana, California, 91356
Endo Site 8
Tucson, Arizona, 85712
Endo Site 38
Westwood, New Jersey, 07675
About this study
Official 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)
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
- Being tested
- Collagenase Clostridium Histolyticum (CCH), Placebo
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium Histolyticum (CCH)Biological
Also called EN3835
Biologic: Intrafascial injection
PlaceboBiological
Intrafascial injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: CCH High Dose | Experimental | Participants will receive a high dose of CCH on Day 1. Receives: Biological: Collagenase Clostridium Histolyticum (CCH) |
| Group 2: CCH Low Dose | Experimental | Participants will receive a low dose of CCH on Day 1. Receives: Biological: Collagenase Clostridium Histolyticum (CCH) |
| Group 3: Placebo | Placebo comparator | Participants will receive matching placebo on Day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, Week 12
Secondary outcomes (10)
Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score
Measured: Baseline, up to Day 85
Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score
Measured: 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
Measured: Baseline, up to Week 12
Change from Baseline up to Day 85 in the FFI Pain Subscale Score
Measured: Baseline, up to Day 85
Change from Baseline up to Day 85 in the FFI Total Score
Measured: Baseline, up to Day 85
Number of Participants That Used Rescue Analgesic Medication
Measured: Up to Day 85
Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used
Measured: Up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Scale Score
Measured: Up to Day 85
Clinician Global Impression of Change (CGIC) Scale Score
Measured: Up to Day 85
Subject Satisfaction with Treatment Scale Score
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start3 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169319
- Sponsor's protocol ID
- EN3835-227
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2023
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06169319
- Acronym / sponsor ID
- EN3835-227
- Conditions
- Plantar Fasciitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: CCH High Dose | Experimental | Biological: Collagenase Clostridium Histolyticum (CCH)Participants will receive a high dose of CCH on Day 1. |
| Group 2: CCH Low Dose | Experimental | Biological: Collagenase Clostridium Histolyticum (CCH)Participants will receive a low dose of CCH on Day 1. |
| Group 3: Placebo | Placebo comparator | Biological: PlaceboParticipants will receive matching placebo on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase Clostridium Histolyticum (CCH)Also: EN3835Biologic: Intrafascial injection | Biological | Group 1: CCH High Dose, Group 2: CCH Low Dose |
| PlaceboIntrafascial injection | Biological | Group 3: Placebo |
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Yes
Related trials for Plantar Fasciitis
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Endo USA Inc., a Keenova Therapeutics Company
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collagenase Clostridium Histolyticum (CCH) in people with Plantar Fasciitis, run by Endo USA Inc., a Keenova Therapeutics Company at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.