Plantar FibromatosisPhase 3STRIDENCT06151197
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
A Phase 3 study testing EN3835 in people with Plantar Fibromatosis and Ledderhose Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 66 sites in 2 countries.
Trial summary
This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fibromatosis, Ledderhose Disease
- What is being tested?
- EN3835
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 436 participants
- Where
- 66 sitesin 2 countries
- Study dates
- 28 Nov 2023to 9 Jun 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be an ambulatory male or female ≥18 years of age.
- Have a diagnosis of PFI.
- Have current foot pain due to PFI.
- Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol.
- If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
- Be capable of providing consent, are adequately informed, and understand the nature and risks of the study.
Who cannot join
- Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
- Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator.
- Has any significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration or required assessments and evaluations.
- Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
- Has a clinically significant laboratory abnormality.
- Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not to interfere with participation in the study, the participant may be included, with the documented approval of the medical monitor.
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- Has any other significant medical condition(s), which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Is pregnant or plans to become pregnant.
- Is breastfeeding or is providing or plans to provide breast milk in any manner during the study.
Trial locations and contacts
66 sites in 2 countries.
66 sites in 2 countries
United States63 sites
Endo Site 10
Altoona, Pennsylvania, 16602
Endo Site 48
Arlington, Texas, 76015
Endo Site 3
Bedford, Texas, 76021
Endo Site 51
Billings, Montana, 59101
Endo Site 41
Bountiful, Utah, 84010
Endo Site 43
Burleson, Texas, 76028
Endo Site 49
Castro Valley, California, 94546
Endo Site 39
Cerritos, California, 90703
Endo Site 31
Corona, California, 92882
Endo Site 25
Dallas, Texas, 75208
Endo Site 15
Durham, North Carolina, 27704
Endo Clinical Site 2
Encinitas, California, 92024
Endo Site 52
Falls Church, Virginia, 22042
Endo Site32
Fort Worth, Texas, 76104
Endo Site 8
Fresno, California, 93710
Endo Site 7
Georgetown, Texas, 78628
Endo Site 16
Grand Rapids, Michigan, 49525
Endo Site 22
Hialeah, Florida, 33013
Endo Site 55
Houston, Texas, 77027
Endo Site 40
Humble, Texas, 77338
Endo Site 59
Jacksonville, Florida, 32209
Endo Site 12
Jefferson City, Missouri, 65109
Endo Site 47
Johnstown, Colorado, 80534
Endo Site 28
Lancaster, California, 93534
Endo Site 24
Lawrenceville, Georgia, 30043
Endo Site 9
Los Angeles, California, 90010
Endo Site 53
Los Angeles, California, 90063
Endo Site 44
Malvern, Pennsylvania, 19355
Endo Site 4
McAllen, Texas, 78501
Endo Site 42
Mesa, Arizona, 85210
Endo Site 23
Miami, Florida, 33126
Endo Site 26
Miami, Florida, 33156
Endo Site 21
Miami, Florida, 33184
Endo Site 36
Missoula, Montana, 59804
Endo Site 35
North Miami Beach, Florida, 33169
Endo Site 27
O'Fallon, Illinois, 62269
Endo Site 45
Oak Brook, Illinois, 60523
Endo Site 63
Oklahoma City, Oklahoma, 73102
Endo Site 34
Oradell, New Jersey, 07649
Endo Site 54
Overland Park, Kansas, 66211
Endo Site 19
Palm Beach Gardens, Florida, 33410
Endo Site 65
Parker, Colorado, 80134
Endo Site 5
Pasadena, Maryland, 21122
Endo Clinical Site 1
Pinellas Park, Florida, 33782
Endo Site 14
Plantation, Florida, 33317
Endo Site 6
Salt Lake City, Utah, 84107
Endo Site 46
San Antonio, Texas, 78224
Endo Site 18
San Antonio, Texas, 78251
Endo Site 37
San Antonio, Texas, 78258
Endo Site 50
San Francisco, California, 94115
Endo Site 64
Scottsdale, Arizona, 85260
Endo Site 29
Sherman Oaks, California, 91403
Endo Site 56
Shreveport, Louisiana, 71101
Endo Site 38
State College, Pennsylvania, 16801
Endo Site 13
Suffolk, Virginia, 23434
Endo Site 60
Sweetwater, Florida, 33172
Endo Site 30
Tarzana, California, 91356
Endo Site 61
Torrance, California, 90502
Endo Site 11
Tucson, Arizona, 85712
Endo Site 62
Vineland, New Jersey, 08360
Endo Site 33
Virginia Gardens, Florida, 33166
Endo Site 17
Westminster, Colorado, 80031
Endo Site 20
Wilmington, North Carolina, 28412
Puerto Rico3 sites
Endo Site 70
Mayagüez, 00680
Endo Site 68
Mayagüez, 00682
Endo Site 69
Ponce, 00716
About this study
Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)
This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
- Conditions
- Plantar Fibromatosis, Ledderhose Disease
- Being tested
- EN3835, Placebo
- Medical subject headings
- Fibromatosis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN3835Biological
Biologic: EN3835 injection
PlaceboOther
Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| EN3835 | Experimental | Not described Receives: Biological: EN3835 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 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 (12)
Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score
Measured: Baseline, up to Day 85
Change from Baseline in the FFI Activity Limitation Subscale Score
Measured: Baseline, up to Day 85
Change from Baseline in the FFI Pain Subscale Score
Measured: Baseline, up to Day 85
Change from Baseline in the FFI Total Score
Measured: Baseline, up to Day 85
Number of Participants That Used Rescue Analgesic Medication
Measured: Up to Day 85
Amount of (milligrams [mg]) Rescue Analgesic Medication Used
Measured: Up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Score
Measured: Up to Day 85
Patient Global Impression of Severity (PGIS) Score
Measured: Up to Day 85
Clinician Global Impression of Change (CGIC) Score
Measured: Up to Day 85
Subject Satisfaction Score
Measured: Up to Day 85
Change from Baseline in Nodule Consistency (Firmness)
Measured: Baseline, up to Day 85
Change from Baseline in the Nodular Hardness of the Treated Nodules
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 posted30 Nov 2023
- Study start28 Nov 2023
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FibromatosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Ortega, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151197
- Sponsor's protocol ID
- EN3835-309
- Acronym
- STRIDE
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)
- ClinicalTrials.gov ID
- NCT06151197
- Acronym / sponsor ID
- STRIDE / EN3835-309
- Conditions
- Plantar Fibromatosis, Ledderhose Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 30 Nov 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 EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN3835 | Experimental | Biological: EN3835 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be an ambulatory male or female ≥18 years of age.
- Have a diagnosis of PFI.
- Have current foot pain due to PFI.
- Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol.
- If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
Key exclusion criteria (9 listed)
- Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
- Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator.
- Has any significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration or required assessments and evaluations.
- Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
- Has a clinically significant laboratory abnormality.
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 |
|---|---|---|
| EN3835Biologic: EN3835 injection | Biological | EN3835 |
| PlaceboPlacebo injection | Other | Placebo |
Primary outcome
Change from Baseline to 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
12 secondary outcomes
Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline in the FFI Activity Limitation Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline in the FFI Pain Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline 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
Amount of (milligrams [mg]) Rescue Analgesic Medication Used
Time frame: Up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Score
Time frame: Up to Day 85
Patient Global Impression of Severity (PGIS) Score
Time frame: Up to Day 85
Clinician Global Impression of Change (CGIC) Score
Time frame: Up to Day 85
Subject Satisfaction Score
Time frame: Up to Day 85
Change from Baseline in Nodule Consistency (Firmness)
Time frame: Baseline, up to Day 85
Change from Baseline in the Nodular Hardness of the Treated Nodules
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 14 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Plantar Fibromatosis
Active, not recruitingPhase 3
Ledderhose Disease: Radiotherapy or Not?
Ledderhose Disease
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.
Louis Ortega study director
Endo USA Inc., a Keenova Therapeutics Company
66 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EN3835 in people with Plantar Fibromatosis and Ledderhose Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 66 sites in 2 countries.
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 6 inclusion and 9 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 to 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 14 Oct 2026.