Plantar FibromatosisPhase 2NCT05152173
Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
A Phase 2 study testing EN3835 in people with Plantar Fibromatosis, run by Endo USA Inc., a Keenova Therapeutics Company at 43 sites in United States.
Trial summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fibromatosis
- 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
- 176 participants
- Where
- 43 sitesUnited States
- Study dates
- 29 Nov 2021to 10 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Has a diagnosis of plantar fibromatosis AND have at least 1 measurable, hard or firm, palpable fibrous nodule on clinical examination.
- Has no 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.
- Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening Visit.
- Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
- 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.
- Willing and able to comply with all protocol required visits and assessments.
- Be adequately informed and understand the nature and risks of the study and be able to provide consent.
Who cannot join
- Has the presence of non-plantar fibromatosis-related nodules on the foot/feet (eg, 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 feet and/or would impair his/her completion of study assessments as determined by the investigator.
- Has a known allergy to collagenase or any other excipient of EN3835.
- Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except <150mg of aspirin daily), 7 days prior to first injection and for the duration of the study.
- 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. If there is a history of such disease and the condition has been stable for greater than one year and is judged by the investigator not to interfere, the participant may be included, with the documented approval of the Medical Monitor.
- Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
- Has any other condition(s) that, in the investigator's opinion, might indicate the participants to be unsuitable for the study.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Endo Clinical Trial Site #35
Arlington, Texas, 76015
Endo Clinical Trial Site #16
Atlantis, Florida, 33462
Endo Clinical Trial Site #15
Bakersfield, California, 93311
Endo Clinical Trial Site #5
Bedford, Texas, 76021
Endo Clinical Trial Site #24
Cedar Park, Texas, 78613
Endo Clinical Trial Site #17
Dallas, Texas, 75208
Endo Clinical Trial Site #2
Dallas, Texas, 75251
Endo Clinical Trial Site #32
Decatur, Illinois, 62521
Endo Clinical Trial Site #41
Encinitas, California, 92024
Endo Clinical Trial Site #7
Fort Worth, Texas, 76104
Endo Clinical Trial Site #9
Fresno, California, 93710
Endo Clinical Trial Site #39
Georgetown, Texas, 78628
Endo Clinical Trial Site #25
Houston, Texas, 77027
Endo Clinical Trial Site #8
Houston, Texas, 77095
Endo Clinical Trial Site #43
Jacksonville, Florida, 32209
Endo Clinical Trial Site #28
Jefferson City, Missouri, 65109
Endo Clinical Trial Site #27
La Mesa, California, 91942
Endo Clinical Trial Site #20
Las Vegas, Nevada, 89119
Endo Clinical Trial Site #38
Lawrenceville, Georgia, 30043
Endo Clinical Trial Site #30
Los Angeles, California, 90010
Endo Clinical Trial Site #26
Lynchburg, Virginia, 24501
Endo Clinical Trial Site #1
McAllen, Texas, 78501
Endo Clinical Trial Site #31
Meridian, Idaho, 83642
Endo Clinical Trial Site #29
Mesa, Arizona, 85206
Endo Clinical Trial Site #40
Miami, Florida, 33176
Endo Clinical Trial Site #37
Midlothian, Virginia, 23114
Endo Clinical Trial Site #19
O'Fallon, Illinois, 62269
Endo Clinical Trial Site #34
Oklahoma City, Oklahoma, 73109
Endo Clinical Trial Site #23
Pasadena, Maryland, 21122
Endo Clinical Trial Site #10
Pinellas Park, Florida, 33782
Endo Clinical Trial Site #18
Salt Lake City, Utah, 84107
Endo Clinical Trial Site #21
San Antonio, Texas, 78211
Endo Clinical Trial Site #6
San Antonio, Texas, 78229
Endo Clinical Trial Site #3
South Miami, Florida, 33143
Endo Clinical Trial Site #33
Springfield, Illinois, 62704
Endo Clinical Trial Site #11
Suffolk, Virginia, 23434
Endo Clinical Trial Site #14
Sweetwater, Florida, 33172
Endo Clinical Trial Site #12
Tarzana, California, 91356
Endo Clinical Trial Site #36
Torrance, California, 90502
Endo Clinical Trial Site #42
Tucson, Arizona, 85712
Endo Clinical Trial Site #22
Vista, California, 92083
Endo Clinical Trial Site #13
Whittier, California, 90603
Endo Clinical Trial Site #4
York, Pennsylvania, 17402
About this study
Official title: Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis.
- Conditions
- Plantar Fibromatosis
- 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
Participant will receive a maximum dose of up to1.8mg of EN3835 injection
PlaceboOther
Participant will receive a matched Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| EN3835 Group | Experimental | Participant will receive a maximum dose of up to 1.8mg of EN3835 injection Receives: Biological: EN3835 |
| Placebo Group | Placebo comparator | Participant will receive a matched Placebo injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score
FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment.
Measured: Baseline (Day 1), Day 57
Secondary outcomes (3)
Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score
The FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. The FFI difficulty subscale consisted of 9 items which were scored on a scale of 0 ("No difficulty") to 4 ("A lot of difficulty") with a total score ranging from 0 to 36. The Total Combined score of pain and difficulty comprised scores of answered items in each subscale with a maximum total score range of 0 to 72. Lower scores indicated better foot function, while higher scores reflected greater impairment.
Measured: Baseline (Day 1), Day 57
Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale
The responder (by foot/feet) was defined as a participant with a response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" in the CGIC Scale. All participants who withdrew early from the study were considered as non-responders. If participant was treated for both feet, then the assessment could be combined at participant level using worst case approach, if one foot response was recorded as 'Minimal Improvement' and 'Very Much Improvement' in another foot, then response was considered as 'Minimal Improvement'.
Measured: Day 57
Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement
A durometer was used to measure the hardness of treated nodules, on a scale ranging from 0 to 100. Higher scores indicated a greater hardness.
Measured: Baseline (Day 1), Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start29 Nov 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Ortega, MD, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152173
- Sponsor's protocol ID
- EN3835-222
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
- ClinicalTrials.gov ID
- NCT05152173
- Acronym / sponsor ID
- EN3835-222
- Conditions
- Plantar Fibromatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN3835 Group | Experimental | Biological: EN3835Participant will receive a maximum dose of up to 1.8mg of EN3835 injection |
| Placebo Group | Placebo comparator | Other: PlaceboParticipant will receive a matched Placebo injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a diagnosis of plantar fibromatosis AND have at least 1 measurable, hard or firm, palpable fibrous nodule on clinical examination.
- Has no 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.
- Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening Visit.
- Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
- 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 (7 listed)
- Has the presence of non-plantar fibromatosis-related nodules on the foot/feet (eg, 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 feet and/or would impair his/her completion of study assessments as determined by the investigator.
- Has a known allergy to collagenase or any other excipient of EN3835.
- Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except <150mg of aspirin daily), 7 days prior to first injection and for the duration of the study.
- 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. If there is a history of such disease and the condition has been stable for greater than one year and is judged by the investigator not to interfere, the participant may be included, with the documented approval of the Medical Monitor.
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 |
|---|---|---|
| EN3835Participant will receive a maximum dose of up to1.8mg of EN3835 injection | Biological | EN3835 Group |
| PlaceboParticipant will receive a matched Placebo injection | Other | Placebo Group |
Primary outcome
Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score
Time frame: Baseline (Day 1), Day 57
FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment.
3 secondary outcomes
Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score
Time frame: Baseline (Day 1), Day 57
Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale
Time frame: Day 57
Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement
Time frame: Baseline (Day 1), Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Plantar Fibromatosis
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Ledderhose Disease: Radiotherapy or Not?
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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.
Luis Ortega, MD study director
Endo USA Inc., a Keenova Therapeutics Company
43 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 EN3835 in people with Plantar Fibromatosis, run by Endo USA Inc., a Keenova Therapeutics Company at 43 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 7 inclusion and 7 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Day 57 in the Foot Function Index (FFI) Pain Subscale Score (time frame: Baseline (Day 1), Day 57). 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 27 Mar 2026.