Plantar FibromatosisPhase 3NCT05254457
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
A Phase 3 study testing EN3835 in people with Plantar Fibromatosis, run by Endo USA Inc., a Keenova Therapeutics Company at 27 sites in United States.
Trial summary
Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of EN3835 in the treatment and retreatment of 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 27 sitesUnited States
- Study dates
- 14 Feb 2022to 21 Mar 2024
- 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
- Have been enrolled and completed a sponsored-clinical study of EN3835 (for the EN3835-222 study, participants who completed the study are those that completed the Day 57 visit, were assessed for safety and received at least 1 dose of study intervention).
- Willing and able to comply with all protocol required visits and assessments.
- Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit.
- Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study 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
- 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 Day 1 Visit), or, if of childbearing potential, be nonpregnant, 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.
- Have no significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
Who cannot join
- Has any musculoskeletal, neuromuscular, neurosensory, or 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.
- Any other significant medical condition or had an SAE in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated.
- Has a known systemic allergy to collagenase or any other excipient of EN3835.
- Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study.
- Has significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Endo Clinical Trial Site #12
Bakersfield, California, 19331
Endo Clinical Trial Site #4
Bedford, Texas, 76021
Endo Clinical Trial Site #17
Dallas, Texas, 75208
Endo Clinical Trial Site #26
Dallas, Texas, 75251
Endo Clinical Trial Site #19
Decatur, Illinois, 62521
Endo Clinical Trial Site #5
Fort Worth, Texas, 76104
Endo Clinical Trial Site #3
Fresno, California, 93710
Endo Clinical Trial Site #27
Georgetown, Texas, 78628
Endo Clinical Trial Site #7
Houston, Texas, 77027
Endo Clinical Trial Site #10
Houston, Texas, 77095
Endo Clinical Trial Site #16
Jefferson City, Missouri, 65109
Endo Clinical Trial Site #23
La Mesa, California, 91942
Endo Clinical Trial Site #22
Lawrenceville, Georgia, 30043
Endo Clinical Trial Site #1
McAllen, Texas, 78501
Endo Clinical Trial Site #25
Meridian, Idaho, 83642
Endo Clinical Trial Site #24
Miami, Florida, 33176
Endo Clinical Trial Site #2
O'Fallon, Illinois, 62269
Endo Clinical Trial Site #6
Pasadena, Maryland, 21122
Endo Clinical Trial Site #8
Pinellas Park, Florida, 33782
Endo Clinical Trial Site #11
Salt Lake City, Utah, 84107
Endo Clinical Trial Site #14
Springfield, Illinois, 62704
Endo Clinical Trial Site #20
Suffolk, Virginia, 23434
Endo Clinical Trial Site #21
Sweetwater, Florida, 33172
Endo Clinical Trial Site #13
Tarzana, California, 91356
Endo Clinical Trial Site #15
Vista, California, 92083
Endo Clinical Trial Site #18
Whittier, California, 90603
Endo Clinical Trial Site #9
York, Pennsylvania, 17402
About this study
Official title: A Multi-Center, Open-Label, Extension Study to Evaluate the Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of EN3835 in the treatment and retreatment of plantar fibromatosis.
- Conditions
- Plantar Fibromatosis
- Being tested
- EN3835
- 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
Treatment or retreatment with EN3835
| Study group | Role | What they receive |
|---|---|---|
| Observation Only Group | No intervention | Not described |
| Treated or Retreated Group | Experimental | Not described Receives: Biological: EN3835 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants reporting adverse events (AE)
Proportion of participants reporting AE during the study assessed by incidence, severity and duration
Measured: Day 1 to Day 450
Secondary outcomes (24)
Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study
Change from baseline on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.
Measured: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study
Change from baseline on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.
Measured: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study
Change from baseline in the nodular hardness of the treated nodules measured by durometer
Measured: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline in the nodular consistency of the treated nodules by palpation in participants treated in the parent studies, and participants retreated in this study
Change from baseline in the nodular consistency of the treated nodules by palpation
Measured: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
Change from baseline on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)
Measured: Observational Days 60, 120, 180, 270, 360, and 450
Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study
Proportion of participants that meet Treatment Session 1 criteria
Measured: Days 180 or 270
Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
Proportion of participants reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale
Measured: Observational Days 60, 120, 180, 270, 360, and 450
Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
Proportion of participants reporting "Minimally Improved" (+1), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale
Measured: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study
Change from baseline (Retreatment Day 1) with EN3835 on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.
Measured: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237
Change from baseline (Retreatment) on the Foot Function Index (FFI) subscales (pain, difficulty, and activity limitation) in the parent studies, and participants retreated in this study
Change from baseline (Retreatment Day 1) with EN3835 on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.
Measured: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237
Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study
Change from baseline (Retreatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer
Measured: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Retreatment Day 1) in the nodular consistency of the treated nodules by palpation in the parent studies, and participants retreated in this study
Change from baseline (Retreatment Day 1) with EN3835 in the nodular consistency of the treated nodules by palpation
Measured: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
Change from baseline (Retreatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)
Measured: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
Proportion of participants reporting to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days
Measured: Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
Proportion of participants reporting "Minimally Improved" (+1), "Much Improved (+2)" or "Very Much Improved (+3) on the Clinician Global Impression of Change Scale on Retreatment Days
Measured: Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study
Change from baseline (Treatment Day 1) with EN3835 on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.
Measured: Change from baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study
Change from baseline (Treatment Day 1) with EN3835 on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme.
Measured: Change from Baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study
Change from baseline (Treatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer
Measured: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study
Change from baseline (Treatment Day 1) with EN3835 in the nodular consistency of the treated nodules be palpation
Measured: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
Change from baseline (Treatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)
Measured: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
Proportion of participants reporting to be "Quite Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale
Measured: Treatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
Proportion of participants reporting "Minimally Improved" (+1 ), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale
Measured: Treatment Days 15, 29, 43, 57, 117, 197, and 237
Presence of anti-AUX-I and anti-AUX-II antibody titer levels
Presence of anti-AUX-I and anti-AUX-II antibody titer levels in EN3835 treated and retreated participants
Measured: Retreatment/Treatment Day 57 and Day 450
Presence of neutralizing antibodies to AUX-I and AUX-II
Presence of neutralizing antibodies to AUX-I and AUX-II in EN3835 treated and retreated participants
Measured: Retreatment/ Treatment Day 57 and Day 450
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start14 Feb 2022
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
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
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nina Green, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254457
- Sponsor's protocol ID
- EN3835-306
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2022
- Last updated
- 21 Mar 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Extension Study to Evaluate the Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
- ClinicalTrials.gov ID
- NCT05254457
- Acronym / sponsor ID
- EN3835-306
- Conditions
- Plantar Fibromatosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 24 Feb 2022 (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.
Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of EN3835 in the treatment and retreatment of plantar fibromatosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation Only Group | No intervention | – |
| Treated or Retreated Group | Experimental | Biological: EN3835 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have been enrolled and completed a sponsored-clinical study of EN3835 (for the EN3835-222 study, participants who completed the study are those that completed the Day 57 visit, were assessed for safety and received at least 1 dose of study intervention).
- Willing and able to comply with all protocol required visits and assessments.
- Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit.
- Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
- Willing and able to comply with all protocol required visits and assessments.
Key exclusion criteria (7 listed)
- Has any musculoskeletal, neuromuscular, neurosensory, or 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.
- Any other significant medical condition or had an SAE in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated.
- Has a known systemic allergy to collagenase or any other excipient of EN3835.
- Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment 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 |
|---|---|---|
| EN3835Treatment or retreatment with EN3835 | Biological | Treated or Retreated Group |
Primary outcome
Proportion of participants reporting adverse events (AE)
Time frame: Day 1 to Day 450
Proportion of participants reporting AE during the study assessed by incidence, severity and duration
24 secondary outcomes
Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study
Time frame: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study
Time frame: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study
Time frame: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline in the nodular consistency of the treated nodules by palpation in participants treated in the parent studies, and participants retreated in this study
Time frame: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
Time frame: Observational Days 60, 120, 180, 270, 360, and 450
Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study
Time frame: Days 180 or 270
Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
Time frame: Observational Days 60, 120, 180, 270, 360, and 450
Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
Time frame: Observational Days 60, 120, 180, 270, 360, and 450
Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237
Change from baseline (Retreatment) on the Foot Function Index (FFI) subscales (pain, difficulty, and activity limitation) in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237
Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Retreatment Day 1) in the nodular consistency of the treated nodules by palpation in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
Time frame: Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
Time frame: Retreatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study
Time frame: Change from Baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Change from baseline (Treatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study
Time frame: Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study
Time frame: Treatment Days 15, 29, 43, 57, 117, 197, and 237
Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study
Time frame: Treatment Days 15, 29, 43, 57, 117, 197, and 237
Presence of anti-AUX-I and anti-AUX-II antibody titer levels
Time frame: Retreatment/Treatment Day 57 and Day 450
Presence of neutralizing antibodies to AUX-I and AUX-II
Time frame: Retreatment/ Treatment Day 57 and Day 450
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 21 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
Nina Green study director
Endo USA Inc., a Keenova Therapeutics Company
27 sites in 1 country: 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, run by Endo USA Inc., a Keenova Therapeutics Company at 27 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 8 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. 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?
Proportion of participants reporting adverse events (AE) (time frame: Day 1 to Day 450). 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 21 Mar 2025.