A Phase 3 interventional study of EN3835 in Plantar Fibromatosis, sponsored by Endo Pharmaceuticals. Completed at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 3, Interventional, and Treatment
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.
Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: EN3835
Treatment or retreatment with EN3835
Proportion of participants reporting adverse events (AE)
Proportion of participants reporting AE during the study assessed by incidence, severity and duration
Time frame: Day 1 to Day 450
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.
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
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.
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
Change from baseline in the nodular hardness of the treated nodules measured by durometer
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
Change from baseline in the nodular consistency of the treated nodules by palpation
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
Change from baseline on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)
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
Proportion of participants that meet Treatment Session 1 criteria
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
Proportion of participants reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale
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
Proportion of participants reporting "Minimally Improved" (+1), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale
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
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.
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
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.
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
Change from baseline (Retreatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer
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
Change from baseline (Retreatment Day 1) with EN3835 in the nodular consistency of the treated nodules by palpation
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
Change from baseline (Retreatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)
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
Proportion of participants reporting to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days
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
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
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
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.
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
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.
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
Change from baseline (Treatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer
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
Change from baseline (Treatment Day 1) with EN3835 in the nodular consistency of the treated nodules be palpation
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
Change from baseline (Treatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)
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
Proportion of participants reporting to be "Quite Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale
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
Proportion of participants reporting "Minimally Improved" (+1 ), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale
Time frame: 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
Time frame: 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
Time frame: Retreatment/ Treatment Day 57 and Day 450
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Mar 2024, 25 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Microbial Collagenase
Fibromatosis, Plantar