Skip to main content
OpenTrials
Completed

NCT Number: NCT05254457

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plantar Fibromatosis Connective Tissue Diseases Contracture Fibroma Fibromatosis, Plantar Foot Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endo Clinical Trial Site #12, Bakersfield, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

EN3835

Biological

Treatment or retreatment with EN3835

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 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.

  2. 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 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.

  3. 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 hardness of the treated nodules measured by durometer

  4. 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 in the nodular consistency of the treated nodules by palpation

  5. 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

    Change from baseline on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)

  6. 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 that meet Treatment Session 1 criteria

  7. 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 reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

  8. 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

    Proportion of participants reporting "Minimally Improved" (+1), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale

  9. 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 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.

  10. 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 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.

  11. 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) with EN3835 in the nodular hardness of the treated nodules measured by durometer

  12. 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) with EN3835 in the nodular consistency of the treated nodules by palpation

  13. 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

    Change from baseline (Retreatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)

  14. 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 to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days

  15. 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

    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

  16. 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) 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.

  17. 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) 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.

  18. 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) with EN3835 in the nodular hardness of the treated nodules measured by durometer

  19. 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) with EN3835 in the nodular consistency of the treated nodules be palpation

  20. 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

    Change from baseline (Treatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable)

  21. 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 to be "Quite Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

  22. 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

    Proportion of participants reporting "Minimally Improved" (+1 ), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale

  23. Presence of anti-AUX-I and anti-AUX-II antibody titer levels

    Time frame: Retreatment/Treatment Day 57 and Day 450

    Presence of anti-AUX-I and anti-AUX-II antibody titer levels in EN3835 treated and retreated participants

  24. Presence of neutralizing antibodies to AUX-I and AUX-II

    Time frame: Retreatment/ Treatment Day 57 and Day 450

    Presence of neutralizing antibodies to AUX-I and AUX-II in EN3835 treated and retreated participants

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.