Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis

NCT05254457 | Completed Phase 3 FDA Drug

• 1 other identifier: EN3835-306
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Plantar Fibromatosis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants reporting adverse events (AE)

  Proportion of participants reporting AE during the study assessed by incidence, severity and duration

  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

  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

  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

  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

  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

  Observational Days 60, 120, 180, 270, 360, and 450

Study Arms (2)

Observation Only Group

NO INTERVENTION

Treated or Retreated Group

EXPERIMENTAL

Biological: EN3835

Interventions

EN3835 BIOLOGICAL

Treatment or retreatment with EN3835

Treated or Retreated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (27)

Endo Clinical Trial Site #12

Bakersfield, California, 19331, United States

Location

Endo Clinical Trial Site #3

Fresno, California, 93710, United States

Location

Endo Clinical Trial Site #23

La Mesa, California, 91942, United States

Location

Endo Clinical Trial Site #13

Tarzana, California, 91356, United States

Location

Endo Clinical Trial Site #15

Vista, California, 92083, United States

Location

Endo Clinical Trial Site #18

Whittier, California, 90603, United States

Location

Endo Clinical Trial Site #24

Miami, Florida, 33176, United States

Location

Endo Clinical Trial Site #8

Pinellas Park, Florida, 33782, United States

Location

Endo Clinical Trial Site #21

Sweetwater, Florida, 33172, United States

Location

Endo Clinical Trial Site #22

Lawrenceville, Georgia, 30043, United States

Location

Endo Clinical Trial Site #25

Meridian, Idaho, 83642, United States

Location

Endo Clinical Trial Site #19

Decatur, Illinois, 62521, United States

Location

Endo Clinical Trial Site #2

O'Fallon, Illinois, 62269, United States

Location

Endo Clinical Trial Site #14

Springfield, Illinois, 62704, United States

Location

Endo Clinical Trial Site #6

Pasadena, Maryland, 21122, United States

Location

Endo Clinical Trial Site #16

Jefferson City, Missouri, 65109, United States

Location

Endo Clinical Trial Site #9

York, Pennsylvania, 17402, United States

Location

Endo Clinical Trial Site #4

Bedford, Texas, 76021, United States

Location

Endo Clinical Trial Site #17

Dallas, Texas, 75208, United States

Location

Endo Clinical Trial Site #26

Dallas, Texas, 75251, United States

Location

Endo Clinical Trial Site #5

Fort Worth, Texas, 76104, United States

Location

Endo Clinical Trial Site #27

Georgetown, Texas, 78628, United States

Location

Endo Clinical Trial Site #7

Houston, Texas, 77027, United States

Location

Endo Clinical Trial Site #10

Houston, Texas, 77095, United States

Location

Endo Clinical Trial Site #1

McAllen, Texas, 78501, United States

Location

Endo Clinical Trial Site #11

Salt Lake City, Utah, 84107, United States

Location

Endo Clinical Trial Site #20

Suffolk, Virginia, 23434, United States

Location

MeSH Terms

Conditions

Fibromatosis, Plantar

Condition Hierarchy (Ancestors)

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

Study Officials

• Nina Green

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: February 14, 2022
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (27)