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

Last updated: March 19, 2025
Sponsor: Endo Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Desmoid Tumors

Aggressive Fibromatosis

Treatment

EN3835

Clinical Study ID

NCT05254457
EN3835-306
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have been enrolled and completed a sponsored-clinical study of EN3835 (for theEN3835-222 study, participants who completed the study are those that completed theDay 57 visit, were assessed for safety and received at least 1 dose of studyintervention).

  2. Willing and able to comply with all protocol required visits and assessments.

  3. Agree not to use opioids during the study period and has not used opioids 2 weeksprior to the Observational Day 1 Visit.

  4. Agree to not initiate or change use of orthotics or inserts designed to relievesymptoms of plantar fibromatosis during the study period.

  5. Willing and able to comply with all protocol required visits and assessments.

  6. Be adequately informed and understand the nature and risks of the study and be ableto provide consent

  7. If female, be of non-childbearing potential (history of hysterectomy, bilateraloophorectomy, bilateral tubal ligation, or postmenopausal with no history ofmenstrual flow in the 12 months prior to the Day 1 Visit), or, if of childbearingpotential, be nonpregnant, non-lactating and agree to use effective contraceptionwhen with a male partner for the duration of the study and for 28 days after anyactive treatment period.

  8. Have no significant medical history or examination findings related to theparticipant's plantar nodules, which in the investigator's opinion, would make theparticipant unsuitable for EN3835 administration.

Exclusion

Exclusion Criteria:

  1. Has any musculoskeletal, neuromuscular, neurosensory, or other neurological orrelated disorder that affects the participant's use of his or her feet and/or wouldimpair his/her completion of study assessments as determined by the investigator.

  2. Any other significant medical condition or had an SAE in the parent study which inthe investigator's opinion, would make the participant unsuitable for enrollment inthe study.

  3. Received or plans to receive surgical or non-surgical treatments on the foot ornodules that were treated.

  4. Has a known systemic allergy to collagenase or any other excipient of EN3835.

  5. Has a known bleeding disorder that would make the participant unsuitable fortreatment or retreatment in the study.

  6. Has significant medical history or examination findings related to the participant'splantar nodules, which in the investigator's opinion, would make the participantunsuitable for EN3835 administration.

  7. Has a known coagulation disorder or is taking any medications that would increasethe risk of bleeding (except <150mg of aspirin daily, 7 days prior to firstinjection and for the duration of the study.

Study Design

Total Participants: 145
Treatment Group(s): 1
Primary Treatment: EN3835
Phase: 3
Study Start date:
February 14, 2022
Estimated Completion Date:
March 21, 2024

Connect with a study center

  • Endo Clinical Trial Site #12

    Bakersfield, California 19331
    United States

    Site Not Available

  • Endo Clinical Trial Site #3

    Fresno, California 93710
    United States

    Site Not Available

  • Endo Clinical Trial Site #23

    La Mesa, California 91942
    United States

    Site Not Available

  • Endo Clinical Trial Site #23

    Mesa, California 91942
    United States

    Site Not Available

  • Endo Clinical Trial Site #13

    Tarzana, California 91356
    United States

    Site Not Available

  • Endo Clinical Trial Site #15

    Vista, California 92083
    United States

    Site Not Available

  • Endo Clinical Trial Site #18

    Whittier, California 90603
    United States

    Site Not Available

  • Endo Clinical Trial Site #24

    Miami, Florida 33176
    United States

    Site Not Available

  • Endo Clinical Trial Site #8

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Endo Clinical Trial Site #21

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Endo Clinical Trial Site #22

    Lawrenceville, Georgia 30043
    United States

    Site Not Available

  • Endo Clinical Trial Site #25

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Endo Clinical Trial Site #19

    Decatur, Illinois 62521
    United States

    Site Not Available

  • Endo Clinical Trial Site #2

    O'Fallon, Illinois 62269
    United States

    Site Not Available

  • Endo Clinical Trial Site #14

    Springfield, Illinois 62704
    United States

    Site Not Available

  • Endo Clinical Trial Site #6

    Pasadena, Maryland 21122
    United States

    Site Not Available

  • Endo Clinical Trial Site #16

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • Endo Clinical Trial Site #9

    York, Pennsylvania 17402
    United States

    Site Not Available

  • Endo Clinical Trial Site #4

    Bedford, Texas 76021
    United States

    Site Not Available

  • Endo Clinical Trial Site #17

    Dallas, Texas 75208
    United States

    Site Not Available

  • Endo Clinical Trial Site #26

    Dallas, Texas 75251
    United States

    Site Not Available

  • Endo Clinical Trial Site #5

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Endo Clinical Trial Site #27

    Georgetown, Texas 78628
    United States

    Site Not Available

  • Endo Clinical Trial Site #10

    Houston, Texas 77095
    United States

    Site Not Available

  • Endo Clinical Trial Site #7

    Houston, Texas 77027
    United States

    Site Not Available

  • Endo Clinical Trial Site #1

    McAllen, Texas 78501
    United States

    Site Not Available

  • Endo Clinical Trial Site #11

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Endo Clinical Trial Site #20

    Suffolk, Virginia 23434
    United States

    Site Not Available

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