Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis

NCT05152173 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EN3835-222
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 43

Brief Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis.

Conditions

Plantar Fibromatosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score

  FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment.

  Baseline (Day 1), Day 57

Secondary Outcomes (3)

• Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score

  Baseline (Day 1), Day 57

• Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale

  Day 57

• Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement

  Baseline (Day 1), Day 57

Study Arms (2)

EN3835 Group

EXPERIMENTAL

Participant will receive a maximum dose of up to 1.8mg of EN3835 injection

Biological: EN3835

Placebo Group

PLACEBO COMPARATOR

Participant will receive a matched Placebo injection

Other: Placebo

Interventions

Placebo OTHER

Participant will receive a matched Placebo injection

Placebo Group

EN3835 BIOLOGICAL

Participant will receive a maximum dose of up to1.8mg of EN3835 injection

EN3835 Group

Eligibility Criteria

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

You may qualify if:

• Has a diagnosis of plantar fibromatosis AND have at least 1 measurable, hard or firm, palpable fibrous nodule on clinical examination.
• Has no significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration.
• Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening Visit.
• Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
• 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 Screening Visit); or, if of childbearing potential, be non-pregnant, 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.
• 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.

You may not qualify if:

• Has the presence of non-plantar fibromatosis-related nodules on the foot/feet (eg, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
• Has any musculoskeletal, neuromuscular, neurosensory, 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.
• Has a known allergy to collagenase or any other excipient of EN3835.
• 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.
• Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being. If there is a history of such disease and the condition has been stable for greater than one year and is judged by the investigator not to interfere, the participant may be included, with the documented approval of the Medical Monitor.
• Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
• Has any other condition(s) that, in the investigator's opinion, might indicate the participants to be unsuitable for the study.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (43)

Endo Clinical Trial Site #29

Mesa, Arizona, 85206, United States

Location

Endo Clinical Trial Site #42

Tucson, Arizona, 85712, United States

Location

Endo Clinical Trial Site #15

Bakersfield, California, 93311, United States

Location

Endo Clinical Trial Site #41

Encinitas, California, 92024, United States

Location

Endo Clinical Trial Site #9

Fresno, California, 93710, United States

Location

Endo Clinical Trial Site #27

La Mesa, California, 91942, United States

Location

Endo Clinical Trial Site #30

Los Angeles, California, 90010, United States

Location

Endo Clinical Trial Site #12

Tarzana, California, 91356, United States

Location

Endo Clinical Trial Site #36

Torrance, California, 90502, United States

Location

Endo Clinical Trial Site #22

Vista, California, 92083, United States

Location

Endo Clinical Trial Site #13

Whittier, California, 90603, United States

Location

Endo Clinical Trial Site #16

Atlantis, Florida, 33462, United States

Location

Endo Clinical Trial Site #43

Jacksonville, Florida, 32209, United States

Location

Endo Clinical Trial Site #40

Miami, Florida, 33176, United States

Location

Endo Clinical Trial Site #10

Pinellas Park, Florida, 33782, United States

Location

Endo Clinical Trial Site #3

South Miami, Florida, 33143, United States

Location

Endo Clinical Trial Site #14

Sweetwater, Florida, 33172, United States

Location

Endo Clinical Trial Site #38

Lawrenceville, Georgia, 30043, United States

Location

Endo Clinical Trial Site #31

Meridian, Idaho, 83642, United States

Location

Endo Clinical Trial Site #32

Decatur, Illinois, 62521, United States

Location

Endo Clinical Trial Site #19

O'Fallon, Illinois, 62269, United States

Location

Endo Clinical Trial Site #33

Springfield, Illinois, 62704, United States

Location

Endo Clinical Trial Site #23

Pasadena, Maryland, 21122, United States

Location

Endo Clinical Trial Site #28

Jefferson City, Missouri, 65109, United States

Location

Endo Clinical Trial Site #20

Las Vegas, Nevada, 89119, United States

Location

Endo Clinical Trial Site #34

Oklahoma City, Oklahoma, 73109, United States

Location

Endo Clinical Trial Site #4

York, Pennsylvania, 17402, United States

Location

Endo Clinical Trial Site #35

Arlington, Texas, 76015, United States

Location

Endo Clinical Trial Site #5

Bedford, Texas, 76021, United States

Location

Endo Clinical Trial Site #24

Cedar Park, Texas, 78613, United States

Location

Endo Clinical Trial Site #17

Dallas, Texas, 75208, United States

Location

Endo Clinical Trial Site #2

Dallas, Texas, 75251, United States

Location

Endo Clinical Trial Site #7

Fort Worth, Texas, 76104, United States

Location

Endo Clinical Trial Site #39

Georgetown, Texas, 78628, United States

Location

Endo Clinical Trial Site #25

Houston, Texas, 77027, United States

Location

Endo Clinical Trial Site #8

Houston, Texas, 77095, United States

Location

Endo Clinical Trial Site #1

McAllen, Texas, 78501, United States

Location

Endo Clinical Trial Site #21

San Antonio, Texas, 78211, United States

Location

Endo Clinical Trial Site #6

San Antonio, Texas, 78229, United States

Location

Endo Clinical Trial Site #18

Salt Lake City, Utah, 84107, United States

Location

Endo Clinical Trial Site #26

Lynchburg, Virginia, 24501, United States

Location

Endo Clinical Trial Site #37

Midlothian, Virginia, 23114, United States

Location

Endo Clinical Trial Site #11

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

Results Point of Contact

• Title: Clinical Operations
• Organization: Endo Pharmaceuticals

clinicaltrials@endo.com

800-462-3636

Study Officials

• Luis Ortega, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 9, 2021
• Study Start: November 29, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

US (43)