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

Sponsor
Endo Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05152173
Collaborator
(none)
216
Enrollment
40
Locations
2
Arms
10.9
Anticipated Duration (Months)
5.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: EN3835
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
Actual Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Oct 26, 2022
Anticipated Study Completion Date :
Oct 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: EN3835 Group

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

Biological: EN3835
Participant will receive a maximum dose of up to1.8mg of EN3835 injection
Placebo Comparator: Placebo Group

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

Other: Placebo
Participant will receive a maximum dose of up to1.8mg of Placebo injection

Outcome Measures

Primary Outcome Measures

  1. Mean Change between EN3835 and placebo in the Foot Function Index (FFI) pain subscale [Baseline (Day1) to Day 57]

    Mean change on the foot pain subscale (total score on 9 items) of the FFI ranging from 0 ("None") to 4 ("Extreme").

Secondary Outcome Measures

  1. Mean Change with EN3835 and placebo in the FFI pain subscale [Mean Change from Baseline (Day 1) to Days 15, 29, 43, and 57]

    Mean change on the foot pain subscale (total score on 9 items) of the FFI ranging from 0 ("None") to 4 ("Extreme").

  2. Mean change between EN3835 and placebo on the total score of the FFI pain and difficult subscales (combined) [Baseline (Day 1) to Day 57]

    Mean change between EN3835 and placebo on the total score of the FFI pain and difficult subscales (combined)

  3. Mean change between EN3835 and placebo on the total score of the FFI pain and difficult subscales (combined) [Mean change from Baseline (Day 1) to Days15, 29, 43, and 57]

    Mean change between EN3835 and placebo on the total score of the FFI pain and difficult subscales (combined)

  4. Change in the proportion of EN3835-treated participants and those receiving only placebo reporting a 7-point scale Clinician Global Impression of Change Scale [Days 15, 29, 43, and 57]

    Change in the proportion of EN3835-treated participants and those receiving only placebo reporting a 7-point scale Clinician Global Impression of Change Scale ranging from -3 ("Very Much Worse") to +3 ("Very Much Improvement")

  5. Mean change between EN3835 and placebo in the nodular hardness of the treated nodules by durometer measurement [Baseline (Day 1) to Day 57]

    Mean change between EN3835 and placebo in the nodular hardness of the treated nodules by durometer measurement

  6. Mean change from Baseline in the nodular hardness of the treated nodules by durometer measurements with EN3835 vs placebo [Baseline (Day 1) to Days 15, 29, 43, 57]

    Mean change from Baseline in the nodular hardness of the treated nodules by durometer measurements with EN3835 vs placebo

  7. Safety of EN3835 as assessed by incidence, severity, and duration of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) [Up to Day 57]

    Safety of EN3835 as assessed by incidence, severity, and duration of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)

  8. Presence of anti-AUX-I and anti-AUX-II antibody titer levels in EN3835 treated participants [Day 1 and Day 57]

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

  9. Presence of neutralizing antibodies to AUX-I and AUX-II in EN3835 treated-participants [Day 1 and Day 57]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Has a diagnosis of plantar fibromatosis AND have at least 1 measurable, hard or firm, palpable fibrous nodule on clinical examination.

  2. 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.

  3. Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening Visit.

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

  5. 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.

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

  7. Be adequately informed and understand the nature and risks of the study and be able to provide consent.

Exclusion Criteria:

  1. 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).

  2. 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.

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

  4. 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.

  5. 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.

  6. 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.

  7. Has any other condition(s) that, in the investigator's opinion, might indicate the participants to be unsuitable for the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Endo Clinical Trial Site #29 Mesa Arizona United States 85206
2 Endo Clinical Trial Site #15 Bakersfield California United States 93311
3 Endo Clinical Trial Site #9 Fresno California United States 93710
4 Endo Clinical Trial Site #27 La Mesa California United States 91942
5 Endo Clinical Trial Site #30 Los Angeles California United States 90010
6 Endo Clinical Trial Site #12 Tarzana California United States 91356
7 Endo Clinical Trial Site #36 Torrance California United States 90502
8 Endo Clinical Trial Site #22 Vista California United States 92083
9 Endo Clinical Trial Site #13 Whittier California United States 90603
10 Endo Clinical Trial Site #16 Atlantis Florida United States 33462
11 Endo Clinical Trial Site #40 Miami Florida United States 33176
12 Endo Clinical Trial Site #10 Pinellas Park Florida United States 33782
13 Endo Clinical Trial Site #3 South Miami Florida United States 33143
14 Endo Clinical Trial Site #14 Sweetwater Florida United States 33172
15 Endo Clinical Trial Site #38 Lawrenceville Georgia United States 30043
16 Endo Clinical Trial Site #31 Meridian Idaho United States 83642
17 Endo Clinical Trial Site #32 Decatur Illinois United States 62521
18 Endo Clinical Trial Site #19 O'Fallon Illinois United States 62269
19 Endo Clinical Trial Site #33 Springfield Illinois United States 62704
20 Endo Clinical Trial Site #23 Pasadena Maryland United States 21122
21 Endo Clinical Trial Site #28 Jefferson City Missouri United States 65109
22 Endo Clinical Trial Site #20 Las Vegas Nevada United States 89119
23 Endo Clinical Trial Site #34 Oklahoma City Oklahoma United States 73109
24 Endo Clinical Trial Site #4 York Pennsylvania United States 17402
25 Endo Clinical Trial Site #35 Arlington Texas United States 76015
26 Endo Clinical Trial Site #5 Bedford Texas United States 76021
27 Endo Clinical Trial Site #24 Cedar Park Texas United States 78613
28 Endo Clinical Trial Site #17 Dallas Texas United States 75208
29 Endo Clinical Trial Site #2 Dallas Texas United States 75251
30 Endo Clinical Trial Site #7 Fort Worth Texas United States 76104
31 Endo Clinical Trial Site #39 Georgetown Texas United States 78628
32 Endo Clinical Trial Site #25 Houston Texas United States 77027
33 Endo Clinical Trial Site #8 Houston Texas United States 77095
34 Endo Clinical Trial Site #1 McAllen Texas United States 78501
35 Endo Clinical Trial Site #21 San Antonio Texas United States 78211
36 Endo Clinical Trial Site #6 San Antonio Texas United States 78229
37 Endo Clinical Trial Site #18 Salt Lake City Utah United States 84107
38 Endo Clinical Trial Site #26 Lynchburg Virginia United States 24501
39 Endo Clinical Trial Site #37 Midlothian Virginia United States 23114
40 Endo Clinical Trial Site #11 Suffolk Virginia United States 23434

Sponsors and Collaborators

  • Endo Pharmaceuticals

Investigators

  • Study Director: Nina Green, Endo Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05152173
Other Study ID Numbers:
  • EN3835-222
First Posted:
Dec 9, 2021
Last Update Posted:
May 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fibroma
Fibromatosis, Plantar

Study Results

No Results Posted as of May 5, 2022