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

Primary Purpose

Plantar Fibromatosis

Status

Enrolling by invitation

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

EN3835

About this trial

This is an interventional treatment trial for Plantar Fibromatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation Only Group

Treated or Retreated Group

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants reporting adverse events (AE)

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

Secondary Outcome Measures

Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study

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.

Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study

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.

Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study

Change from baseline in the nodular hardness of the treated nodules measured by durometer

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

Change from baseline in the nodular consistency of the treated nodules by palpation

Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study

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

Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study

Proportion of participants that meet Treatment Session 1 criteria

Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study

Proportion of participants reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study

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

Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study

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.

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

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.

Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study

Change from baseline (Retreatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer

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

Change from baseline (Retreatment Day 1) with EN3835 in the nodular consistency of the treated nodules by palpation

Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study

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

Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study

Proportion of participants reporting to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days

Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study

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

Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study

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.

Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study

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.

Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study

Change from baseline (Treatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer

Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study

Change from baseline (Treatment Day 1) with EN3835 in the nodular consistency of the treated nodules be palpation

Change from baseline (Treatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study

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

Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study

Proportion of participants reporting to be "Quite Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study

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

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

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

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

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

Full Information

NCT ID

NCT05254457

First Posted

February 15, 2022

Last Updated

September 19, 2022

Sponsor

Endo Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05254457

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 14, 2022 (Actual)

Primary Completion Date

February 20, 2026 (Anticipated)

Study Completion Date

February 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endo Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 and assess the efficacy and safety of EN3835 in the treatment and retreatment of Plantar Fibromatosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plantar Fibromatosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

694 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Observation Only Group

Arm Type

No Intervention

Arm Title

Treated or Retreated Group

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

EN3835

Intervention Description

Treatment or retreatment with up to two doses of EN3835

Primary Outcome Measure Information:

Title

Proportion of participants reporting adverse events (AE)

Description

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

Time Frame

Day 1 to Day 450

Secondary Outcome Measure Information:

Title

Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study

Description

Time Frame

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

Title

Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study

Description

Time Frame

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

Title

Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study

Description

Change from baseline in the nodular hardness of the treated nodules measured by durometer

Time Frame

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

Title

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

Description

Change from baseline in the nodular consistency of the treated nodules by palpation

Time Frame

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

Title

Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study

Description

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

Time Frame

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

Title

Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study

Description

Proportion of participants that meet Treatment Session 1 criteria

Time Frame

Days 180 or 270

Title

Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study

Description

Proportion of participants reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

Time Frame

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

Title

Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study

Description

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

Time Frame

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

Title

Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study

Description

Time Frame

Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237

Title

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

Description

Time Frame

Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237

Title

Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study

Description

Change from baseline (Retreatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer

Time Frame

Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237

Title

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

Description

Change from baseline (Retreatment Day 1) with EN3835 in the nodular consistency of the treated nodules by palpation

Time Frame

Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study

Description

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

Time Frame

Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study

Description

Proportion of participants reporting to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days

Time Frame

Retreatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study

Description

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

Time Frame

Retreatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study

Description

Time Frame

Change from baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study

Description

Time Frame

Change from Baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study

Description

Change from baseline (Treatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer

Time Frame

Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study

Description

Change from baseline (Treatment Day 1) with EN3835 in the nodular consistency of the treated nodules be palpation

Time Frame

Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Change from baseline (Treatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study

Description

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

Time Frame

Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study

Description

Proportion of participants reporting to be "Quite Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale

Time Frame

Treatment Days 15, 29, 43, 57, 117, 197, and 237

Title

Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study

Description

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

Time Frame

Treatment Days 15, 29, 43, 57, 117, 197, and 237

Title

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

Description

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

Time Frame

Retreatment/Treatment Day 57 and Day 450

Title

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

Description

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

Time Frame

Retreatment/ Treatment Day 57 and Day 450

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nina Green

Organizational Affiliation

Endo Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Endo Clinical Trial Site #12

City

Bakersfield

State/Province

California

ZIP/Postal Code

19331

Country

United States

Facility Name

Endo Clinical Trial Site #3

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Endo Clinical Trial Site #23

City

Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Endo Clinical Trial Site #13

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Endo Clinical Trial Site #15

City

Vista

State/Province

California

ZIP/Postal Code

92083

Country

United States

Facility Name

Endo Clinical Trial Site #18

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

Endo Clinical Trial Site #24

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Endo Clinical Trial Site #8

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33782

Country

United States

Facility Name

Endo Clinical Trial Site #21

City

Sweetwater

State/Province

Florida

ZIP/Postal Code

33172

Country

United States

Facility Name

Endo Clinical Trial Site #22

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30043

Country

United States

Facility Name

Endo Clinical Trial Site #25

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Endo Clinical Trial Site #19

City

Decatur

State/Province

Illinois

ZIP/Postal Code

62521

Country

United States

Facility Name

Endo Clinical Trial Site #2

City

O'Fallon

State/Province

Illinois

ZIP/Postal Code

62269

Country

United States

Facility Name

Endo Clinical Trial Site #14

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Endo Clinical Trial Site #6

City

Pasadena

State/Province

Maryland

ZIP/Postal Code

21122

Country

United States

Facility Name

Endo Clinical Trial Site #16

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Endo Clinical Trial Site #9

City

York

State/Province

Pennsylvania

ZIP/Postal Code

17402

Country

United States

Facility Name

Endo Clinical Trial Site #4

City

Bedford

State/Province

Texas

ZIP/Postal Code

76021

Country

United States

Facility Name

Endo Clinical Trial Site #17

City

Dallas

State/Province

Texas

ZIP/Postal Code

75208

Country

United States

Facility Name

Endo Clinical Trial Site #26

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

Endo Clinical Trial Site #5

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Endo Clinical Trial Site #27

City

Georgetown

State/Province

Texas

ZIP/Postal Code

78628

Country

United States

Facility Name

Endo Clinical Trial Site #7

City

Houston

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

Facility Name

Endo Clinical Trial Site #10

City

Houston

State/Province

Texas

ZIP/Postal Code

77095

Country

United States

Facility Name

Endo Clinical Trial Site #1

City

McAllen

State/Province

Texas

ZIP/Postal Code

78501

Country

United States

Facility Name

Endo Clinical Trial Site #11

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Endo Clinical Trial Site #20

City

Suffolk

State/Province

Virginia

ZIP/Postal Code

23434

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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

Plantar Fibromatosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial