Trial Title:
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
NCT ID:
NCT06151197
Condition:
Plantar Fibromatosis
Ledderhose Disease
Conditions: Official terms:
Fibroma
Fibromatosis, Plantar
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
EN3835
Description:
Biologic: EN3835 injection
Arm group label:
EN3835
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo injection
Arm group label:
Placebo
Summary:
This study will assess the efficacy, safety, and tolerability of EN3835 compared to
placebo in the treatment of PFI (also known as Ledderhose disease).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Be an ambulatory male or female ≥18 years of age.
- Have a diagnosis of PFI.
- Have current foot pain due to PFI.
- Agree not to use prohibited medication, throughout the study, and not use any
medication to treat PFI pain, except as permitted per the protocol.
- 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.
- Be capable of providing consent, are adequately informed, and understand the nature
and risks of the study.
Key Exclusion Criteria:
- Has the presence of non-PFI-related nodules on the foot (for example, 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 foot and/or would impair
his/her completion of study assessments as determined by the investigator.
- Has any 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 or required assessments
and evaluations.
- Has a known bleeding disorder which would make the participant unsuitable for
enrollment in the study.
- Has a clinically significant laboratory abnormality.
- 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, or
any significant hematological, endocrine, cardiovascular, respiratory, renal,
hepatic, or gastrointestinal disease. If there is a history of such disease but the
condition has been stable for greater than 1 year and is judged by the investigator
not to interfere with participation in the study, the participant may be included,
with the documented approval of the medical monitor.
- Has any other significant medical condition(s), which in the investigator's opinion,
would make the participant unsuitable for enrollment in the study.
- Is pregnant or plans to become pregnant.
- Is breastfeeding or is providing or plans to provide breast milk in any manner
during the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Endo Site 42
Address:
City:
Mesa
Zip:
85210
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 11
Address:
City:
Tucson
Zip:
85712
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 49
Address:
City:
Castro Valley
Zip:
94546
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 39
Address:
City:
Cerritos
Zip:
90703
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 31
Address:
City:
Corona
Zip:
92882
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Clinical Site 2
Address:
City:
Encinitas
Zip:
92024
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 8
Address:
City:
Fresno
Zip:
93710
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 28
Address:
City:
Lancaster
Zip:
93534
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 9
Address:
City:
Los Angeles
Zip:
90010
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 53
Address:
City:
Los Angeles
Zip:
90063
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 50
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 29
Address:
City:
Tarzana
Zip:
91356
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 30
Address:
City:
Tarzana
Zip:
91356
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 47
Address:
City:
Johnstown
Zip:
80535
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 17
Address:
City:
Westminster
Zip:
80031
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 52
Address:
City:
Washington
Zip:
20036
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 22
Address:
City:
Hialeah
Zip:
33013
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 19
Address:
City:
Jupiter
Zip:
33458
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 33
Address:
City:
Medley
Zip:
33166
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 23
Address:
City:
Miami
Zip:
33126
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 21
Address:
City:
Miami
Zip:
33165
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 35
Address:
City:
North Miami Beach
Zip:
33169
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Clinical Site 1
Address:
City:
Pinellas Park
Zip:
33782
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 14
Address:
City:
Plantation
Zip:
33317
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 26
Address:
City:
South Miami
Zip:
33143
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 24
Address:
City:
Lawrenceville
Zip:
30043
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 27
Address:
City:
O'Fallon
Zip:
62269
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 45
Address:
City:
Oakbrook Terrace
Zip:
60523
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 54
Address:
City:
Overland Park
Zip:
66211
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 56
Address:
City:
Shreveport
Zip:
71101
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 5
Address:
City:
Pasadena
Zip:
21122
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 16
Address:
City:
Grand Rapids
Zip:
49525
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 12
Address:
City:
Jefferson City
Zip:
65109
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 51
Address:
City:
Billings
Zip:
59101
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 36
Address:
City:
Missoula
Zip:
59804
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 34
Address:
City:
Westwood
Zip:
07675
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 15
Address:
City:
Durham
Zip:
27704
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 20
Address:
City:
Wilmington
Zip:
28412
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 10
Address:
City:
Altoona
Zip:
16602
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 44
Address:
City:
Malvern
Zip:
19355
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 38
Address:
City:
State College
Zip:
16801
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 48
Address:
City:
Arlington
Zip:
76015
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 3
Address:
City:
Bedford
Zip:
76021
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 43
Address:
City:
Burleson
Zip:
76028
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 25
Address:
City:
Dallas
Zip:
75208
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site32
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 7
Address:
City:
Georgetown
Zip:
78628
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 55
Address:
City:
Houston
Zip:
77027
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 40
Address:
City:
Humble
Zip:
77338
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 4
Address:
City:
McAllen
Zip:
78501
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 46
Address:
City:
San Antonio
Zip:
78224
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 18
Address:
City:
San Antonio
Zip:
78258
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 37
Address:
City:
San Antonio
Zip:
78258
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 41
Address:
City:
Bountiful
Zip:
84010
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 6
Address:
City:
Salt Lake City
Zip:
84107
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 13
Address:
City:
Suffolk
Zip:
23434
Country:
United States
Status:
Recruiting
Facility:
Name:
Endo Site 58
Address:
City:
East Maitland
Zip:
2320
Country:
Australia
Status:
Recruiting
Facility:
Name:
Endo Site 57
Address:
City:
Hunter
Zip:
2290
Country:
Australia
Status:
Recruiting
Start date:
November 28, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Endo Pharmaceuticals
Agency class:
Industry
Source:
Endo Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151197
