Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New shot could ease pain of rare foot condition

NCT ID NCT06151197

Symptom relief Sponsor: Endo USA Inc., a Keenova Therapeutics Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This phase 3 study tests an injection called EN3835 against a placebo for people with Ledderhose disease, which causes painful lumps on the soles of the feet. About 418 adults with foot pain from this condition will receive either the drug or a placebo. The main goal is to see if EN3835 reduces daily foot pain and improves function over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EN3835 (a biologic injection)
What this could lead to
If it works, this could provide a non-surgical treatment option to reduce foot pain and improve daily function for people with Ledderhose disease.
What could go wrong
This is a late-stage trial, but the treatment may not work better than placebo. Possible injection-site reactions or lack of long-term benefit are risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

436 people

The number who actually took part.

Started

Nov 2023

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ledderhose disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Fibromatosis, Plantar plantar fibromatosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ledderhose disease Plantar fibromatosis

Contacts and locations

Locations

  • Endo Clinical Site 1

    Pinellas Park, Florida, 33782, United States

  • Endo Clinical Site 2

    Encinitas, California, 92024, United States

  • Endo Site 10

    Altoona, Pennsylvania, 16602, United States

  • Endo Site 11

    Tucson, Arizona, 85712, United States

  • Endo Site 12

    Jefferson City, Missouri, 65109, United States

  • Endo Site 13

    Suffolk, Virginia, 23434, United States

  • Endo Site 14

    Plantation, Florida, 33317, United States

  • Endo Site 15

    Durham, North Carolina, 27704, United States

  • Endo Site 16

    Grand Rapids, Michigan, 49525, United States

  • Endo Site 17

    Westminster, Colorado, 80031, United States

  • Endo Site 18

    San Antonio, Texas, 78251, United States

  • Endo Site 19

    Palm Beach Gardens, Florida, 33410, United States

  • Endo Site 20

    Wilmington, North Carolina, 28412, United States

  • Endo Site 21

    Miami, Florida, 33184, United States

  • Endo Site 22

    Hialeah, Florida, 33013, United States

  • Endo Site 23

    Miami, Florida, 33126, United States

  • Endo Site 24

    Lawrenceville, Georgia, 30043, United States

  • Endo Site 25

    Dallas, Texas, 75208, United States

  • Endo Site 26

    Miami, Florida, 33156, United States

  • Endo Site 27

    O'Fallon, Illinois, 62269, United States

  • Endo Site 28

    Lancaster, California, 93534, United States

  • Endo Site 29

    Sherman Oaks, California, 91403, United States

  • Endo Site 3

    Bedford, Texas, 76021, United States

  • Endo Site 30

    Tarzana, California, 91356, United States

  • Endo Site 31

    Corona, California, 92882, United States

  • Endo Site 33

    Virginia Gardens, Florida, 33166, United States

  • Endo Site 34

    Oradell, New Jersey, 07649, United States

  • Endo Site 35

    North Miami Beach, Florida, 33169, United States

  • Endo Site 36

    Missoula, Montana, 59804, United States

  • Endo Site 37

    San Antonio, Texas, 78258, United States

  • Endo Site 38

    State College, Pennsylvania, 16801, United States

  • Endo Site 39

    Cerritos, California, 90703, United States

  • Endo Site 4

    McAllen, Texas, 78501, United States

  • Endo Site 40

    Humble, Texas, 77338, United States

  • Endo Site 41

    Bountiful, Utah, 84010, United States

  • Endo Site 42

    Mesa, Arizona, 85210, United States

  • Endo Site 43

    Burleson, Texas, 76028, United States

  • Endo Site 44

    Malvern, Pennsylvania, 19355, United States

  • Endo Site 45

    Oak Brook, Illinois, 60523, United States

  • Endo Site 46

    San Antonio, Texas, 78224, United States

  • Endo Site 47

    Johnstown, Colorado, 80534, United States

  • Endo Site 48

    Arlington, Texas, 76015, United States

  • Endo Site 49

    Castro Valley, California, 94546, United States

  • Endo Site 5

    Pasadena, Maryland, 21122, United States

  • Endo Site 50

    San Francisco, California, 94115, United States

  • Endo Site 51

    Billings, Montana, 59101, United States

  • Endo Site 52

    Falls Church, Virginia, 22042, United States

  • Endo Site 53

    Los Angeles, California, 90063, United States

  • Endo Site 54

    Overland Park, Kansas, 66211, United States

  • Endo Site 55

    Houston, Texas, 77027, United States

  • Endo Site 56

    Shreveport, Louisiana, 71101, United States

  • Endo Site 59

    Jacksonville, Florida, 32209, United States

  • Endo Site 6

    Salt Lake City, Utah, 84107, United States

  • Endo Site 60

    Sweetwater, Florida, 33172, United States

  • Endo Site 61

    Torrance, California, 90502, United States

  • Endo Site 62

    Vineland, New Jersey, 08360, United States

  • Endo Site 63

    Oklahoma City, Oklahoma, 73102, United States

  • Endo Site 64

    Scottsdale, Arizona, 85260, United States

  • Endo Site 65

    Parker, Colorado, 80134, United States

  • Endo Site 68

    Mayagüez, 00682, Puerto Rico

  • Endo Site 69

    Ponce, 00716, Puerto Rico

  • Endo Site 7

    Georgetown, Texas, 78628, United States

  • Endo Site 70

    Mayagüez, 00680, Puerto Rico

  • Endo Site 8

    Fresno, California, 93710, United States

  • Endo Site 9

    Los Angeles, California, 90010, United States

  • Endo Site32

    Fort Worth, Texas, 76104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.