What side effects are associated with this type of intervention?

Common treatments for Plantar Fibroma, such as collagenase enzyme injections (e.g., EN3835), can have side effects including localized pain, swelling, bruising, and potential allergic reactions at the injection site. Some patients may experience temporary weakness or numbness in the treated area. In rare cases, there may be more severe reactions such as infection or tendon rupture. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Plantar Fibroma mentioned in the provided context. However, EN3835, a collagenase enzyme that breaks down collagen in fibrous tissue, is being studied for its efficacy and safety in treating Plantar Fibromatosis. This investigational approach aims to reduce the fibrous tissue characteristic of the condition. Broadly, treatments for Plantar Fibroma may include surgical removal, steroid injections, and physical therapy, but these are not specified as FDA-approved in the context provided.

What other types of research exist?

Promising alternatives to EN3835 for Plantar Fibroma patients include: 1) Injectable treatments such as hyaluronic acid derivatives, which have shown efficacy in reducing fibrous tissue. 2) Non-surgical options like low-level laser therapy, which can help in reducing fibroma size and pain. 3) Emerging pharmacological treatments like pentoxifylline and vitamin E, which have anti-fibrotic properties. Patients should discuss these options with their healthcare provider to determine the best course of action.

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Monoclonal Antibodies

EN3835 for Plantar Fibroma

Phase 3

Waitlist Available

Research Sponsored by Endo Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (treatment 1) to treatment days 15, 29, 43, 57, 117, 197, and 237

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of EN3835, a medication for treating Plantar Fibromatosis. The study focuses on people who have already participated in a previous trial of this medication. EN3835 works by breaking down the tough tissue that forms painful lumps on the bottom of the feet.

Who is the study for?

Participants who completed a previous EN3835 study for plantar fibromatosis, haven't used opioids in the last 2 weeks, and won't change orthotics use during the trial. Women must be non-childbearing or using contraception. Excludes those with disorders affecting feet function, known allergies to collagenase or excipients of EN3835, bleeding disorders, or conditions making them unsuitable for treatment.

What is being tested?

The trial is testing the long-term safety and effectiveness of a drug called EN3835 on individuals with plantar fibromatosis who have previously received it. It will evaluate how well it works over time and if re-treatment is safe and effective.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to collagenase (the active ingredient), such as local irritation at injection sites or allergic responses among those sensitive to ingredients in EN3835.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I will not start or change my use of inserts for foot lump symptoms during the study.

Select...

I agree not to start or change my use of special shoe inserts for foot lumps during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a bleeding disorder that may affect my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (treatment 1) to treatment days 15, 29, 43, 57, 117, 197, and 237

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (treatment 1) to treatment days 15, 29, 43, 57, 117, 197, and 237

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (treatment 1) to treatment days 15, 29, 43, 57, 117, 197, and 237 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants reporting adverse events (AE)

Secondary study objectives

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

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

+19 more

Side effects data

From 2021 Phase 3 trial • 153 Patients • NCT04170296

93%

Injection site bruising

79%

Injection site pain

33%

Injection site discolouration

19%

Injection site pruritus

18%

Injection site swelling

Injection site mass

Injection site nodule

Injection site oedema

Post-inflammatory pigmentation change

Injection site haemorrhage

Oropharyngeal pain

Injection site dermatitis

Urinary tract infection

Blood potassium increased

Nitrite urine present

Pyrexia

Coronavirus test positive

Urine leukocyte esterase positive

White blood cell count increased

Diffuse alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Buttocks

Cohort 1: Posterolateral Thigh

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treated or Retreated GroupExperimental Treatment1 Intervention

Group II: Observation Only GroupActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EN3835

2019

Completed Phase 3

~1770

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Collagenase enzymes, such as EN3835, work by breaking down collagen in fibrous tissue. This is particularly relevant for Plantar Fibroma patients because the condition involves the formation of fibrous nodules in the plantar fascia, which are rich in collagen. By degrading the collagen, collagenase enzymes can reduce the size and stiffness of these nodules, potentially alleviating pain and improving foot function. This targeted approach offers a non-surgical option for managing Plantar Fibroma, which can be significant for patients seeking less invasive treatments.

Degradation of basement membrane collagens by metalloproteases released by human, murine and amphibian tumours.In vitro biological evaluation of glyburide as potential inhibitor of collagenases.Elucidation of the potential roles of matrix metalloproteinases in skeletal biology.