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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.
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
Study Summary
This trial will study the long-term effects of a drug called EN3835 on people who have previously taken it for Plantar Fibromatosis, as well as its effects on treating and re-treating the condition.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants reporting adverse events (AE)
Secondary outcome measures
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 moreSide effects data
From 2021 Phase 3 trial • 153 Patients • NCT0417029693%
Injection site bruising
79%
Injection site pain
33%
Injection site discolouration
19%
Injection site pruritus
18%
Injection site swelling
7%
Injection site oedema
7%
Injection site nodule
7%
Injection site mass
3%
Injection site haemorrhage
3%
Post-inflammatory pigmentation change
1%
Diffuse alopecia
1%
Urinary tract infection
1%
Coronavirus test positive
1%
Blood potassium increased
1%
White blood cell count increased
1%
Nitrite urine present
1%
Urine leukocyte esterase positive
1%
Oropharyngeal pain
1%
Injection site dermatitis
1%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Buttocks
Cohort 1: Posterolateral Thigh
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
~1540
Find a Location
Who is running the clinical trial?
Endo PharmaceuticalsLead Sponsor
133 Previous Clinical Trials
34,851 Total Patients Enrolled
Nina GreenStudy DirectorEndo Pharmaceuticals
1 Previous Clinical Trials
177 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I will not start or change my use of inserts for foot lump symptoms during the study.I am a woman not able to have children or will use birth control during the study.You are willing and able to comply with all protocol required visits and assessments.I am not able to have children, or I agree to use birth control during and after the study.I agree not to start or change my use of special shoe inserts for foot lumps during the study.I have a bleeding disorder that may affect my treatment.My foot nodules may not be suitable for EN3835 treatment according to my doctor.I have had or plan to have treatment on my foot or its nodules.You are allergic to collagenase or any other ingredients in EN3835.I have a condition affecting my feet or nerves that could interfere with study tasks.My foot nodules have no significant medical issues that would prevent me from taking EN3835.My foot nodules have no significant medical issues that would prevent me from taking EN3835.I understand the study's risks and can give my consent.I have a bleeding disorder or take medication that increases bleeding risk, but I don't take more than 150mg of aspirin daily.
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treated or Retreated Group
- Group 2: Observation Only Group
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a high mortality rate associated with EN3835?
"EN3835 has undergone Phase 3 clinical trials, so there is some evidence of its efficacy and multiple reports supporting its safety. Therefore, it has been given a score of 3 for safety."
Answered by AI
Who else is applying?
What state do they live in?
California
Georgia
How old are they?
18 - 65
65+
What site did they apply to?
Endo Clinical Trial Site #1
Endo Clinical Trial Site #15
Endo Clinical Trial Site #7
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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