EN3835 for Plantar Fibromatosis

(STRIDE Trial)

Recruiting at 70 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Endo Pharmaceuticals

Disqualifiers: Non-PFI nodules, Neurological disorders, Bleeding disorders, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

418 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot use any medication to treat PFI pain unless allowed by the study. It's best to discuss your specific medications with the study team.

Is collagenase clostridium histolyticum (CCH) safe for humans?

Collagenase clostridium histolyticum (CCH), also known as Xiaflex, has been studied for safety in conditions like Peyronie's disease and Dupuytren's contracture. These studies generally support its safety, although specific risks may vary depending on the condition being treated. ^{1 2 3 4 5}

How is the drug EN3835 (XIAFLEX) unique for treating plantar fibromatosis?

EN3835, also known as XIAFLEX, is unique because it is an injectable treatment that uses enzymes to break down collagen, which is a protein that can cause thickening and hardening in tissues. This approach is different from traditional surgical methods and has been used effectively for conditions like Dupuytren's contracture and Peyronie's disease, where it helps to reduce tissue buildup without surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Luis Ortega

Principal Investigator

Endo Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Ledderhose disease, which causes painful foot lumps. Participants must be able to walk and give informed consent. Women must either not be able to have children or agree to use birth control during the study.

Inclusion Criteria

I have been diagnosed with primary fibromyalgia.

I have foot pain because of plantar fasciitis.

I am not able to have children, or I agree to use birth control during and after the study.

Exclusion Criteria

Is pregnant or plans to become pregnant

Is breastfeeding or is providing or plans to provide breast milk in any manner during the study

I have lumps on my foot not related to plantar fibromatosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EN3835 or placebo to assess efficacy, safety, and tolerability in the treatment of Plantar Fibromatosis

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EN3835

Trial Overview The trial is testing EN3835's effectiveness against a placebo in treating Ledderhose disease. It aims to see if EN3835 can reduce pain and improve condition without causing harm.

How Is the Trial Designed?

Group I: EN3835 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

EN3835 is already approved in United States for the following indications:

Approved in United States as XIAFLEX for:

• Dupuytren's contracture
• Peyronie's disease

Who Is Running the Clinical Trial?

Endo Pharmaceuticals

Lead Sponsor

Trials

136

Recruited

33,700+

Matthew Davis

Endo Pharmaceuticals

Chief Medical Officer since 2016

MD

Scott Hirsch

Endo Pharmaceuticals

Chief Executive Officer

BA in Economics from Princeton University

Published Research Related to This Trial

In a phase 3 study involving 347 men with Peyronie's disease, collagenase clostridium histolyticum (CCH) demonstrated a significant mean improvement of 34.4% in penile curvature deformity and a reduction of 3.3 points in the PD symptom bother score after 36 weeks of treatment.

CCH was generally well tolerated, with most adverse events being mild or moderate, and only three serious treatment-related adverse events were reported, all of which resolved with treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. Levine, LA., Cuzin, B., Mark, S., et al.[2022]

In a study of 197 patients receiving collagenase clostridium histolyticum injections for Dupuytren contracture, 52% were on anticoagulation therapy, primarily aspirin, and the procedure showed no significant increase in complications compared to nonanticoagulated patients.

The study found that it is safe to perform collagenase injections in patients on anticoagulants, as there were no significant differences in complications like skin tears or tendon ruptures, indicating that anticoagulation does not adversely affect the safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Anticoagulation on the Treatment of Dupuytren Contracture with Collagenase. Noland, SS., Paul, AW., Pflibsen, LR., et al.[2022]

In a post-hoc analysis of 362 patients from two pivotal phase 3 trials, 82% of patients with Dupuytren's contracture and moderate disease achieved clinical success after treatment with collagenase clostridium histolyticum (CCH), indicating its efficacy in this specific population.

CCH was well tolerated, with mild to moderate adverse events reported and no discontinuations due to side effects, suggesting a favorable safety profile for patients with up to two joints affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of collagenase clostridium histolyticum in the treatment of patients with moderate Dupuytren's contracture. McGrouther, DA., Jenkins, A., Brown, S., et al.[2018]

In a study of 788 patients treated with Xiapex® for Dupuytren's disease, 66.5% experienced a significant reduction in contracture, demonstrating the efficacy of the treatment.

The safety profile of Xiapex® was favorable, with no major complications reported and only minor adverse events, such as skin tears (26%), which resolved within 30 days; only 2% of patients required surgical intervention within a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren's disease in 788 patients: the Austrian register. Rohit, A., Peter, A., Paul, A., et al.[2020]

In a study involving 66 patients with Dupuytren's contracture, collagenase clostridium histolyticum (Xiaflex) was found to be significantly more effective than placebo, with 44.4% of treated cords achieving a reduction in contracture to 0° to 5° compared to only 4.8% in the placebo group.

Collagenase treatment resulted in a mean decrease in joint contracture of 70.5% and a significant increase in range of motion, demonstrating its efficacy as a well-tolerated, nonsurgical option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. Gilpin, D., Coleman, S., Hall, S., et al.[2022]

In a study of 49 patients with Peyronie's disease, collagenase Clostridium histolyticum (CCh) treatment significantly reduced penile curvature by an average of 15.4 degrees (32.4%), improving the ability to perform intercourse by 29.1%.

While CCh showed promising results in reducing curvature and improving subjective symptoms, there were some safety concerns, including a 10.2% incidence of notable bleeding events, with one case resulting in a penile fracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peyronie's Disease and Injectable Collagenase Clostridium histolyticum: Safety, Efficacy, and Improvements in Subjective Symptoms. Yang, KK., Bennett, N.[2022]

In a study involving 31 patients with Peyronie's disease, a modified treatment protocol using collagenase Clostridium histolyticum (CCH) resulted in an 80.6% improvement in curvature, with an average reduction of 20.65 degrees, demonstrating its efficacy.

The modified protocol was found to be safe, as no treatment-related adverse events were reported, suggesting it could be a viable alternative to the standard, more resource-intensive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of collagenase Clostridium histolyticum in Peyronie's disease following a modified treatment protocol. García Cruz, E., Mercader Barrull, C., Camacho Rovira, D., et al.[2021]

Collagenase clostridium histolyticum (CCH) is a safe and effective FDA-approved treatment for Dupuytren's contracture, with a low rate of serious adverse events (0.6% per 1,000 injections) reported in the first year after its approval.

The most common adverse events were minor, including local reactions like skin tears and peripheral edema, confirming the safety profile established in earlier clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsurgical treatment of Dupuytren's contracture: 1-year US post-marketing safety data for collagenase clostridium histolyticum. Peimer, CA., McGoldrick, CA., Fiore, GJ.[2021]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Anticoagulation on the Treatment of Dupuytren Contracture with Collagenase. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of collagenase clostridium histolyticum in the treatment of patients with moderate Dupuytren's contracture. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren's disease in 788 patients: the Austrian register. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Peyronie's Disease and Injectable Collagenase Clostridium histolyticum: Safety, Efficacy, and Improvements in Subjective Symptoms. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Efficacy and safety of collagenase Clostridium histolyticum in Peyronie's disease following a modified treatment protocol. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Nonsurgical treatment of Dupuytren's contracture: 1-year US post-marketing safety data for collagenase clostridium histolyticum. [2021]