EN3835-309 PFI STRIDE is a clinical trial of an investigational drug in adults living with plantar fibromatosis (PFI). Despite treatments for symptom relief there is no drug to treat the disease itself.

What is EN3835-309 PFI STRIDE?

EN3835-309 PFI STRIDE will evaluate whether an investigational drug, EN3835, can help reduce the pain associated with PFI. The study will also assess the investigational drug’s efficacy, safety, and tolerability.

The study includes a 28-day screening period to determine eligibility and once enrolled, you will be in the study for up to 85 days. The study includes a maximum of two treatment visits (on Day 1 and possibly Day 29), and four to five follow-up clinic visits. During the treatment period, participants will be randomized (as if by the toss of a coin) to receive either the investigational drug or placebo (placebo looks like the study drug but contains no active ingredients).

During the treatment day(s) at the study site, all participants will receive 1 to 2 injections of EN3835 or placebo for each PFI nodule. The number of injections depends upon the size of your nodules. You will be encouraged to resume all daily activities, including walking, and bearing weight on the treated foot.

About 418 participants are expected to participate in the study.

Who is eligible to participate?

You may be able to join EN3835-309 PFI STRIDE if you:

• Are at least 18 years of age
• Have been diagnosed with PFI and have ≤2 nodules on your foot
• Have current foot pain due to PFI

There are other requirements for taking part in EN3835-309 PFI STRIDE. I would welcome the chance to talk with you about the study to see if you may qualify.

Why should you take part in this study?

Participation is voluntary. Deciding to discontinue the study after enrolling will not affect your usual medical care now or in the future. There is no guarantee that you will directly benefit from taking part, but you may help advance knowledge about treating PFI. All participants will receive closely monitored medical care from a study doctor throughout their participation in EN3835-309 PFI STRIDE.

What should you do if you are interested?

Please contact us if you would like to learn more about EN3835-309 PFI STRIDE. We will be happy to discuss the study details, your options, and the risks and benefits of taking part in the trial.

Trisha Bernardin, Study Coordinator
Phone: 904-244-9694
Email: Trisha.Bernardin@jax.ufl.edu

Dr. Jason Piraino, Principal Investigator
Phone: 904-244-5942
Email: Jason.Piraino@jax.ufl.edu