About This Study

We understand that living with plantar fibromatosis can be painful and may interfere with daily work and family activities. Thank you for considering participating in The STRIDE Study.

In The STRIDE Study, we are evaluating an investigational drug called EN3835 for the treatment of plantar fibromatosis nodules. “Investigational” means that it has not been approved for use and that its safety and effectiveness are still being studied. Before new medications can be approved for public use, they must be tested in research studies like this one.

The STRIDE Study will last up to about 113 days, and participants will have 7 scheduled study center visits. After potential participants have learned about the study and signed an Informed Consent Form confirming this and their willingness to join the study, they will be screened to see if they meet the qualifications to participate.

What to Expect

• The study center staff will talk with people who are interested in participating in this research study.
• If the study staff feels an interested person may qualify to participate, the study staff will give a detailed explanation of this study and its potential risks and benefits.
• If the person continues to be interested in the study, the study doctor and staff will review the person’s medical history and conduct several tests to determine whether the potential participant will satisfy all study entry requirements.

Participation Costs

There is no cost to participate, receive the investigational drug, visit the study center, or undergo study-related procedures, tests, and exams. Participants who meet study requirements may be compensated for study-related time and expenses.

Living With
Plantar Fibromatosis
Can Be Painful...

Those who qualify to be in the study will be assigned to receive either EN3835 or a placebo, a substance with no active ingredients. This assignment is randomly performed by a computer and neither study personnel nor the participant will know which they have received. The chance of being in either group is 50/50, like flipping a coin.

Qualified participants will return to the study center for a Treatment visit at which the investigational drug or placebo will be given. Participants will complete daily pain questionnaires on an electronic diary, or “e-diary.” Participants will be trained how to use the e-diary and how to rate their pain.

About one month after the first treatment, participants who have plantar fibromatosis nodules that continue to satisfy study criteria will receive a second study treatment. Participants will continue to complete daily pain questionnaires until the End of Study Visit, approximately 85 days after the first study treatment was administered.