NCT05152173

Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis

Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis.

Conditions

• Plantar Fibromatosis

Interventions

Type	Name	Description
BIOLOGICAL	EN3835	Participant will receive a maximum dose of up to1.8mg of EN3835 injection
OTHER	Placebo	Participant will receive a matched Placebo injection

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-01-10
• Completion: 2023-01-10
• First posted: 2021-12-09
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

43 sites across 1 country: United States

Regulatory

• FDA-regulated drug study