Trials / Active Not Recruiting
Active Not RecruitingNCT06151197
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (estimated)
- Sponsor
- Endo Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EN3835 | Biologic: EN3835 injection |
| OTHER | Placebo | Placebo injection |
Timeline
- Start date
- 2023-11-28
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2023-11-30
- Last updated
- 2026-03-13
Locations
66 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06151197. Inclusion in this directory is not an endorsement.