Trials / Completed
CompletedNCT05254457
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
A Multi-Center, Open-Label, Extension Study to Evaluate the Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- Endo Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of EN3835 in the treatment and retreatment of plantar fibromatosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EN3835 | Treatment or retreatment with EN3835 |
Timeline
- Start date
- 2022-02-14
- Primary completion
- 2024-03-21
- Completion
- 2024-03-21
- First posted
- 2022-02-24
- Last updated
- 2025-03-21
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05254457. Inclusion in this directory is not an endorsement.