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Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis

NCT05254457 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-03-21

No results posted yet for this study

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

  • Plantar Fibromatosis

Interventions

BIOLOGICAL

EN3835

Treatment or retreatment with EN3835

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Nina Green · Endo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2024-03-21
Completion
2024-03-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254457 on ClinicalTrials.gov