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NCT05254457 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Plantar Fibromatosis, sponsored by Endo Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
145
Enrollment target
20
Study locations

NCT05254457 is a Phase 3 study of Plantar Fibromatosis that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 145 participants. The trial reports 20 study locations across 9 states.

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The verdict

NCT05254457, a Phase 3 study of Plantar Fibromatosis, has completed, sponsored by Endo Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
145 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • BIOLOGICAL EN3835

Study Locations (20)

California

  • Endo Clinical Trial Site #12 - Bakersfield
  • Endo Clinical Trial Site #3 - Fresno
  • Endo Clinical Trial Site #23 - La Mesa
  • Endo Clinical Trial Site #13 - Tarzana
  • Endo Clinical Trial Site #15 - Vista
  • Endo Clinical Trial Site #18 - Whittier

Florida

  • Endo Clinical Trial Site #24 - Miami
  • Endo Clinical Trial Site #8 - Pinellas Park
  • Endo Clinical Trial Site #21 - Sweetwater

Illinois

  • Endo Clinical Trial Site #19 - Decatur
  • Endo Clinical Trial Site #2 - O'Fallon
  • Endo Clinical Trial Site #14 - Springfield

Texas

  • Endo Clinical Trial Site #4 - Bedford
  • Endo Clinical Trial Site #17 - Dallas
  • Endo Clinical Trial Site #26 - Dallas

Georgia

  • Endo Clinical Trial Site #22 - Lawrenceville

Idaho

  • Endo Clinical Trial Site #25 - Meridian

Maryland

  • Endo Clinical Trial Site #6 - Pasadena

Missouri

  • Endo Clinical Trial Site #16 - Jefferson City

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2022-02-14
Est. Completion 2024-03-21
Phase Phase 3

Sponsor

Endo Pharmaceuticals

23 total trials

What the Registry Record Tells You About NCT05254457

The ClinicalTrials.gov registry entry for NCT05254457 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Plantar Fibromatosis appearing as the primary indexed condition, and to 1 intervention - of which EN3835 is the first listed.

NCT05254457 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT05254457 about?

NCT05254457 is a clinical study titled "Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis". 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.

What is the current status of trial NCT05254457?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2022-02-14. Estimated completion is 2024-03-21.

What conditions does trial NCT05254457 study?

This clinical trial studies the following conditions: Plantar Fibromatosis.

What interventions are being tested in trial NCT05254457?

The interventions under investigation include: EN3835 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05254457?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05254457 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.