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Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)

23 september 2026 bijgewerkt door: Endo USA Inc., a Keenova Therapeutics Company

A Phase 3, Multi-center Extension Study to Evaluate the Long-term Safety, Efficacy, and Maintenance of Response of KN3835 in the Treatment and Retreatment of Flexible/Semi-flexible Hammertoe

The primary purpose of this study is to assess the long-term safety of treatment and retreatment with KN3835 for flexible/semi-flexible HMT.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This extension study is for eligible participants who completed parent study KN3835-313 HMT. The study comprises 2 parts:

  • Part I: a double-blind Observation Period from Observational Day 1 to Observational Day 360, and
  • Part 2: an optional open-label Treatment/Retreatment Period from Observational Day 180 (Treatment/Retreatment Day 1) to Treatment/Retreatment Day 360 (End of Study).

Studietype

Ingrijpend

Inschrijving (Geschat)

470

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Were enrolled in and completed Study KN3835-313 (participants who completed the study are those that completed the Day 57/End of Study Visit, were assessed for safety, and received at least 1 dose of study intervention).
  • Has no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration or study required evaluations.
  • If female, be of non-childbearing potential or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after treatment.
  • Be willing and able to comply with all protocol required visits and assessments.

Key Exclusion Criteria:

  • Has any significant medical condition, or a serious or severe event in the parent study or any ongoing event from the parent study, which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
  • Has received or plans to receive surgical or nonsurgical treatments on the foot or toe that was treated for the duration of study participation.

Note: Other inclusion/exclusion criteria may apply.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Observation then KN3835

After observation during Part 1 of the study, participants will have the option to receive treatment or retreatment with KN3835 in Part 2.
Biologisch: KN3835

Participants will receive KN3835 in Part 2 of the Study

Andere namen:
  • EN3835
Geen tussenkomst: Observation Only

Participants will be observed through Part 1. After completion of Part 1, participants will have the option to be observed only during Part 2 of the study.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Number of Participants with Adverse Events
Tijdsspanne: Observational Day 1 up to Treatment/Retreatment Period Day 360
Observational Day 1 up to Treatment/Retreatment Period Day 360

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period
Tijdsspanne: Baseline and up to Observational Day 360
Baseline and up to Observational Day 360
Change from Baseline In FFI Subscales (Difficulty, Pain and Activity Limitation) Scores In Part 1 Observational Period
Tijdsspanne: Baseline and up to Observational Day 360
Baseline and up to Observational Day 360
Change from Baseline In Pain Intensity Numeric Rating Scale (NRS) Score In Part 1 Observational Period
Tijdsspanne: Baseline and up to Observational Day 360
Baseline and up to Observational Day 360
Percentage of Participants That Meet Retreatment/Treatment Criteria In Part 1 Observational Period
Tijdsspanne: Observational Day 180
Observational Day 180
Percentage of Participants Reporting To Be "Quite Satisfied" and "Very Satisfied" On The Subject Satisfaction With Treatment Scale In Part 1 Observational Period
Tijdsspanne: Up to Observational Day 360
Up to Observational Day 360
Percentage Participants with Investigator Reported "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the Clinician Global Impression of Change Scale (CGIC) Scale Score in Part 1 Observational Period
Tijdsspanne: Up to Observational Day 360
Up to Observational Day 360
Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period
Tijdsspanne: Baseline and up to Observational Day 360
Baseline and up to Observational Day 360
Percent Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period
Tijdsspanne: Baseline and up to Observational Day 360
Baseline and up to Observational Day 360
Change from Baseline In The Patient Global Impression of Severity (PGIS) HMT Overall Scale Score in Part 1 Observational Period
Tijdsspanne: Baseline and up to Observational Day 360
Baseline and up to Observational Day 360
Percentage Of Participants reporting "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the Patient Global Impression of Change Scale (PGIC) HMT Overall Scale Score in Part 1 Observational Period
Tijdsspanne: Up to Observational Day 360
Up to Observational Day 360
Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period
Tijdsspanne: Baseline and up to Treatment/Retreatment Period Day 360
Baseline and up to Treatment/Retreatment Period Day 360
Change from Baseline In FFI Subscales (Difficulty, Pain and Activity Limitation) Scores In Part 2 Treatment/Retreatment Period
Tijdsspanne: Baseline and up to Treatment/Retreatment Period Day 360
Baseline and up to Treatment/Retreatment Period Day 360
Change from Baseline In Pain Intensity NRS Score In Part 2 Treatment/Retreatment Period
Tijdsspanne: Baseline and up to Treatment/Retreatment Period Day 360
Baseline and up to Treatment/Retreatment Period Day 360
Percentage of Participants Reporting To Be "Satisfied" and "Very Satisfied" On The Subject Satisfaction With Treatment Scale In Part 2 Treatment/Retreatment Period
Tijdsspanne: Up to Treatment/Retreatment Period Day 360
Up to Treatment/Retreatment Period Day 360
Percentage Of Participants with Investigator Reported "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the CGIC HMT Overall Scale Score in Part 2 Treatment/Retreatment Period
Tijdsspanne: Up to Treatment/Retreatment Period Day 360
Up to Treatment/Retreatment Period Day 360
Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 2 Treatment/Retreatment Period
Tijdsspanne: Baseline and up to Treatment/Retreatment Period Day 360
Baseline and up to Treatment/Retreatment Period Day 360
Percent Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 2 Treatment/Retreatment Period
Tijdsspanne: Baseline and up to Treatment/Retreatment Period Day 360
Baseline and up to Treatment/Retreatment Period Day 360
Change from Baseline In The PGIS HMT Overall Scale Score in Part 2 Treatment/Retreatment Period
Tijdsspanne: Baseline and up to Treatment/Retreatment Period Day 360
Baseline and up to Treatment/Retreatment Period Day 360
Percentage Of Participants reporting "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the PGIC HMT Overall Scale Score in Part 2 Treatment/Retreatment Period
Tijdsspanne: Up to Treatment/Retreatment Period Day 360
Up to Treatment/Retreatment Period Day 360

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Onderzoekers

  • Studie directeur: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

11 oktober 2026

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

23 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 september 2026

Eerst geplaatst (Werkelijk)

29 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 september 2026

Laatste update ingediend die voldeed aan QC-criteria

23 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • KN3835-314 HMT

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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