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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 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Estimé)

470

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: KN3835

Participants will receive KN3835 in Part 2 of the Study

Autres noms:
  • EN3835
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Number of Participants with Adverse Events
Délai: Observational Day 1 up to Treatment/Retreatment Period Day 360
Observational Day 1 up to Treatment/Retreatment Period Day 360

Mesures de résultats secondaires

Mesure des résultats
Délai
Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to Observational Day 360
Up to Observational Day 360
Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to Treatment/Retreatment Period Day 360
Up to Treatment/Retreatment Period Day 360

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Endo USA Inc., a Keenova Therapeutics Company

Les enquêteurs

  • Directeur d'études: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

11 octobre 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

23 septembre 2026

Première soumission répondant aux critères de contrôle qualité

23 septembre 2026

Première publication (Réel)

29 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • KN3835-314 HMT

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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