Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
23. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
470
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Clinical Operations
- Telefonnummer: 800-462-3636
- E-post: clinicaltrials@endo.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Participants will receive KN3835 in Part 2 of the Study
Andre navn:
|
|
Ingen inngripen: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants with Adverse Events
Tidsramme: Observational Day 1 up to Treatment/Retreatment Period Day 360
|
Observational Day 1 up to Treatment/Retreatment Period Day 360
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to Observational Day 360
|
Up to Observational Day 360
|
|
Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to Treatment/Retreatment Period Day 360
|
Up to Treatment/Retreatment Period Day 360
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
11. oktober 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
23. september 2026
Først innsendt som oppfylte QC-kriteriene
23. september 2026
Først lagt ut (Faktiske)
29. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- KN3835-314 HMT
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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