Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
23. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret 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).
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
470
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Clinical Operations
- Telefonnummer: 800-462-3636
- E-mail: clinicaltrials@endo.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
|
|
Ingen indgriben: 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. |
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
11. oktober 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
23. september 2026
Først indsendt, der opfyldte QC-kriterier
23. september 2026
Først opslået (Faktiske)
29. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KN3835-314 HMT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ja
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Ingen
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