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Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)

10. september 2026 opdateret af: Endo USA Inc., a Keenova Therapeutics Company

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of KN3835 vs Placebo in the Treatment of Flexible/Semi-Flexible Hammertoe

The primary purpose of this study is to assess the efficacy, safety, and tolerability of KN3835 compared to placebo in the treatment of flexible/semi-flexible HMT.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

554

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Corona, California, Forenede Stater, 92882
        • Rekruttering
        • Keenova Site-009
        • Ledende efterforsker:
          • Babak Alavynejad
      • Tarzana, California, Forenede Stater, 91356
        • Rekruttering
        • Keenova Site-008
        • Ledende efterforsker:
          • Fardin Hakakian
    • Florida
      • Pinellas Park, Florida, Forenede Stater, 33782
        • Rekruttering
        • Keenova Site-004
        • Ledende efterforsker:
          • Jason Levy
      • Sweetwater, Florida, Forenede Stater, 33172
        • Rekruttering
        • Keenova Site-007
        • Ledende efterforsker:
          • Edward Gonzalez
    • Texas
      • Bedford, Texas, Forenede Stater, 76021
        • Rekruttering
        • Keenova Site-003
        • Ledende efterforsker:
          • Howard Harris
      • McAllen, Texas, Forenede Stater, 78501
        • Rekruttering
        • Keenova Site-002
        • Ledende efterforsker:
          • Joseph Caporusso
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Rekruttering
        • Keenova Site-006
        • Ledende efterforsker:
          • Clark Larsen

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Key Inclusion Criteria:

  • 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 musculoskeletal, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain.
  • Has any significant medical condition(s), which in the investigator's opinion would make the participant unsuitable for enrollment in the study.
  • Has previously participated in clinical studies of KN3835 for plantar fasciitis, plantar fibromatosis, or HMT.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Andet: Placebo
Participants will receive placebo matching to KN3835.
Eksperimentel: KN3835
Biologisk: KN3835
Participants will receive KN3835.
Andre navne:
  • EN3835

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer
Tidsramme: Baseline, Day 57
Baseline, Day 57

Sekundære resultatmål

Resultatmål
Tidsramme
Change From Baseline to Day 57 in the Foot Function Index (FFI) Difficulty Subscale Score
Tidsramme: Baseline, Day 57
Baseline, Day 57
Change From Baseline to Day 57 in the FFI Activity Limitation Subscale Score
Tidsramme: Baseline, Day 57
Baseline, Day 57
Change From Baseline to Day 57 in the Patient Global Impression of Severity (PGIS) HMT Overall Scale Score
Tidsramme: Baseline, Day 57
Baseline, Day 57
Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Percent Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Pain Subscale Score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Difficulty Subscale Score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Activity Limitation Subscale Score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Total score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Foot Pain Subscale Score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Difficulty Subscale Score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Activity Limitation Subscale Score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS HMT Overall Scale Score
Tidsramme: Baseline, up to Day 57
Baseline, up to Day 57
Number of Participants With >=1 Point Improvement in the Foot Patient Global Impression of Change (PGIC) Foot Pain Subscale Score
Tidsramme: Up to Day 57
Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Difficulty Subscale Score
Tidsramme: Up to Day 57
Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Activity Limitation Subscale Score
Tidsramme: Up to Day 57
Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC HMT Overall Scale Score
Tidsramme: Up to Day 57
Up to Day 57
Change from Baseline in the Pain Intensity Numeric Rating Scale (NRS) Score
Tidsramme: Up to Day 57
Up to Day 57
Number of Participants With >=1 Point Improvement in the Clinician Global Impression of Change (CGIC) Scale Score
Tidsramme: Up to Day 57
Up to Day 57
Number of Participants With >=1 Point Improvement in the Subject Satisfaction with Treatment Scale
Tidsramme: Up to Day 57
Up to Day 57
Number of Participants With a ≥ 30% reduction in Flexion Contracture as measured by Goniometry
Tidsramme: Baseline to Day 57
Baseline to Day 57
Number of Participants With a ≥ 50% reduction in Flexion Contracture as measured by Goniometry
Tidsramme: Baseline to Day 57
Baseline to Day 57
Number of Participants With TEAEs
Tidsramme: Baseline to Day 57
Baseline to Day 57

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

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 (Faktiske)

11. august 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

7. august 2026

Først indsendt, der opfyldte QC-kriterier

7. august 2026

Først opslået (Faktiske)

12. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • KN3835-313 HMT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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