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NCT07759362PHASE3Recruiting

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

Endo USA Inc., a Keenova Therapeutics Company

Start Date

8/11/2026

Completion Date

12/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

BIOLOGICAL

KN3835

OTHER

Placebo

Interested in This Trial?

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Conditions

Flexible HammertoeSemi-flexible Hammertoe

Locations

Keenova Site-009

Corona, California 92882

United States

Keenova Site-008

Tarzana, California 91356

United States

Keenova Site-004

Pinellas Park, Florida 33782

United States

Keenova Site-007

Sweetwater, Florida 33172

United States

Keenova Site-003

Bedford, Texas 76021

United States

Keenova Site-002

McAllen, Texas 78501

United States

Keenova Site-006

Salt Lake City, Utah 84107

United States