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Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
RecruitingPhase 3
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
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- KN3835 (biological)
- Placebo (other)
Sponsor: Endo USA Inc., a Keenova Therapeutics Company · Participants: 554 · Started: Aug 11, 2026
Contact the study team
- Clinical Operations · Phone: 800-462-3636
Official record on ClinicalTrials.gov — NCT07759362
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.