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

Phase 3RecruitingNCT07759362

Endo USA Inc., a Keenova Therapeutics Company554 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

554

Conditions

Flexible Hammertoe Semi-flexible Hammertoe

Interventions

KN3835BIOLOGICAL

Participants will receive KN3835.

PlaceboOTHER

Participants will receive placebo matching to KN3835.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (7)

Keenova Site-009

Corona, California, United States

RECRUITING

Keenova Site-008

Tarzana, California, United States

RECRUITING

Keenova Site-004

Pinellas Park, Florida, United States

Outcomes

Primary Outcomes

Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer

Time frame: Baseline, Day 57

Secondary Outcomes

Change From Baseline to Day 57 in the Foot Function Index (FFI) Difficulty Subscale Score

Time frame: Baseline, Day 57

Change From Baseline to Day 57 in the FFI Activity Limitation Subscale Score

Time frame: Baseline, Day 57

Change From Baseline to Day 57 in the Patient Global Impression of Severity (PGIS) HMT Overall Scale Score

Time frame: Baseline, Day 57

Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer