NCT07759362 · Endo USA Inc., a Keenova Therapeutics Company
Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
What this study is about
The primary purpose of this study is to assess the effectiveness, safety, and tolerability of KN3835 compared to placebo in the treatment of flexible/semi-flexible HMT.
View original scientific description
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.
Interventions
BIOLOGICAL
KN3835
Participants will receive KN3835.
OTHER
Placebo
Participants will receive placebo matching to KN3835.
Primary outcome measures
Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer
Time frame: Baseline, Day 57
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Corona, California
- Tarzana, California
- Pinellas Park, Florida
- Sweetwater, Florida
- Bedford, Texas
- McAllen, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations