Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
Endo USA Inc., a Keenova Therapeutics Company · NCT07759362
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 554
- US sites recruiting
- 7
- Study start
- August 11, 2026
- Record last updated
- September 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: KN3835; Placebo
Conditions: Flexible Hammertoe; Semi-flexible Hammertoe
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Keenova Site-009
Corona, CA 92882
Site contact: Babak Alavynejad
Keenova Site-008
Tarzana, CA 91356
Site contact: Fardin Hakakian
Keenova Site-004
Pinellas Park, FL 33782
Site contact: Jason Levy
Keenova Site-007
Sweetwater, FL 33172
Site contact: Edward Gonzalez
Keenova Site-003
Bedford, TX 76021
Site contact: Howard Harris
Keenova Site-002
McAllen, TX 78501
Site contact: Joseph Caporusso
Keenova Site-006
Salt Lake City, UT 84107
Site contact: Clark Larsen
Study contacts (from the official record)
- Clinical Operations · 800-462-3636 · clinicaltrials@endo.com