Recruiting
Phase 3

KN3835

Sponsor:

Endo USA Inc., a Keenova Therapeutics Company

Code:

NCT07759362

Conditions

Flexible Hammertoe

Semi-flexible Hammertoe

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KN3835

Placebo

Study Details

Brief 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.

Conditions

Flexible Hammertoe

Semi-flexible Hammertoe

Study ID

NCT07759362

Start date

Aug 11, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

554 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KN3835

placebo comparator: Placebo

Interventions

KN3835

Participants will receive KN3835.

Placebo

Participants will receive placebo matching to KN3835.

Primary outcome measure

  • Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer [ Time Frame: Baseline, Day 57 ]

Central Contacts and Locations

Central contacts

Clinical Operations

800-462-3636clinicaltrials@endo.com

Locations

Keenova Site-009

Recruiting

Corona, California, United States, 92882

Principal Investigator:

Babak Alavynejad

Keenova Site-008

Recruiting

Tarzana, California, United States, 91356

Principal Investigator:

Fardin Hakakian

Keenova Site-004

Recruiting

Pinellas Park, Florida, United States, 33782

Principal Investigator:

Jason Levy

Keenova Site-007

Recruiting

Sweetwater, Florida, United States, 33172

Principal Investigator:

Edward Gonzalez

Keenova Site-003

Recruiting

Bedford, Texas, United States, 76021

Principal Investigator:

Howard Harris

Keenova Site-002

Recruiting

McAllen, Texas, United States, 78501

Principal Investigator:

Joseph Caporusso

Keenova Site-006

Recruiting

Salt Lake City, Utah, United States, 84107

Principal Investigator:

Clark Larsen

More Information

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Endo USA Inc., a Keenova Therapeutics Company on 2026-09-14.