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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Flexible Hammertoe; Semi-flexible Hammertoe
• Intervention / Treatment: Biological: KN3835; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 554
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Operations; Phone Number: 800-462-3636; Email: clinicaltrials@endo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Participants will receive placebo matching to KN3835.
Experimental: KN3835	Biological: KN3835; Participants will receive KN3835.; Other Names: EN3835

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer	Baseline, Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline to Day 57 in the Foot Function Index (FFI) Difficulty Subscale Score	Baseline, Day 57
Change From Baseline to Day 57 in the FFI Activity Limitation Subscale Score	Baseline, Day 57
Change From Baseline to Day 57 in the Patient Global Impression of Severity (PGIS) HMT Overall Scale Score	Baseline, Day 57
Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer	Baseline, up to Day 57
Percent Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer	Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Pain Subscale Score	Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Difficulty Subscale Score	Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Activity Limitation Subscale Score	Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Total score	Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Foot Pain Subscale Score	Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Difficulty Subscale Score	Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Activity Limitation Subscale Score	Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS HMT Overall Scale Score	Baseline, up to Day 57
Number of Participants With >=1 Point Improvement in the Foot Patient Global Impression of Change (PGIC) Foot Pain Subscale Score	Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Difficulty Subscale Score	Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Activity Limitation Subscale Score	Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC HMT Overall Scale Score	Up to Day 57
Change from Baseline in the Pain Intensity Numeric Rating Scale (NRS) Score	Up to Day 57
Number of Participants With >=1 Point Improvement in the Clinician Global Impression of Change (CGIC) Scale Score	Up to Day 57
Number of Participants With >=1 Point Improvement in the Subject Satisfaction with Treatment Scale	Up to Day 57
Number of Participants With a ≥ 30% reduction in Flexion Contracture as measured by Goniometry	Baseline to Day 57
Number of Participants With a ≥ 50% reduction in Flexion Contracture as measured by Goniometry	Baseline to Day 57
Number of Participants With TEAEs	Baseline to Day 57

Collaborators and Investigators

• Sponsor: Endo USA Inc., a Keenova Therapeutics Company
• Investigators: Study Director: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 7, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KN3835-313 HMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes