Flexible Hammertoe, Semi-flexible Hammertoe
Conditions
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.
Interventions
BIOLOGICALKN3835
Participants will receive KN3835.
OTHERPlacebo
Participants will receive placebo matching to KN3835.
Sponsors
Endo USA Inc., a Keenova Therapeutics Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer | Baseline, Day 57 |
Secondary
| 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 |
Countries
United States
Contacts
CONTACTClinical Operations
STUDY_DIRECTORMedical Director, MD
Endo USA Inc., a Keenova Therapeutics Company
Outcome results
None listed