Flexible HammertoePhase 3NCT07759362
Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
A Phase 3 study testing KN3835 in people with Flexible Hammertoe and Semi-flexible Hammertoe, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Flexible Hammertoe, Semi-flexible Hammertoe
- What is being tested?
- KN3835
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 554 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Aug 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Keenova Site-003
Bedford, Texas, 76021
Howard Harris
- Recruiting
Keenova Site-009
Corona, California, 92882
Babak Alavynejad
- Recruiting
Keenova Site-002
McAllen, Texas, 78501
Joseph Caporusso
- Recruiting
Keenova Site-004
Pinellas Park, Florida, 33782
Jason Levy
- Recruiting
Keenova Site-006
Salt Lake City, Utah, 84107
Clark Larsen
- Recruiting
Keenova Site-007
Sweetwater, Florida, 33172
Edward Gonzalez
- Recruiting
Keenova Site-008
Tarzana, California, 91356
Fardin Hakakian
About this study
Official title: 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.
- Conditions
- Flexible Hammertoe, Semi-flexible Hammertoe
- Being tested
- KN3835, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN3835Biological
Also called EN3835
Participants will receive KN3835.
PlaceboOther
Participants will receive placebo matching to KN3835.
| Study group | Role | What they receive |
|---|---|---|
| KN3835 | Experimental | Not described Receives: Biological: KN3835 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer
Measured: Baseline, Day 57
Secondary outcomes (23)
Change From Baseline to Day 57 in the Foot Function Index (FFI) Difficulty Subscale Score
Measured: Baseline, Day 57
Change From Baseline to Day 57 in the FFI Activity Limitation Subscale Score
Measured: Baseline, Day 57
Change From Baseline to Day 57 in the Patient Global Impression of Severity (PGIS) HMT Overall Scale Score
Measured: Baseline, Day 57
Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer
Measured: Baseline, up to Day 57
Percent Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer
Measured: Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Pain Subscale Score
Measured: Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Difficulty Subscale Score
Measured: Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Activity Limitation Subscale Score
Measured: Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Total score
Measured: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Foot Pain Subscale Score
Measured: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Difficulty Subscale Score
Measured: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Activity Limitation Subscale Score
Measured: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS HMT Overall Scale Score
Measured: 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
Measured: Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Difficulty Subscale Score
Measured: Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Activity Limitation Subscale Score
Measured: Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC HMT Overall Scale Score
Measured: Up to Day 57
Change from Baseline in the Pain Intensity Numeric Rating Scale (NRS) Score
Measured: Up to Day 57
Number of Participants With >=1 Point Improvement in the Clinician Global Impression of Change (CGIC) Scale Score
Measured: Up to Day 57
Number of Participants With >=1 Point Improvement in the Subject Satisfaction with Treatment Scale
Measured: Up to Day 57
Number of Participants With a ≥ 30% reduction in Flexion Contracture as measured by Goniometry
Measured: Baseline to Day 57
Number of Participants With a ≥ 50% reduction in Flexion Contracture as measured by Goniometry
Measured: Baseline to Day 57
Number of Participants With TEAEs
Measured: Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start11 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible HammertoeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759362
- Sponsor's protocol ID
- KN3835-313 HMT
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07759362
- Acronym / sponsor ID
- KN3835-313 HMT
- Conditions
- Flexible Hammertoe, Semi-flexible Hammertoe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KN3835 | Experimental | Biological: KN3835 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KN3835Also: EN3835Participants will receive KN3835. | Biological | KN3835 |
| PlaceboParticipants will receive placebo matching to KN3835. | Other | Placebo |
Primary outcome
Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer
Time frame: Baseline, Day 57
23 secondary outcomes
Change From Baseline to Day 57 in the Foot Function Index (FFI) Difficulty Subscale Score
Time frame: Baseline, Day 57
Change From Baseline to Day 57 in the FFI Activity Limitation Subscale Score
Time frame: Baseline, Day 57
Change From Baseline to Day 57 in the Patient Global Impression of Severity (PGIS) HMT Overall Scale Score
Time frame: Baseline, Day 57
Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer
Time frame: Baseline, up to Day 57
Percent Change From Baseline up to Day 57 in Flexion Contracture as Measured by Goniometer
Time frame: Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Pain Subscale Score
Time frame: Baseline, up to Day 57
Change From Baseline up to Day 57 in the FFI Difficulty Subscale Score
Time frame: Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Activity Limitation Subscale Score
Time frame: Baseline, up to Day 57
Change from Baseline up to Day 57 in the FFI Total score
Time frame: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Foot Pain Subscale Score
Time frame: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Difficulty Subscale Score
Time frame: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS Activity Limitation Subscale Score
Time frame: Baseline, up to Day 57
Change from Baseline up to Day 57 in the PGIS HMT Overall Scale Score
Time frame: 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
Time frame: Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Difficulty Subscale Score
Time frame: Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC Activity Limitation Subscale Score
Time frame: Up to Day 57
Number of Participants With >=1 Point Improvement in the PGIC HMT Overall Scale Score
Time frame: Up to Day 57
Change from Baseline in the Pain Intensity Numeric Rating Scale (NRS) Score
Time frame: Up to Day 57
Number of Participants With >=1 Point Improvement in the Clinician Global Impression of Change (CGIC) Scale Score
Time frame: Up to Day 57
Number of Participants With >=1 Point Improvement in the Subject Satisfaction with Treatment Scale
Time frame: Up to Day 57
Number of Participants With a ≥ 30% reduction in Flexion Contracture as measured by Goniometry
Time frame: Baseline to Day 57
Number of Participants With a ≥ 50% reduction in Flexion Contracture as measured by Goniometry
Time frame: Baseline to Day 57
Number of Participants With TEAEs
Time frame: Baseline to Day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Flexible Hammertoe
Not yet recruitingPhase 3
Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
Flexible Hammertoe, Semi-flexible Hammertoe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director, MD study director
Endo USA Inc., a Keenova Therapeutics Company
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KN3835 in people with Flexible Hammertoe and Semi-flexible Hammertoe, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (800-462-3636, clinicaltrials@endo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer (time frame: Baseline, Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.