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KN3835

Phase 3

Flexible Hammertoe | Monoclonal antibody | Other |BrainsWay Ltd.|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment554

FDA Designations

No designations recorded

Clinical trial landscape

KN3835 · 1 trial · 2 indications

Phase 3 1
NCT07759362Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)Flexible Hammertoe
NOT YET_RECRUITING554 Analytics
PHASE3NOT YET_RECRUITING
Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
Flexible Hammertoe
NCT07759362554
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Study Endpoints

Primary Endpoints

Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer
Baseline, Day 57

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KN3835EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
KN3835BIOLOGICALParticipants will receive KN3835.
PlaceboOTHERParticipants will receive placebo matching to KN3835.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

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...

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Frequently asked questions about KN3835

What is KN3835 used for?

KN3835 is an investigational monoclonal antibody being studied for the treatment of flexible and semi-flexible hammertoe, a condition where the toe joint bends abnormally. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

What does KN3835 target?

KN3835 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being evaluated in a Phase 3 trial for flexible and semi-flexible hammertoe, with the study designed to assess its efficacy and safety compared to placebo.

Who makes KN3835?

KN3835 is being developed by BrainsWay Ltd., a company publicly traded under the ticker BWAY. The company is conducting a Phase 3 clinical trial to evaluate the drug for the treatment of flexible and semi-flexible hammertoe.

What phase is KN3835 in?

KN3835 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is designed to assess its safety and efficacy in patients with flexible or semi-flexible hammertoe.

What clinical trials is KN3835 in?

KN3835 is being studied in a Phase 3 clinical trial with the identifier NCT07759362. This randomized, double-blind, placebo-controlled study is not yet recruiting and aims to enroll 554 participants aged 18 years and older with flexible or semi-flexible hammertoe.