Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
Part of paid clinical trials in Corona, California.
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Study ID
- NCT07759362
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Flexible Hammertoe
- Semi-flexible Hammertoe
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- KN3835 — BIOLOGICALParticipants will receive KN3835.
- Placebo — OTHERParticipants will receive placebo matching to KN3835.
Study Details
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.
Key Dates
- First listed
- Aug 12, 2026
- Start date
- Aug 11, 2026
- Status verified
- Sep 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 554 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: KN3835
- Placebo Comparator: Placebo
Primary Outcome Measure
Change From Baseline to Day 57 in Flexion Contracture as Measured by Goniometer [ Time Frame: Baseline, Day 57 ]
Central Contacts
- Clinical Operations800-462-3636
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Keenova Site-009 | Corona | California | 92882 | Babak Alavynejad (PRINCIPAL_INVESTIGATOR) |
| Keenova Site-008 | Tarzana | California | 91356 | Fardin Hakakian (PRINCIPAL_INVESTIGATOR) |
| Keenova Site-004 | Pinellas Park | Florida | 33782 | Jason Levy (PRINCIPAL_INVESTIGATOR) |
| Keenova Site-007 | Sweetwater | Florida | 33172 | Edward Gonzalez (PRINCIPAL_INVESTIGATOR) |
| Keenova Site-003 | Bedford | Texas | 76021 | Howard Harris (PRINCIPAL_INVESTIGATOR) |
| Keenova Site-002 | McAllen | Texas | 78501 | Joseph Caporusso (PRINCIPAL_INVESTIGATOR) |
| Keenova Site-006 | Salt Lake City | Utah | 84107 | Clark Larsen (PRINCIPAL_INVESTIGATOR) |