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NCT07846280
Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
Conditions: Flexible Hammertoe, Semi-flexible Hammertoe
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 470
Sponsor: Endo USA Inc., a Keenova Therapeutics Company
Summary
The primary purpose of this study is to assess the long-term safety of treatment and retreatment with KN3835 for flexible/semi-flexible HMT.
Eligibility Criteria
Inclusion Criteria:
* Were enrolled in and completed Study KN3835-313 (participants who completed the study are those that completed the Day 57/End of Study Visit, were assessed for safety, and received at least 1 dose of study intervention).
* 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 significant medical condition, or a serious or severe event in the parent study or any ongoing event from the parent study, which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
* Has received or plans to receive surgical or nonsurgical treatments on the foot or toe that was treated for the duration of study participation.
Note: Other inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07846280). StuddyBuddy aggregates publicly available trial information.