Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 20

List	Outcome	Time frame	Description
Primary	To assess the safety of repeated doses of oral KM-023 in individuals with PC.	Day 112	The incidence, seriousness, relationship, and outcome of TEAEs.
Primary	To assess the safety of repeated doses of oral KM-023 in individuals with PC.	Day 112	Change from baseline in clinical laboratory parameters.
Primary	To assess the safety of repeated doses of oral KM-023 in individuals with PC.	Day 112	Change from baseline in vital signs.
Primary	To assess the safety of repeated doses of oral KM-023 in individuals with PC.	Day 112	Change from baseline in 12-lead ECG
Primary	To assess the safety of repeated doses of oral KM-023 in individuals with PC.	Day 112	Change from baseline in physical examination.
Primary	To assess the tolerability of repeated doses of oral KM-023 in individuals with PC.	Day 112	Proportions of participants who completed 112 days of treatment and who discontinued treatment due to a TEAE (tolerability).
Secondary	Change from baseline to Day 112 in duration of the Timed up and Go (TUG) test completion.	Day 112
Secondary	Change from baseline to Day 112 in post-TUG test pain NRS score.	Day 112
Secondary	Change from baseline to Day 112 in pre-TUG test pain numeric rating scale (NRS) score.	Day 112
Secondary	Change from baseline to Day 112 in the weekly average of three times a week plantar pain NRS assessment.	Day 112
Secondary	Plasma and skin (when feasible) concentration of KM-023 and potentially M10 at every in-clinic visit.	Day 112
Secondary	Change from baseline to Day 112 in patient reported outcomes measurement information system (PROMIS) physical function (PF) custom questionnaire score.	Day 112
Secondary	Assessment of the disease characteristics of PC based on patient-reported responses to a questionnaire evaluating key disease manifestations, symptom progression, and impact on daily life.	Day 112
Secondary	Change from Baseline to Day 112 in total Patient-Reported Impact of Dermatological Diseases (PRIDD) score.	Day 112
Secondary	Change from Baseline to Day 112 in Clinical Global Impression Severity (CGI-S) score.	Day 112
Secondary	Change from Baseline to Day 112 in Clinical Global Impression Change (CGI-C) score.	Day 112
Other	Change from Baseline to D112, in the plantar calluses area . (Area will be measured using photography)	Day 112
Other	To explore the effect of KM-023 on TRPV3 expression and biomarkers.	Day 112
Other	Relationship between KM-023 exposure parameters (KM-023 plasma and/or biopsy concentrations) and duration of TUG completion and/or related pain.	Day 112
Other	Relationship between KM-023 exposure parameters (KM-023 plasma and/or biopsy concentrations) and reduction in lesion area as measured by photography.	Day 112

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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