Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

All Drugs and Chemicals

Tirbanibulin

Enzyme Inhibitors

Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm\^2) treatment area, once daily for 5 consecutive days.

Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm\^2 treatment area, once daily for 3 consecutive days.

Dose: 50 mg; Route of administration: Topical

50 mg of KX2-391 Ointment 1%

Jane Fang, MD

In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.

This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK.

The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.

Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

A Phase 2a, Open-Label, Multicenter, Activity and Safety Study of KX2-391 Ointment 1% in Subjects With Actinic Keratosis on the Face or Scalp

Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57.

Partial response rate was defined as the percentage of participants achieving more than or equal to 75% clearance in the treatment area on the face or scalp at Day 57.

Overall changes from baseline in actinic keratosis lesion counts has been reported.

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational Product (IP). An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an IP. An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.

Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. Local skin reactions assessment included signs of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration on the treatment area. These signs were assessed using a 5-point grading scale ranging from 0 (not present) to 4 (worst), where (grade 0 = absent, grade 1 = slight, grade 2 = moderate, grade 3 = severe, grade 4 = very severe).

Laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance was determined by the investigator.

Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.

ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.

A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.

Cmax was defined as the maximum observed plasma concentration obtained directly from the concentration versus time curve.

Area under the plasma concentration versus time curve from time zero to the last sampling time (t) at which the concentration is at or above the LLOQ. AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.

Cmin was defined as minimum observed plasma concentration obtained directly from the concentration versus time curve.

Ratio calculated from AUC and Cmax found on the last day of treatment and Day 1.

Athenex, Inc.

Almirall, S.A.

Safety analysis set included group of participants who received at least one dose of study treatment.

Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm\^2 treatment area, once daily for 5 consecutive days.

KX2-391 50 mg (Days 1 to 5)

KX2-391 50 mg (Days 1 to 3)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Number of AK Lesions

Safety analysis set included all participants who received at least one dose of study treatment.

Head of Global Clinical Development

Evaluable set included group of protocol-eligible participants who received 5 days (Cohort 1) or 3 days (Cohort 2) of study treatment and completed Day 1 and Day 57 AK lesion evaluations.

Percentage of Participants With Complete Response of Actinic Keratosis

Per-protocol set included the group of protocol-eligible participants who received 5 days (Cohort 1) or 3 days (Cohort 2) of study treatment and completed at least one scheduled post treatment AK lesion evaluation.

Percentage of Participants With Partial Response of Actinic Keratosis

Day 8

Day 15

Day 29

Day 57

Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)

Recurrence follow-up set included the group of participants who achieved complete clearance at Day 57.

Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period

Erythema: LSR Grade 0

Erythema: LSR Grade 1

Erythema: LSR Grade 2

Erythema: LSR Grade 3

Erythema: LSR Grade 4

Flaking/Scaling: LSR Grade 0

Flaking/Scaling: LSR Grade 1

Flaking/Scaling: LSR Grade 2

Flaking/Scaling: LSR Grade 3

Flaking/Scaling: LSR Grade 4

Crusting: LSR Grade 0

Crusting: LSR Grade 1

Crusting: LSR Grade 2

Crusting: LSR Grade 3

Crusting: LSR Grade 4

Swelling: LSR Grade 0

Swelling: LSR Grade 1

Swelling: LSR Grade 2

Swelling: LSR Grade 3

Swelling: LSR Grade 4

Vesiculation/pustulation: LSR Grade 0

Vesiculation/pustulation: LSR Grade 1

Vesiculation/pustulation: LSR Grade 2

Vesiculation/pustulation: LSR Grade 3

Vesiculation/pustulation: LSR Grade 4

Erosion/ulceration: LSR Grade 0

Erosion/ulceration: LSR Grade 1

Erosion/ulceration: LSR Grade 2

Erosion/ulceration: LSR Grade 3

Erosion/ulceration: LSR Grade 4

Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)

Number of Participants With Clinically Significant Abnormalities in Laboratory

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)

Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)

Pharmacokinetic (PK) Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation.

Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391

PK Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation.

Spots Global Cancer Trial Database for Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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