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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02838628
Recruitment Status : Completed
First Posted : July 20, 2016
Results First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Athenex, Inc.
Information provided by (Responsible Party):
Almirall, S.A.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Actinic Keratosis
Intervention Drug: 50 mg of KX2-391 Ointment 1%
Enrollment 168
Recruitment Details This study was conducted at 16 sites in United States from 11 April 2016 to 22 December 2017.
Pre-assignment Details A total of 168 participants (84 each cohort) were enrolled and treated in this study. This study consisted of 2 periods, first was Treatment and Follow-up period (up to Day 57) and second was Recurrence follow-up period (12 months post-Day 57).
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description 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.
Period Title: Treatment and Follow-up Period
Started 84 84
Completed 84 84
Not Completed 0 0
Period Title: Recurrence Follow-up Period
Started [1] 36 27
Completed 16 10
Not Completed 20 17
Reason Not Completed
AK Recurrence             18             13
Adverse Event             1             0
Non-compliance             0             1
Withdrawal by Subject             0             2
Other un-specified             1             1
[1]
Participants who achieved 100% AK clearance at Day 57 visit entered the recurrence follow-up period.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3) Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 84 84 168
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least one dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 84 participants 168 participants
69.0  (8.93) 67.7  (8.32) 68.3  (8.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 84 participants 168 participants
Female
8
   9.5%
12
  14.3%
20
  11.9%
Male
76
  90.5%
72
  85.7%
148
  88.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 84 participants 168 participants
Hispanic or Latino
3
   3.6%
9
  10.7%
12
   7.1%
Not Hispanic or Latino
81
  96.4%
75
  89.3%
156
  92.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 84 participants 168 participants
American Indian or Alaska Native
0
   0.0%
1
   1.2%
1
   0.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
84
 100.0%
83
  98.8%
167
  99.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Number of AK Lesions  
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 84 participants 84 participants 168 participants
5.8  (1.41) 5.4  (1.19) 5.6  (1.32)
1.Primary Outcome
Title Percentage of Participants With Complete Response of Actinic Keratosis
Hide Description 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.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43
(32 to 54)
32
(22 to 43)
2.Secondary Outcome
Title Percentage of Participants With Partial Response of Actinic Keratosis
Hide Description 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.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(45 to 67)
52
(41 to 63)
3.Secondary Outcome
Title Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57
Hide Description Overall changes from baseline in actinic keratosis lesion counts has been reported.
Time Frame Baseline, Days 8, 15, 29 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Median (Full Range)
Unit of Measure: lesion count
Day 8
0.0
(-7 to 4)
-1.0
(-8 to 3)
Day 15
-2.5
(-8 to 5)
-2.0
(-8 to 2)
Day 29
-3.0
(-8 to 1)
-4.0
(-8 to 2)
Day 57
-4.0
(-8 to 1)
-4.0
(-8 to 0)
4.Secondary Outcome
Title Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame Baseline up to Day 57 (Treatment and follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included group of participants who received at least one dose of study treatment.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Count of Participants
Unit of Measure: Participants
34
  40.5%
18
  21.4%
5.Secondary Outcome
Title Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period
Hide Description 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.
Time Frame From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Recurrence follow-up set included the group of participants who achieved complete clearance at Day 57.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 36 27
Measure Type: Count of Participants
Unit of Measure: Participants
5
  13.9%
3
  11.1%
6.Secondary Outcome
Title Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)
Hide Description 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).
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included group of participants who received at least one dose of study treatment.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema: LSR Grade 0
9
  10.7%
15
  17.9%
Erythema: LSR Grade 1
22
  26.2%
34
  40.5%
Erythema: LSR Grade 2
35
  41.7%
29
  34.5%
Erythema: LSR Grade 3
17
  20.2%
6
   7.1%
Erythema: LSR Grade 4
1
   1.2%
0
   0.0%
Flaking/Scaling: LSR Grade 0
23
  27.4%
20
  23.8%
Flaking/Scaling: LSR Grade 1
20
  23.8%
33
  39.3%
Flaking/Scaling: LSR Grade 2
24
  28.6%
23
  27.4%
Flaking/Scaling: LSR Grade 3
16
  19.0%
8
   9.5%
Flaking/Scaling: LSR Grade 4
1
   1.2%
0
   0.0%
Crusting: LSR Grade 0
49
  58.3%
53
  63.1%
Crusting: LSR Grade 1
27
  32.1%
20
  23.8%
Crusting: LSR Grade 2
8
   9.5%
10
  11.9%
Crusting: LSR Grade 3
0
   0.0%
1
   1.2%
Crusting: LSR Grade 4
0
   0.0%
0
   0.0%
Swelling: LSR Grade 0
66
  78.6%
76
  90.5%
Swelling: LSR Grade 1
16
  19.0%
8
   9.5%
Swelling: LSR Grade 2
1
   1.2%
0
   0.0%
Swelling: LSR Grade 3
1
   1.2%
0
   0.0%
Swelling: LSR Grade 4
0
   0.0%
0
   0.0%
Vesiculation/pustulation: LSR Grade 0
80
  95.2%
83
  98.8%
Vesiculation/pustulation: LSR Grade 1
4
   4.8%
0
   0.0%
Vesiculation/pustulation: LSR Grade 2
0
   0.0%
1
   1.2%
Vesiculation/pustulation: LSR Grade 3
0
   0.0%
0
   0.0%
Vesiculation/pustulation: LSR Grade 4
0
   0.0%
0
   0.0%
Erosion/ulceration: LSR Grade 0
71
  84.5%
78
  92.9%
Erosion/ulceration: LSR Grade 1
12
  14.3%
6
   7.1%
Erosion/ulceration: LSR Grade 2
1
   1.2%
0
   0.0%
Erosion/ulceration: LSR Grade 3
0
   0.0%
0
   0.0%
Erosion/ulceration: LSR Grade 4
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Laboratory
Hide Description Laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance was determined by the investigator.
Time Frame Baseline to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included group of participants who received at least one dose of study treatment.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Vital Signs
Hide Description Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time Frame Baseline up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included group of participants who received at least one dose of study treatment.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
Hide Description 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.
Time Frame Baseline up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included group of participants who received at least one dose of study treatment.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Count of Participants
Unit of Measure: Participants
4
   4.8%
1
   1.2%
10.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)
Hide Description A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Time Frame Baseline up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included group of participants who received at least one dose of study treatment.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391
Hide Description Cmax was defined as the maximum observed plasma concentration obtained directly from the concentration versus time curve.
Time Frame Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter (ng/mL)
NA [1]   (NA) NA [1]   (NA)
[1]
Assessments of the PK parameters were planned but were not conducted due to the minimal absorption of KX2-391 in the plasma following 3 or 5 days of consecutive treatment of the 1% ointment. KX2-391 was below the lower limit of quantification (LLOQ) of 0.1 ng/mL for the majority of plasma samples. The maximum individual plasma concentration in both cohorts and all days of PK sampling did not exceed 2 ng/mL.
12.Secondary Outcome
Title Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391
Hide Description 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.
Time Frame Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
NA [1]   (NA) NA [1]   (NA)
[1]
Assessments of the PK parameters were planned but were not conducted due to the minimal absorption of KX2-391 in the plasma following 3 or 5 days of consecutive treatment of the 1% ointment. KX2-391 was below the lower limit of quantification (LLOQ) of 0.1 ng/mL for the majority of plasma samples.
13.Secondary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of KX2-391
Hide Description Cmin was defined as minimum observed plasma concentration obtained directly from the concentration versus time curve.
Time Frame Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Assessments of the PK parameters were planned but were not conducted due to the minimal absorption of KX2-391 in the plasma following 3 or 5 days of consecutive treatment of the 1% ointment. KX2-391 was below the lower limit of quantification (LLOQ) of 0.1 ng/mL for the majority of plasma samples.
14.Secondary Outcome
Title Accumulation Ratio (R)
Hide Description Ratio calculated from AUC and Cmax found on the last day of treatment and Day 1.
Time Frame Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation.
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 84 84
Mean (Standard Deviation)
Unit of Measure: ratio
NA [1]   (NA) NA [1]   (NA)
[1]
Assessments of the PK parameters were planned but were not conducted due to the minimal absorption of KX2-391 in the plasma following 3 or 5 days of consecutive treatment of the 1% ointment. KX2-391 was below the lower limit of quantification (LLOQ) of 0.1 ng/mL for the majority of plasma samples. The maximum individual plasma concentration in both cohorts and all days of PK sampling did not exceed 2 ng/mL.
Time Frame Baseline up to Recurrence Follow-up (12 months post-day 57)
Adverse Event Reporting Description Safety analysis set included group of participants who received at least one dose of study treatment.
 
Arm/Group Title KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)      0/84 (0.00%)    
Hide Serious Adverse Events
KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/84 (4.76%)      3/84 (3.57%)    
Cardiac disorders     
Arteriosclerosis Coronary Artery * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Gastrointestinal disorders     
Small Intestinal Obstruction * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Infections and infestations     
Appendicitis * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Nervous system disorders     
Cerebrovascular Accident * 1  1/84 (1.19%)  1 1/84 (1.19%)  1
VIIth Nerve Paralysis * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  2/84 (2.38%)  2 0/84 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
KX2-391 50 mg (Days 1 to 5) KX2-391 50 mg (Days 1 to 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/84 (44.05%)      19/84 (22.62%)    
Cardiac disorders     
Atrioventricular Block First Degree * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Defect Conduction Intraventricular * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Myocardial Infarction * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Myocardial Ischaemia * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Sinus Bradycardia * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Eye disorders     
Eye Discharge * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Eye Pruritus * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Constipation * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Diarrhoea * 1  2/84 (2.38%)  2 0/84 (0.00%)  0
Diverticulum * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Nausea * 1  1/84 (1.19%)  1 1/84 (1.19%)  1
Vomiting * 1  1/84 (1.19%)  1 1/84 (1.19%)  1
General disorders     
Application Site Pain * 1  3/84 (3.57%)  3 2/84 (2.38%)  2
Application Site Pruritus * 1  6/84 (7.14%)  7 1/84 (1.19%)  1
Feeling Of Body Temperature Change * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Pyrexia * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Hepatobiliary disorders     
Cholelithiasis * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Immune system disorders     
Dermatitis Contact * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Infections and infestations     
Bacteriuria * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Hordeolum * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Influenza * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Nasopharyngitis * 1  1/84 (1.19%)  1 2/84 (2.38%)  2
Oral Herpes * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Tooth Infection * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Upper Respiratory Tract Infection * 1  1/84 (1.19%)  1 2/84 (2.38%)  2
Urinary Tract Infection * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Injury, poisoning and procedural complications     
Clavicle Fracture * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Excoriation * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Laceration * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Ligament Sprain * 1  1/84 (1.19%)  2 0/84 (0.00%)  0
Muscle Strain * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Overdose * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Rib Fracture * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Scratch * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Skin Injury * 1  3/84 (3.57%)  3 1/84 (1.19%)  1
Investigations     
Electrocardiogram QT Prolonged * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Diabetes Mellitus * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/84 (1.19%)  1 3/84 (3.57%)  3
Back Pain * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Joint Swelling * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Meniscus Injury * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Muscle Strain * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Tendonitis * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous Cell Carcinoma * 1  1/84 (1.19%)  1 1/84 (1.19%)  1
Squamous Cell Carcinoma Of Skin * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Nervous system disorders     
Dizziness * 1  3/84 (3.57%)  3 0/84 (0.00%)  0
Headache * 1  2/84 (2.38%)  2 1/84 (1.19%)  1
Hypoaesthesia * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Vertigo * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Renal and urinary disorders     
Chronic Kidney Disease * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Cystitis * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Haematuria * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Urinary Retention * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Urinary Tract Infection * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Nasopharyngitis * 1  2/84 (2.38%)  2 1/84 (1.19%)  1
Skin and subcutaneous tissue disorders     
Actinic Keratosis * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Ecchymosis * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Hair Colour Changes * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Penile Ulceration * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Petechiae * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Scab * 1  0/84 (0.00%)  0 1/84 (1.19%)  1
Skin Injury * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Surgical and medical procedures     
Tooth Extraction * 1  1/84 (1.19%)  1 0/84 (0.00%)  0
Vascular disorders     
Hypertension * 1  3/84 (3.57%)  3 3/84 (3.57%)  3
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Global Clinical Development
Organization: Almirall S.A.
Phone: +34932913000
EMail: rd@almirall.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02838628    
Other Study ID Numbers: KX01-AK-002
U1111-1173-5677 ( Other Identifier: UTN )
First Submitted: July 18, 2016
First Posted: July 20, 2016
Results First Submitted: February 16, 2021
Results First Posted: April 14, 2021
Last Update Posted: April 14, 2021