Trial Outcomes & Findings for Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis (NCT NCT03392168)
NCT ID: NCT03392168
Last Updated: 2022-08-04
Results Overview
Difference in least squares mean percent change from baseline at Week 4 in the product of target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.
COMPLETED
PHASE1/PHASE2
91 participants
Baseline and Week 4
2022-08-04
Participant Flow
The study was conducted in 7 centers in Canada and 1 center in the United States (US). There was a total of 91 unique participants; 6 participants who completed Cohort 1 also participated in Cohort 2, with 2 per treatment group.
Participant milestones
| Measure |
Cohort 1 - ARQ-151 Cream 0.5%
Single-dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s)
|
Cohort 2 - ARQ-151 Cream 0.5%
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
|---|---|---|---|---|
|
Period 1: Cohort 1
STARTED
|
8
|
0
|
0
|
0
|
|
Period 1: Cohort 1
COMPLETED
|
8
|
0
|
0
|
0
|
|
Period 1: Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2: Cohort 2
STARTED
|
0
|
30
|
28
|
31
|
|
Period 2: Cohort 2
COMPLETED
|
0
|
28
|
27
|
30
|
|
Period 2: Cohort 2
NOT COMPLETED
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1 - ARQ-151 Cream 0.5%
Single-dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s)
|
Cohort 2 - ARQ-151 Cream 0.5%
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
|---|---|---|---|---|
|
Period 2: Cohort 2
Lost to Follow-up
|
0
|
1
|
1
|
1
|
|
Period 2: Cohort 2
Other
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Cohort 1 - ARQ-151 Cream 0.5%
n=8 Participants
Single-dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s)
|
Cohort 2 - ARQ-151 Cream 0.5%
n=28 Participants
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
n=26 Participants
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
n=29 Participants
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.6 Years
STANDARD_DEVIATION 16.92 • n=5 Participants
|
50.8 Years
STANDARD_DEVIATION 15.76 • n=7 Participants
|
54.8 Years
STANDARD_DEVIATION 13.50 • n=5 Participants
|
47.0 Years
STANDARD_DEVIATION 13.97 • n=4 Participants
|
50.80 Years
STANDARD_DEVIATION 14.75 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: The modified intent-to-treat (mITT) population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation.
Difference in least squares mean percent change from baseline at Week 4 in the product of target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.
Outcome measures
| Measure |
Cohort 2 - ARQ-151 Cream 0.5%
n=28 Participants
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
n=27 Participants
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
n=30 Participants
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
|---|---|---|---|
|
Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
|
-66.6 Percent change
Standard Error 7.27
|
-66.0 Percent change
Standard Error 7.61
|
-38.1 Percent change
Standard Error 7.34
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2 and 3Population: The mITT population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation.
Difference in least squares mean percent change from baseline at Weeks 1, 2 and 3 in target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.
Outcome measures
| Measure |
Cohort 2 - ARQ-151 Cream 0.5%
n=30 Participants
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
n=27 Participants
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
n=31 Participants
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
|---|---|---|---|
|
Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
Week 1
|
-34.7 Percent change
Standard Error 5.79
|
-36.4 Percent change
Standard Error 6.16
|
-31.5 Percent change
Standard Error 5.99
|
|
Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
Week 2
|
-48.7 Percent change
Standard Error 6.40
|
-50.1 Percent change
Standard Error 6.75
|
-30.4 Percent change
Standard Error 6.55
|
|
Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
Week 3
|
-61.5 Percent change
Standard Error 6.69
|
-55.6 Percent change
Standard Error 7.03
|
-32.6 Percent change
Standard Error 6.81
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, and 4Population: The mITT population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation.
Difference in least squares mean percent change from baseline at Weeks 1, 2, 3 and 4 in total plaque severity score (TPSS) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. A negative percent change indicates improvement.
Outcome measures
| Measure |
Cohort 2 - ARQ-151 Cream 0.5%
n=30 Participants
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
n=27 Participants
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
n=31 Participants
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
|---|---|---|---|
|
Percent Change From Baseline in Total Plaque Severity Score in Cohort 2
Week 1
|
-30.5 Percent change
Standard Error 4.96
|
-34.3 Percent change
Standard Error 5.20
|
-26.2 Percent change
Standard Error 5.16
|
|
Percent Change From Baseline in Total Plaque Severity Score in Cohort 2
Week 2
|
-41.9 Percent change
Standard Error 5.01
|
-45.6 Percent change
Standard Error 5.22
|
-26.4 Percent change
Standard Error 5.19
|
|
Percent Change From Baseline in Total Plaque Severity Score in Cohort 2
Week 3
|
-51.5 Percent change
Standard Error 5.46
|
-52.0 Percent change
Standard Error 5.63
|
-30.1 Percent change
Standard Error 5.56
|
|
Percent Change From Baseline in Total Plaque Severity Score in Cohort 2
Week 4
|
-55.1 Percent change
Standard Error 5.41
|
-58.2 Percent change
Standard Error 5.56
|
-36.5 Percent change
Standard Error 5.50
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, and 4Population: The mITT population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation.
Difference in least squares mean percent change from baseline at Weeks 1, 2, 3, and 4 in target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPA score as a covariate. Target plaque area (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.
Outcome measures
| Measure |
Cohort 2 - ARQ-151 Cream 0.5%
n=30 Participants
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
n=27 Participants
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
n=31 Participants
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
|---|---|---|---|
|
Percent Change From Baseline in Target Plaque Area in Cohort 2
Week 1
|
-9.15 Percent change
Standard Error 2.981
|
-8.22 Percent change
Standard Error 3.198
|
-11.82 Percent change
Standard Error 3.089
|
|
Percent Change From Baseline in Target Plaque Area in Cohort 2
Week 2
|
-14.95 Percent change
Standard Error 4.211
|
-16.19 Percent change
Standard Error 4.407
|
-10.37 Percent change
Standard Error 4.225
|
|
Percent Change From Baseline in Target Plaque Area in Cohort 2
Week 3
|
-22.63 Percent change
Standard Error 4.666
|
-17.00 Percent change
Standard Error 4.844
|
-9.95 Percent change
Standard Error 4.636
|
|
Percent Change From Baseline in Target Plaque Area in Cohort 2
Week 4
|
-31.87 Percent change
Standard Error 6.014
|
-28.28 Percent change
Standard Error 6.228
|
-11.61 Percent change
Standard Error 5.938
|
Adverse Events
Cohort 1 - ARQ-151 Cream 0.5%
Cohort 2 - ARQ-151 Cream 0.5%
Cohort 2 - ARQ-151 Cream 0.15%
Cohort 2 - ARQ-151 Vehicle Cream
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 - ARQ-151 Cream 0.5%
n=8 participants at risk
Single-dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s)
|
Cohort 2 - ARQ-151 Cream 0.5%
n=30 participants at risk
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Cream 0.15%
n=28 participants at risk
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
Cohort 2 - ARQ-151 Vehicle Cream
n=31 participants at risk
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
0.00%
0/30 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
0.00%
0/28 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
6.5%
2/31 • Number of events 2 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
|
Infections and infestations
Candiduria
|
12.5%
1/8 • Number of events 1 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
0.00%
0/30 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
0.00%
0/28 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
0.00%
0/31 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
|
General disorders
Application site erythema
|
0.00%
0/8 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
13.3%
4/30 • Number of events 4 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
3.6%
1/28 • Number of events 1 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
12.9%
4/31 • Number of events 4 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
|
General disorders
Application site pain
|
0.00%
0/8 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
6.7%
2/30 • Number of events 2 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
3.6%
1/28 • Number of events 1 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
16.1%
5/31 • Number of events 5 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
6.7%
2/30 • Number of events 2 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
7.1%
2/28 • Number of events 2 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
0.00%
0/31 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/8 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
3.3%
1/30 • Number of events 1 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
3.6%
1/28 • Number of events 1 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
6.5%
2/31 • Number of events 2 • Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place