Trial Outcomes & Findings for The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis (NCT NCT03638258)
NCT ID: NCT03638258
Last Updated: 2022-09-02
Results Overview
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
COMPLETED
PHASE2
331 participants
Week 6
2022-09-02
Participant Flow
Adult (≥18 years of age) male or female participants with chronic plaque psoriasis were recruited at 30 study sites in the US and Canada.
Participant milestones
| Measure |
Rolumilast Cream 0.3%
Roflumilast (ARQ-151) cream 0.3% was topically applied once daily (QD) for 12 weeks.
|
Roflumilast Cream 0.15%
Roflumilast (ARQ-151) cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
113
|
109
|
|
Overall Study
COMPLETED
|
102
|
104
|
86
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
23
|
Reasons for withdrawal
| Measure |
Rolumilast Cream 0.3%
Roflumilast (ARQ-151) cream 0.3% was topically applied once daily (QD) for 12 weeks.
|
Roflumilast Cream 0.15%
Roflumilast (ARQ-151) cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
5
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
12
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
Baseline Characteristics
All randomized participants with intertriginous area involvement are included.
Baseline characteristics by cohort
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 14.11 • n=109 Participants
|
54.4 years
STANDARD_DEVIATION 14.20 • n=113 Participants
|
55.5 years
STANDARD_DEVIATION 13.49 • n=109 Participants
|
53.9 years
STANDARD_DEVIATION 13.99 • n=331 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=109 Participants
|
51 Participants
n=113 Participants
|
42 Participants
n=109 Participants
|
146 Participants
n=331 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=109 Participants
|
62 Participants
n=113 Participants
|
67 Participants
n=109 Participants
|
185 Participants
n=331 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=109 Participants
|
26 Participants
n=113 Participants
|
25 Participants
n=109 Participants
|
76 Participants
n=331 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=109 Participants
|
87 Participants
n=113 Participants
|
84 Participants
n=109 Participants
|
255 Participants
n=331 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=109 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=331 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=109 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=109 Participants
|
7 Participants
n=113 Participants
|
5 Participants
n=109 Participants
|
20 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
12 Participants
n=109 Participants
|
10 Participants
n=113 Participants
|
7 Participants
n=109 Participants
|
29 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=109 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=331 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=109 Participants
|
95 Participants
n=113 Participants
|
92 Participants
n=109 Participants
|
269 Participants
n=331 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=109 Participants
|
1 Participants
n=113 Participants
|
4 Participants
n=109 Participants
|
12 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=109 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=331 Participants
|
|
Whole Body Investigator Global Assessment (IGA) Score
0 - Clear
|
0 Participants
n=109 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=331 Participants
|
|
Whole Body Investigator Global Assessment (IGA) Score
1 - Almost Clear
|
0 Participants
n=109 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=331 Participants
|
|
Whole Body Investigator Global Assessment (IGA) Score
2 - Mild
|
17 Participants
n=109 Participants
|
18 Participants
n=113 Participants
|
11 Participants
n=109 Participants
|
46 Participants
n=331 Participants
|
|
Whole Body Investigator Global Assessment (IGA) Score
3 - Moderate
|
84 Participants
n=109 Participants
|
83 Participants
n=113 Participants
|
89 Participants
n=109 Participants
|
256 Participants
n=331 Participants
|
|
Whole Body Investigator Global Assessment (IGA) Score
4 - Severe
|
8 Participants
n=109 Participants
|
12 Participants
n=113 Participants
|
9 Participants
n=109 Participants
|
29 Participants
n=331 Participants
|
|
Intertriginous Area Investigator Global Assessment (I-IGA) Score
1 - Almost Clear
|
1 Participants
n=16 Participants • All randomized participants with intertriginous area involvement are included.
|
2 Participants
n=18 Participants • All randomized participants with intertriginous area involvement are included.
|
0 Participants
n=17 Participants • All randomized participants with intertriginous area involvement are included.
|
3 Participants
n=51 Participants • All randomized participants with intertriginous area involvement are included.
|
|
Intertriginous Area Investigator Global Assessment (I-IGA) Score
2 - Mild
|
6 Participants
n=16 Participants • All randomized participants with intertriginous area involvement are included.
|
12 Participants
n=18 Participants • All randomized participants with intertriginous area involvement are included.
|
7 Participants
n=17 Participants • All randomized participants with intertriginous area involvement are included.
|
25 Participants
n=51 Participants • All randomized participants with intertriginous area involvement are included.
|
|
Intertriginous Area Investigator Global Assessment (I-IGA) Score
3 - Moderate
|
8 Participants
n=16 Participants • All randomized participants with intertriginous area involvement are included.
|
3 Participants
n=18 Participants • All randomized participants with intertriginous area involvement are included.
|
8 Participants
n=17 Participants • All randomized participants with intertriginous area involvement are included.
|
19 Participants
n=51 Participants • All randomized participants with intertriginous area involvement are included.
|
|
Intertriginous Area Investigator Global Assessment (I-IGA) Score
4 - Severe
|
1 Participants
n=16 Participants • All randomized participants with intertriginous area involvement are included.
|
1 Participants
n=18 Participants • All randomized participants with intertriginous area involvement are included.
|
2 Participants
n=17 Participants • All randomized participants with intertriginous area involvement are included.
|
4 Participants
n=51 Participants • All randomized participants with intertriginous area involvement are included.
|
|
Itch-Related Sleep Loss Score
|
2.9 score on a scale
STANDARD_DEVIATION 3.24 • n=109 Participants
|
3.0 score on a scale
STANDARD_DEVIATION 3.19 • n=113 Participants
|
3.4 score on a scale
STANDARD_DEVIATION 3.18 • n=109 Participants
|
3.1 score on a scale
STANDARD_DEVIATION 3.20 • n=331 Participants
|
|
Percentage of Body Surface Area (BSA) Affected
|
6.33 percentage of body surface area
STANDARD_DEVIATION 4.005 • n=109 Participants
|
6.44 percentage of body surface area
STANDARD_DEVIATION 3.915 • n=113 Participants
|
6.43 percentage of body surface area
STANDARD_DEVIATION 3.597 • n=109 Participants
|
6.40 percentage of body surface area
STANDARD_DEVIATION 3.833 • n=331 Participants
|
|
Modified Psoriasis Area Severity Index (mPASI) Score
|
5.94 score on a scale
STANDARD_DEVIATION 3.959 • n=109 Participants
|
6.33 score on a scale
STANDARD_DEVIATION 4.363 • n=113 Participants
|
5.77 score on a scale
STANDARD_DEVIATION 3.498 • n=109 Participants
|
6.02 score on a scale
STANDARD_DEVIATION 3.956 • n=331 Participants
|
|
Worst Itch - Numerical Rating Scale (WI-NRS) Score
|
6.1 score on a scale
STANDARD_DEVIATION 2.67 • n=109 Participants
|
5.6 score on a scale
STANDARD_DEVIATION 3.05 • n=113 Participants
|
5.9 score on a scale
STANDARD_DEVIATION 2.87 • n=109 Participants
|
5.9 score on a scale
STANDARD_DEVIATION 2.87 • n=331 Participants
|
|
Total Psoriasis Symptom Diary (PSD) Score
|
68.9 score on a scale
STANDARD_DEVIATION 41.18 • n=109 Participants
|
69.6 score on a scale
STANDARD_DEVIATION 46.20 • n=113 Participants
|
75.1 score on a scale
STANDARD_DEVIATION 42.55 • n=109 Participants
|
71.2 score on a scale
STANDARD_DEVIATION 43.35 • n=331 Participants
|
|
Dermatology Life Quality Index (DLQI) Score
|
6.7 score on a scale
STANDARD_DEVIATION 5.50 • n=109 Participants
|
8.8 score on a scale
STANDARD_DEVIATION 7.15 • n=113 Participants
|
8.5 score on a scale
STANDARD_DEVIATION 5.62 • n=109 Participants
|
8.0 score on a scale
STANDARD_DEVIATION 6.17 • n=331 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: All randomized participants are included.
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6
|
28.0 percentage of participants
|
22.8 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or last observation carried forward (LOCF) \[subjects with assessments only before the missing assessment\].
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
Week 4
|
14.5 percentage of participants
|
9.0 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
Week 8
|
37.9 percentage of participants
|
30.6 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
Week 12
|
37.5 percentage of participants
|
32.1 percentage of participants
|
16.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The percent change from baseline in mPASI score is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. For scoring, the body is divided into four sections (head \[h\]: 10% of a person's skin; arms \[a\] 20%; trunk \[t\] 30%; legs (l\] 40%); for each section, the percent of area involved is estimated from 0 (0% involved) to 6 (90 to 100% involved). Then, within each area, the severity is estimated by three clinical signs: erythema ('E'; redness), induration ('T'; thickness), and desquamation ('S'; scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum severity possible. Each of these areas is scored by itself, and then the four scores are combined into the final mPASI, using the formula mPASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 0.4 (El + Tl + Sl) Al.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
Week 4
|
-40.08 score on a scale
Standard Deviation 46.811
|
-47.32 score on a scale
Standard Deviation 29.717
|
-18.01 score on a scale
Standard Deviation 46.622
|
|
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
Week 6
|
-53.15 score on a scale
Standard Deviation 46.470
|
-59.73 score on a scale
Standard Deviation 32.409
|
-16.42 score on a scale
Standard Deviation 58.385
|
|
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
Week 8
|
-59.09 score on a scale
Standard Deviation 49.290
|
-65.12 score on a scale
Standard Deviation 31.97
|
-18.47 score on a scale
Standard Deviation 63.777
|
|
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
Week 12
|
-59.48 score on a scale
Standard Deviation 54.881
|
-68.03 score on a scale
Standard Deviation 33.021
|
-13.65 score on a scale
Standard Deviation 70.731
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The BSA affected by psoriasis was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. The mean percent change from baseline in BSA is presented.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Body Surface Area (BSA) Affected
Week 4
|
-21.74 percentage of change
Standard Deviation 34.381
|
-23.25 percentage of change
Standard Deviation 27.084
|
-5.33 percentage of change
Standard Deviation 31.834
|
|
Percent Change From Baseline in Body Surface Area (BSA) Affected
Week 6
|
-34.88 percentage of change
Standard Deviation 39.530
|
-33.41 percentage of change
Standard Deviation 32.136
|
-8.19 percentage of change
Standard Deviation 40.989
|
|
Percent Change From Baseline in Body Surface Area (BSA) Affected
Week 8
|
-41.58 percentage of change
Standard Deviation 42.816
|
-40.49 percentage of change
Standard Deviation 34.379
|
-7.40 percentage of change
Standard Deviation 52.859
|
|
Percent Change From Baseline in Body Surface Area (BSA) Affected
Week 12
|
-48.56 percentage of change
Standard Deviation 46.077
|
-47.50 percentage of change
Standard Deviation 36.304
|
-6.74 percentage of change
Standard Deviation 51.469
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') plus a 2-grade improvement from baseline is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
Week 4
|
10.0 percentage of participants
|
6.9 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
Week 6
|
23.9 percentage of participants
|
17.4 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
Week 8
|
32.2 percentage of participants
|
24.5 percentage of participants
|
9.8 percentage of participants
|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
Week 12
|
31.3 percentage of participants
|
27.4 percentage of participants
|
13.6 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The percentage of participants (who had intertriginous area involvement with an I-IGA score of at least mild at baseline) with at least a 2-grade improvement in I-IGA score at Weeks 4, 6, 8, and 12 is presented.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline
Week 4
|
46.6 percentage of participants
|
43.8 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline
Week 6
|
73.4 percentage of participants
|
43.7 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline
Week 8
|
87.1 percentage of participants
|
60.9 percentage of participants
|
36.1 percentage of participants
|
|
Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline
Week 12
|
94.3 percentage of participants
|
32.4 percentage of participants
|
24.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean (SD) change in WI-NRS score from baseline is presented.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
Week 4
|
-2.8 score on a scale
Standard Deviation 2.53
|
-1.9 score on a scale
Standard Deviation 2.45
|
-1.1 score on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
Week 6
|
-3.3 score on a scale
Standard Deviation 2.56
|
-2.6 score on a scale
Standard Deviation 2.73
|
-1.3 score on a scale
Standard Deviation 2.67
|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
Week 8
|
-3.5 score on a scale
Standard Deviation 2.59
|
-2.9 score on a scale
Standard Deviation 2.73
|
-1.5 score on a scale
Standard Deviation 3.00
|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
Week 12
|
-3.4 score on a scale
Standard Deviation 2.76
|
-3.2 score on a scale
Standard Deviation 2.84
|
-1.3 score on a scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants with a WI-NRS score ≥6 at baseline are included. All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The percentage of participants who had baseline WI-NRS scores ≥6 who achieved a 4-point reduction in WI-NRS score at Weeks 4, 6, 8, and 12 is reported. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=71 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=62 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=64 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
Week 4
|
50.9 percentage of participants
|
35.4 percentage of participants
|
24.9 percentage of participants
|
|
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
Week 6
|
52.8 percentage of participants
|
57.0 percentage of participants
|
34.5 percentage of participants
|
|
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
Week 8
|
64.6 percentage of participants
|
58.2 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
Week 12
|
62.8 percentage of participants
|
70.1 percentage of participants
|
32.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The percentage of subjects achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
Week 4
|
13.3 percentage of participants
|
7.6 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
Week 6
|
24.1 percentage of participants
|
22.2 percentage of participants
|
9.6 percentage of participants
|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
Week 8
|
31.3 percentage of participants
|
23.0 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
Week 12
|
34.1 percentage of participants
|
31.1 percentage of participants
|
16.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. The percentage of subjects achieving a 90% reduction in mPASI (eg, mPASI-90) score relative to baseline is presented.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
Week 4
|
6.0 percentage of participants
|
1.3 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
Week 6
|
14.3 percentage of participants
|
2.3 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
Week 8
|
16.9 percentage of participants
|
7.4 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
Week 12
|
20.6 percentage of participants
|
13.7 percentage of participants
|
7.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 11 ("worst imaginable symptoms"). Scores range from 0 to 176, with higher scores indicating greater symptom severity. The mean (SD) change in PSD total score relative to baseline is presented for each treatment arm.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
Week 4
|
-32.7 percentage of participants
Standard Deviation 34.61
|
-32.7 percentage of participants
Standard Deviation 35.08
|
-22.9 percentage of participants
Standard Deviation 31.85
|
|
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
Week 6
|
-37.8 percentage of participants
Standard Deviation 35.71
|
-38.0 percentage of participants
Standard Deviation 37.88
|
-24.6 percentage of participants
Standard Deviation 38.15
|
|
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
Week 8
|
-40.5 percentage of participants
Standard Deviation 36.62
|
-40.1 percentage of participants
Standard Deviation 39.04
|
-26.9 percentage of participants
Standard Deviation 41.78
|
|
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
Week 12
|
-40.8 percentage of participants
Standard Deviation 41.12
|
-43.4 percentage of participants
Standard Deviation 40.44
|
-23.0 percentage of participants
Standard Deviation 41.38
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. The mean (SD) change from the baseline NRS score is presented for each treatment arm.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
Week 4
|
-1.1 score on a scale
Standard Deviation 2.95
|
-1.2 score on a scale
Standard Deviation 2.54
|
-1.0 score on a scale
Standard Deviation 2.74
|
|
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
Week 6
|
-1.5 score on a scale
Standard Deviation 2.94
|
-1.3 score on a scale
Standard Deviation 2.65
|
-0.9 score on a scale
Standard Deviation 2.96
|
|
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
Week 8
|
-1.6 score on a scale
Standard Deviation 2.96
|
-1.7 score on a scale
Standard Deviation 2.75
|
-0.9 score on a scale
Standard Deviation 3.08
|
|
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
Week 12
|
-1.8 score on a scale
Standard Deviation 3.01
|
-1.7 score on a scale
Standard Deviation 2.66
|
-1.1 score on a scale
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 6, 8, and 12Population: This endpoint was added in protocol amendment 1. All participants randomized after implementing amendment 1 are included. All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
The DLQI is a 10-item scale asking subject to rate the severity of symptoms during the past week. Each item is scored from 0 ("not at all" or "not relevant") to 3 or 4 ("very much") \[2 questions are scored 0 to 3 and 8 questions are scored 0 to 4\]. The total DLQI score ranges from 0 to 48, with higher scores indicating greater symptom severity. The mean (SD) change from baseline DLQI score is presented.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=58 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=60 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=62 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 4
|
-2.2 score on a scale
Standard Deviation 3.46
|
-2.3 score on a scale
Standard Deviation 4.01
|
-1.9 score on a scale
Standard Deviation 4.29
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 6
|
-2.6 score on a scale
Standard Deviation 3.64
|
-3.1 score on a scale
Standard Deviation 4.23
|
-1.8 score on a scale
Standard Deviation 4.23
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 8
|
-2.6 score on a scale
Standard Deviation 3.68
|
-3.5 score on a scale
Standard Deviation 4.57
|
-1.6 score on a scale
Standard Deviation 4.77
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 12
|
-2.6 score on a scale
Standard Deviation 4.48
|
-4.2 score on a scale
Standard Deviation 4.92
|
-1.4 score on a scale
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Weeks 4, 6, 8, and 12Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
Two items from the PSD asking participants to rate the overall severity of psoriasis-related itching and pain during the past 24 hours are presented. Each item is scored on an 11-point scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"), with lower scores indicating lower symptoms severity. The mean (SD) score is presented for each treatment arm.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=109 Participants
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=113 Participants
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=109 Participants
Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 4: Itching
|
3.0 score on a scale
Standard Deviation 2.87
|
3.3 score on a scale
Standard Deviation 2.88
|
4.2 score on a scale
Standard Deviation 3.02
|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 4: Pain
|
1.8 score on a scale
Standard Deviation 2.67
|
1.6 score on a scale
Standard Deviation 2.46
|
2.6 score on a scale
Standard Deviation 2.89
|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 6: Itching
|
2.7 score on a scale
Standard Deviation 2.70
|
2.8 score on a scale
Standard Deviation 2.80
|
4.2 score on a scale
Standard Deviation 2.96
|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 6: Pain
|
1.5 score on a scale
Standard Deviation 2.39
|
1.5 score on a scale
Standard Deviation 2.52
|
2.3 score on a scale
Standard Deviation 2.70
|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 8: Itching
|
2.4 score on a scale
Standard Deviation 2.70
|
2.4 score on a scale
Standard Deviation 2.69
|
4.0 score on a scale
Standard Deviation 2.92
|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 8: Pain
|
1.3 score on a scale
Standard Deviation 2.48
|
1.3 score on a scale
Standard Deviation 2.36
|
2.4 score on a scale
Standard Deviation 2.76
|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 12: Itching
|
2.3 score on a scale
Standard Deviation 2.78
|
2.2 score on a scale
Standard Deviation 2.65
|
4.3 score on a scale
Standard Deviation 3.14
|
|
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Week 12: Pain
|
1.2 score on a scale
Standard Deviation 2.37
|
1.2 score on a scale
Standard Deviation 2.35
|
2.5 score on a scale
Standard Deviation 2.94
|
Adverse Events
Roflumilast Cream 0.3%
Roflumilast Cream 0.15%
Vehicle Cream
Serious adverse events
| Measure |
Roflumilast Cream 0.3%
n=109 participants at risk
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=110 participants at risk
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=107 participants at risk
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Chest pain
|
0.92%
1/109 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.00%
0/110 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.00%
0/107 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/109 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.91%
1/110 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.00%
0/107 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
|
Nervous system disorders
Basal ganglia infarct
|
0.00%
0/109 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.00%
0/110 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.93%
1/107 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/109 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.00%
0/110 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.93%
1/107 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
Other adverse events
| Measure |
Roflumilast Cream 0.3%
n=109 participants at risk
Roflumilast cream 0.3% was topically applied QD for 12 weeks.
|
Roflumilast Cream 0.15%
n=110 participants at risk
Roflumilast cream 0.15% was topically applied QD for 12 weeks.
|
Vehicle Cream
n=107 participants at risk
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
8/109 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
6.4%
7/110 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
0.00%
0/107 • Up to 16 weeks
All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
|
Additional Information
Arcutis Medical Information
Arcutis Biotherapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER