Trial Outcomes & Findings for Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (NCT NCT04804605)
NCT ID: NCT04804605
Last Updated: 2025-12-23
Results Overview
The number of participants with ≥1 TEAE(s) is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1220 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2025-12-23
Participant Flow
Participants were rolled over upon completion of parent studies ARQ-151-311 (NCT04773587), ARQ-151-312 (NCT03638258), and ARQ-151-315 (NCT04845620). Rollovers from 311/312 were analyzed separately from 315 rollovers.
Participants with atopic dermatitis were enrolled at 153 sites in the United States (US), Canada, and Poland.
Participant milestones
| Measure |
ARQ-151-311/312: RC/RC 0.15% Group
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-311/312: VC/RC 0.15% Group
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
439
|
219
|
382
|
180
|
|
Overall Study
COMPLETED
|
289
|
145
|
254
|
123
|
|
Overall Study
NOT COMPLETED
|
150
|
74
|
128
|
57
|
Reasons for withdrawal
| Measure |
ARQ-151-311/312: RC/RC 0.15% Group
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-311/312: VC/RC 0.15% Group
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
46
|
26
|
37
|
21
|
|
Overall Study
Lost to Follow-up
|
47
|
21
|
30
|
17
|
|
Overall Study
Lack of Efficacy
|
28
|
11
|
37
|
8
|
|
Overall Study
Adverse Event
|
10
|
10
|
10
|
7
|
|
Overall Study
Non-compliance
|
8
|
3
|
5
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
5
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
|
Overall Study
Miscellaneous
|
7
|
3
|
4
|
2
|
Baseline Characteristics
Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
ARQ-151-311/312: RC/RC 0.15% Group
n=439 Participants
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-311/312: VC/RC 0.15% Group
n=218 Participants
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
n=382 Participants
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
n=180 Participants
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
Total
n=1219 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
19.4 years
STANDARD_DEVIATION 16.4 • n=9 Participants
|
20.5 years
STANDARD_DEVIATION 17.9 • n=6 Participants
|
3.4 years
STANDARD_DEVIATION 1.11 • n=9 Participants
|
3.4 years
STANDARD_DEVIATION 1.17 • n=205 Participants
|
12.2 years
STANDARD_DEVIATION 14.9 • n=16 Participants
|
|
Sex: Female, Male
Female
|
244 Participants
n=9 Participants
|
122 Participants
n=6 Participants
|
185 Participants
n=9 Participants
|
91 Participants
n=205 Participants
|
642 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
195 Participants
n=9 Participants
|
96 Participants
n=6 Participants
|
197 Participants
n=9 Participants
|
89 Participants
n=205 Participants
|
577 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
75 Participants
n=9 Participants
|
34 Participants
n=6 Participants
|
70 Participants
n=9 Participants
|
25 Participants
n=205 Participants
|
204 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
361 Participants
n=9 Participants
|
182 Participants
n=6 Participants
|
310 Participants
n=9 Participants
|
155 Participants
n=205 Participants
|
1008 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
7 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
8 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=9 Participants
|
35 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
15 Participants
n=205 Participants
|
143 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=9 Participants
|
31 Participants
n=6 Participants
|
58 Participants
n=9 Participants
|
22 Participants
n=205 Participants
|
169 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
272 Participants
n=9 Participants
|
139 Participants
n=6 Participants
|
262 Participants
n=9 Participants
|
137 Participants
n=205 Participants
|
810 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
55 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
33 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: All treated participants are included.
The number of participants with ≥1 TEAE(s) is reported.
Outcome measures
| Measure |
ARQ-151-311/312: VC/RC 0.15% Group
n=218 Participants
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
n=382 Participants
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
n=180 Participants
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-311/312: RC/RC 0.15% Group
n=439 Participants
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
|---|---|---|---|---|
|
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
|
90 Participants
|
189 Participants
|
91 Participants
|
151 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, and 52Population: All randomized participants are included.
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.
Outcome measures
| Measure |
ARQ-151-311/312: VC/RC 0.15% Group
n=219 Participants
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
n=382 Participants
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
n=180 Participants
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-311/312: RC/RC 0.15% Group
n=439 Participants
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
|---|---|---|---|---|
|
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment
Week 24
|
46.3 percentage of participants
Interval 39.27 to 53.48
|
46.4 percentage of participants
Interval 41.25 to 51.54
|
54.3 percentage of participants
Interval 46.72 to 61.75
|
48.2 percentage of participants
Interval 43.25 to 53.18
|
|
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment
Week 36
|
49.6 percentage of participants
Interval 39.36 to 59.82
|
42.5 percentage of participants
Interval 37.31 to 47.82
|
47.6 percentage of participants
Interval 39.94 to 55.45
|
45.5 percentage of participants
Interval 38.75 to 52.33
|
|
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment
Week 52
|
45.0 percentage of participants
Interval 34.99 to 55.41
|
50.4 percentage of participants
Interval 44.86 to 55.99
|
56.9 percentage of participants
Interval 48.53 to 64.83
|
47.9 percentage of participants
Interval 40.82 to 55.07
|
|
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment
Week 4
|
35.7 percentage of participants
Interval 29.6 to 42.36
|
37.7 percentage of participants
Interval 32.98 to 42.77
|
40.8 percentage of participants
Interval 33.88 to 48.2
|
40.1 percentage of participants
Interval 35.61 to 44.83
|
|
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment
Week 12
|
36.9 percentage of participants
Interval 30.55 to 43.68
|
40.0 percentage of participants
Interval 35.1 to 45.07
|
53.0 percentage of participants
Interval 45.62 to 60.25
|
42.2 percentage of participants
Interval 37.42 to 47.08
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, and 52Population: All randomized participants are included.
The percentage of participants with vIGA-AD "success" is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.
Outcome measures
| Measure |
ARQ-151-311/312: VC/RC 0.15% Group
n=219 Participants
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
n=382 Participants
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
n=180 Participants
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-311/312: RC/RC 0.15% Group
n=439 Participants
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
|---|---|---|---|---|
|
Percentage of Participants With vIGA-AD Success
Week 52
|
24.2 percentage of participants
Interval 16.2 to 34.53
|
42.5 percentage of participants
Interval 37.11 to 48.15
|
28.5 percentage of participants
Interval 21.41 to 36.79
|
42.7 percentage of participants
Interval 35.78 to 50.01
|
|
Percentage of Participants With vIGA-AD Success
Week 24
|
21.6 percentage of participants
Interval 16.3 to 28.15
|
36.1 percentage of participants
Interval 31.31 to 41.13
|
24.1 percentage of participants
Interval 18.16 to 31.22
|
39.7 percentage of participants
Interval 35.02 to 44.67
|
|
Percentage of Participants With vIGA-AD Success
Week 36
|
23.5 percentage of participants
Interval 15.6 to 33.77
|
34.4 percentage of participants
Interval 29.5 to 39.61
|
22.4 percentage of participants
Interval 16.45 to 29.7
|
37.4 percentage of participants
Interval 31.01 to 44.3
|
|
Percentage of Participants With vIGA-AD Success
Week 4
|
7.8 percentage of participants
Interval 4.86 to 12.23
|
28.7 percentage of participants
Interval 24.38 to 33.48
|
11.1 percentage of participants
Interval 7.32 to 16.57
|
30.8 percentage of participants
Interval 26.65 to 35.33
|
|
Percentage of Participants With vIGA-AD Success
Week 12
|
15.8 percentage of participants
Interval 11.46 to 21.48
|
29.5 percentage of participants
Interval 25.12 to 34.33
|
24.9 percentage of participants
Interval 19.01 to 31.93
|
33.7 percentage of participants
Interval 29.25 to 38.46
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, and 52Population: All randomized participants who were ≥12 years of age at the start of the parent studies are included.
Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"), with lower scores indicating reduced symptom severity and vice versa.
Outcome measures
| Measure |
ARQ-151-311/312: VC/RC 0.15% Group
n=139 Participants
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-311/312: RC/RC 0.15% Group
n=256 Participants
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
|---|---|---|---|---|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
Week 52
|
-1.2 WI-NRS Score Change
Standard Deviation 2.41
|
—
|
—
|
-3.2 WI-NRS Score Change
Standard Deviation 2.85
|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
Week 4
|
-0.3 WI-NRS Score Change
Standard Deviation 2.23
|
—
|
—
|
-2.1 WI-NRS Score Change
Standard Deviation 2.80
|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
Week 12
|
-0.2 WI-NRS Score Change
Standard Deviation 2.65
|
—
|
—
|
-2.4 WI-NRS Score Change
Standard Deviation 3.06
|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
Week 24
|
-0.8 WI-NRS Score Change
Standard Deviation 2.69
|
—
|
—
|
-2.7 WI-NRS Score Change
Standard Deviation 2.85
|
|
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
Week 36
|
-0.3 WI-NRS Score Change
Standard Deviation 2.40
|
—
|
—
|
-2.6 WI-NRS Score Change
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, and 52Population: All randomized participants with data available are included.
EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Outcome measures
| Measure |
ARQ-151-311/312: VC/RC 0.15% Group
n=219 Participants
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
n=382 Participants
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
n=180 Participants
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-311/312: RC/RC 0.15% Group
n=439 Participants
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
|---|---|---|---|---|
|
Percent Change From Baseline in EASI Score
Week 4
|
-36.93 Percent change in EASI score
Standard Deviation 63.272
|
-59.51 Percent change in EASI score
Standard Deviation 40.684
|
-41.29 Percent change in EASI score
Standard Deviation 53.042
|
-63.23 Percent change in EASI score
Standard Deviation 39.702
|
|
Percent Change From Baseline in EASI Score
Week 12
|
-17.95 Percent change in EASI score
Standard Deviation 152.845
|
-62.02 Percent change in EASI score
Standard Deviation 49.438
|
-16.11 Percent change in EASI score
Standard Deviation 241.787
|
-68.39 Percent change in EASI score
Standard Deviation 34.195
|
|
Percent Change From Baseline in EASI Score
Week 24
|
-33.34 Percent change in EASI score
Standard Deviation 116.997
|
-71.04 Percent change in EASI score
Standard Deviation 36.124
|
-32.65 Percent change in EASI score
Standard Deviation 16.532
|
-72.81 Percent change in EASI score
Standard Deviation 34.462
|
|
Percent Change From Baseline in EASI Score
Week 36
|
-39.20 Percent change in EASI score
Standard Deviation 104.744
|
-69.75 Percent change in EASI score
Standard Deviation 40.467
|
-39.39 Percent change in EASI score
Standard Deviation 148.094
|
-73.81 Percent change in EASI score
Standard Deviation 31.300
|
|
Percent Change From Baseline in EASI Score
Week 52
|
-27.94 Percent change in EASI score
Standard Deviation 137.809
|
-77.78 Percent change in EASI score
Standard Deviation 35.095
|
-52.36 Percent change in EASI score
Standard Deviation 74.751
|
-74.57 Percent change in EASI score
Standard Deviation 35.160
|
Adverse Events
ARQ-151-311/312: RC/RC 0.15% Group
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
ARQ-151-311/312: VC/RC 0.15% Group
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
ARQ-151-315: RC/RC 0.05% or 0.15% Group
Serious events: 12 serious events
Other events: 82 other events
Deaths: 0 deaths
ARQ-151-315: VC/RC 0.05% or 0.15% Group
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARQ-151-311/312: RC/RC 0.15% Group
n=439 participants at risk
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-311/312: VC/RC 0.15% Group
n=218 participants at risk
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
n=382 participants at risk
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
n=180 participants at risk
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Appendicitis
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Device related infection
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.46%
1/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.46%
1/218 • Up to 52 weeks
All treated participants are included.
|
0.52%
2/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Sepsis
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Nervous system disorders
Headache
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Vascular disorders
Aortic aneurysm
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Vascular disorders
Hypertension
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.46%
1/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.52%
2/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Injury, poisoning and procedural complications
Abscess jaw
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Application site cellulitis
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Influenza
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
1/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Injury, poisoning and procedural complications
Penetrating abdominal trauma
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.26%
1/382 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/180 • Up to 52 weeks
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/439 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/218 • Up to 52 weeks
All treated participants are included.
|
0.00%
0/382 • Up to 52 weeks
All treated participants are included.
|
0.56%
1/180 • Up to 52 weeks
All treated participants are included.
|
Other adverse events
| Measure |
ARQ-151-311/312: RC/RC 0.15% Group
n=439 participants at risk
Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-311/312: VC/RC 0.15% Group
n=218 participants at risk
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
|
ARQ-151-315: RC/RC 0.05% or 0.15% Group
n=382 participants at risk
Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
ARQ-151-315: VC/RC 0.05% or 0.15% Group
n=180 participants at risk
Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
4.1%
18/439 • Up to 52 weeks
All treated participants are included.
|
5.5%
12/218 • Up to 52 weeks
All treated participants are included.
|
3.4%
13/382 • Up to 52 weeks
All treated participants are included.
|
2.8%
5/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
9/439 • Up to 52 weeks
All treated participants are included.
|
5.5%
12/218 • Up to 52 weeks
All treated participants are included.
|
8.6%
33/382 • Up to 52 weeks
All treated participants are included.
|
8.9%
16/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
12/439 • Up to 52 weeks
All treated participants are included.
|
3.7%
8/218 • Up to 52 weeks
All treated participants are included.
|
6.0%
23/382 • Up to 52 weeks
All treated participants are included.
|
2.8%
5/180 • Up to 52 weeks
All treated participants are included.
|
|
General disorders
Pyrexia
|
0.91%
4/439 • Up to 52 weeks
All treated participants are included.
|
0.46%
1/218 • Up to 52 weeks
All treated participants are included.
|
4.7%
18/382 • Up to 52 weeks
All treated participants are included.
|
5.6%
10/180 • Up to 52 weeks
All treated participants are included.
|
|
Infections and infestations
Influenza
|
1.6%
7/439 • Up to 52 weeks
All treated participants are included.
|
1.4%
3/218 • Up to 52 weeks
All treated participants are included.
|
2.6%
10/382 • Up to 52 weeks
All treated participants are included.
|
6.1%
11/180 • Up to 52 weeks
All treated participants are included.
|
Additional Information
Arcutis Medical Information
Arcutis Biotherapeutics
Phone: +1 (844) 692-6729
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The process of coordinating publication efforts is described in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER