Trial Outcomes & Findings for Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis (NCT NCT04128007)
NCT ID: NCT04128007
Last Updated: 2022-10-26
Results Overview
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
COMPLETED
PHASE2
304 participants
Week 8
2022-10-26
Participant Flow
Participant milestones
| Measure |
Roflumilast Foam 0.3%
Participants applied roflumilast foam 0.3% once daily (QD) for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
104
|
|
Overall Study
COMPLETED
|
177
|
87
|
|
Overall Study
NOT COMPLETED
|
23
|
17
|
Reasons for withdrawal
| Measure |
Roflumilast Foam 0.3%
Participants applied roflumilast foam 0.3% once daily (QD) for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Not reported
|
0
|
2
|
Baseline Characteristics
Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
Baseline characteristics by cohort
| Measure |
Roflumilast Foam 0.3%
n=200 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=104 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 14.22 • n=200 Participants
|
45.0 years
STANDARD_DEVIATION 15.76 • n=104 Participants
|
45.1 years
STANDARD_DEVIATION 14.74 • n=304 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=200 Participants
|
47 Participants
n=104 Participants
|
143 Participants
n=304 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=200 Participants
|
57 Participants
n=104 Participants
|
161 Participants
n=304 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=200 Participants
|
25 Participants
n=104 Participants
|
63 Participants
n=304 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
161 Participants
n=200 Participants
|
79 Participants
n=104 Participants
|
240 Participants
n=304 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=200 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=304 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=200 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=304 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=200 Participants
|
4 Participants
n=104 Participants
|
11 Participants
n=304 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=200 Participants
|
1 Participants
n=104 Participants
|
1 Participants
n=304 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=200 Participants
|
6 Participants
n=104 Participants
|
15 Participants
n=304 Participants
|
|
Race (NIH/OMB)
White
|
180 Participants
n=200 Participants
|
91 Participants
n=104 Participants
|
271 Participants
n=304 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=200 Participants
|
1 Participants
n=104 Participants
|
2 Participants
n=304 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=200 Participants
|
1 Participants
n=104 Participants
|
4 Participants
n=304 Participants
|
|
Scalp Investigator Global Assessment (S-IGA) Baseline Score
0 - clear
|
0 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
0 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
0 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
|
Scalp Investigator Global Assessment (S-IGA) Baseline Score
1 - almost clear
|
0 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
0 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
0 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
|
Scalp Investigator Global Assessment (S-IGA) Baseline Score
2 - mild
|
18 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
14 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
32 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
|
Scalp Investigator Global Assessment (S-IGA) Baseline Score
3 - moderate
|
151 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
80 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
231 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
|
Scalp Investigator Global Assessment (S-IGA) Baseline Score
4 - severe
|
29 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
10 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
39 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments.
|
|
Psoriasis Scalp Severity Index (PSSI) Baseline Score
|
22.4 score on a scale
STANDARD_DEVIATION 12.52 • n=198 Participants • Two participants did not have a baseline PSSI assessment.
|
20.9 score on a scale
STANDARD_DEVIATION 11.70 • n=104 Participants • Two participants did not have a baseline PSSI assessment.
|
21.9 score on a scale
STANDARD_DEVIATION 12.25 • n=302 Participants • Two participants did not have a baseline PSSI assessment.
|
|
Body Investigator Global Assessment (B-IGA) Baseline Score
0 - clear
|
0 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
0 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
0 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
|
Body Investigator Global Assessment (B-IGA) Baseline Score
1 - almost clear
|
0 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
0 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
0 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
|
Body Investigator Global Assessment (B-IGA) Baseline Score
2 - mild
|
69 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
39 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
108 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
|
Body Investigator Global Assessment (B-IGA) Baseline Score
3 - moderate
|
119 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
60 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
179 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
|
Body Investigator Global Assessment (B-IGA) Baseline Score
4 - severe
|
10 Participants
n=198 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
5 Participants
n=104 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
15 Participants
n=302 Participants • Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments.
|
|
Scalp Itch Numeric Rating Scale (SI-NRS) Baseline Score
|
6.4 score on a scale
STANDARD_DEVIATION 2.35 • n=200 Participants
|
6.6 score on a scale
STANDARD_DEVIATION 2.25 • n=104 Participants
|
6.5 score on a scale
STANDARD_DEVIATION 2.31 • n=304 Participants
|
|
Psoriasis Symptom Diary (PSD) Total Baseline Score
|
78.5 units on a scale
STANDARD_DEVIATION 39.92 • n=200 Participants
|
84.3 units on a scale
STANDARD_DEVIATION 38.76 • n=104 Participants
|
80.5 units on a scale
STANDARD_DEVIATION 39.55 • n=304 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized participants with S-IGA score at baseline ≥2 and data available are included.
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=181 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=88 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
|
107 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants with data available and baseline B-IGA score ≥2 are included.
The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=181 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=88 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8
|
73 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8Population: All randomized participants with baseline SI-NRS score ≥4 with data available are included.
The number of participants with a baseline SI-NRS score ≥4 who achieve success (a ≥4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=166 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=90 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
Week 2
|
74 Participants
|
14 Participants
|
|
Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
Week 4
|
98 Participants
|
19 Participants
|
|
Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
Week 8
|
110 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4 and 8Population: All randomized participants are included, with multiple imputation used for missing data.
The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. 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 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=200 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=104 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
Week 4
|
-45.0 score on a scale
Interval -53.8 to -36.1
|
-25.4 score on a scale
Interval -35.2 to -15.6
|
|
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
Week 8
|
-55.0 score on a scale
Interval -64.0 to -46.1
|
-27.5 score on a scale
Interval -37.5 to -17.6
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: All randomized participants are included.
The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. Results are based on observed data only.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=200 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=104 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
|
28.0 days
Interval 17.0 to 29.0
|
NA days
Interval 67.0 to
Median and upper bound of 95% CI were not calculable due to low number of cases.
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants with data available are included.
The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=180 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=87 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)
|
121 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: All randomized participants with data available are included.
The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=180 Participants
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=87 Participants
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving PSSI-90
|
84 Participants
|
3 Participants
|
Adverse Events
Roflumilast Foam 0.3%
Vehicle Foam
Serious adverse events
| Measure |
Roflumilast Foam 0.3%
n=198 participants at risk
Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
Vehicle Foam
n=104 participants at risk
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Reproductive system and breast disorders
Testicular torsion
|
0.51%
1/198 • Number of events 1 • Up to 9 weeks
All participants who received ≥1 dose of study intervention are included.
|
0.00%
0/104 • Up to 9 weeks
All participants who received ≥1 dose of study intervention are included.
|
Other adverse events
Adverse event data not reported
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. Any form of publication that is derived from this study must be submitted to Arcutis, Inc. for review and approval. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER