Trial Outcomes & Findings for Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (NCT NCT04211389)
NCT ID: NCT04211389
Last Updated: 2022-12-07
Results Overview
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
COMPLETED
PHASE3
442 participants
Week 8
2022-12-07
Participant Flow
Adult participants with chronic plaque psoriasis were enrolled at 43 study sites in the United States and Canada.
Participant milestones
| Measure |
Roflumilast Cream 0.3%
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
290
|
152
|
|
Overall Study
COMPLETED
|
264
|
131
|
|
Overall Study
NOT COMPLETED
|
26
|
21
|
Reasons for withdrawal
| Measure |
Roflumilast Cream 0.3%
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
15
|
7
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
Baseline Characteristics
Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Roflumilast Cream 0.3%
n=290 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=152 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Total
n=442 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 15.07 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 14.07 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 14.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
76 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
213 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American-Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
240 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than 1 Race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
76 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
213 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Scores at Baseline
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Scores at Baseline
1 - Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Scores at Baseline
2 - Mild
|
50 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Scores at Baseline
3 - Moderate
|
220 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Scores at Baseline
4 - Severe
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Psoriasis Area Severity Index (PASI) Score
|
6.5 score on a scale
STANDARD_DEVIATION 3.22 • n=5 Participants
|
7.0 score on a scale
STANDARD_DEVIATION 3.52 • n=7 Participants
|
6.7 score on a scale
STANDARD_DEVIATION 3.33 • n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
|
5.8 units on a scale
STANDARD_DEVIATION 2.61 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 2.75 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.66 • n=5 Participants
|
|
Baseline Psoriasis Symptom Diary (PSD) Total Score
|
69.3 score on a scale
STANDARD_DEVIATION 40.66 • n=5 Participants
|
77.4 score on a scale
STANDARD_DEVIATION 41.24 • n=7 Participants
|
72.1 score on a scale
STANDARD_DEVIATION 41.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized participants with data are included.
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=264 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=131 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale
|
99 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 124 days)Population: All randomized participants are included.
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The time to achieve PASI-50 (defined as a 50% reduction from baseline in PASI score) is presented, and is based on observed data only. Participants are included whether they achieved PASI-50 or not.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=290 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=152 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
|
30.0 days
Interval 29.0 to 42.0
|
NA days
Interval 71.0 to
Median number of days and upper bound of CI were not calculable due to low number of cases.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: All randomized participants with data available are included.
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=264 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=131 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Psoriasis Area Severity Index-75 (PASI-75)
|
103 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: All randomized participants with data available are included.
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=290 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=152 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
|
45 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants with intertriginous area involvement and I-IGA score at Baseline ≥ 2 who have Week 8 data available are included.
The number of participants with I-IGA score ≥2 at baseline achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline I-IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=47 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=27 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8
|
32 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants with intertriginous area involvement and I-IGA score at Baseline ≥ 2 who have Week 8 data available are included.
The number of participants achieving an IGA score of 0 ('clear') at Week 8 is presented (observed data only) for each arm. The I-IGA is a 5-point scale assessing the severity of intertriginous area plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=47 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=27 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving I-IGA Score of 'Clear' at Week 8
|
27 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 2, Week 4, Week 8Population: All randomized participants with WI-NRS pruritus score ≥4 at baseline and data available at the relevant time points are included.
The number of participants achieving success in WI-NRS is presented. Success is defined as achievement of a ≥ 4-point reduction in WI-NRS pruritus score in participants with WI-NRS pruritus score ≥ 4 at baseline. The WI-NRS is a 10 point scale ranging from 0 ('no itch') to 10 ('worst itch imaginable') the participant experienced in the past 24 hours, with higher scores indicating greater symptoms severity. Results are based on observed data only.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=215 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=109 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
Week 2
|
90 Participants
|
23 Participants
|
|
Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
Week 4
|
120 Participants
|
23 Participants
|
|
Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
Week 8
|
143 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4 and 8Population: All randomized participants are included.
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. The least squares (LS) mean (95% CI) change in PSD total score relative to baseline is presented for each treatment arm, with decreases from baseline indicating symptom improvement.
Outcome measures
| Measure |
Roflumilast Cream 0.3%
n=290 Participants
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=152 Participants
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
Week 4
|
-42.7 score on a scale
Interval -47.7 to -37.7
|
-16.7 score on a scale
Interval -22.8 to -10.6
|
|
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
Week 8
|
-49.3 score on a scale
Interval -54.8 to -43.7
|
-22.8 score on a scale
Interval -29.6 to -16.0
|
Adverse Events
Roflumilast Cream 0.3%
Vehicle Cream
Serious adverse events
| Measure |
Roflumilast Cream 0.3%
n=290 participants at risk
Participants applied roflumilast cream 0.3% QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
Vehicle Cream
n=152 participants at risk
Participants applied inactive vehicle cream matched to roflumilast cream QD for 8 weeks. There was a 1-week follow-up period after completing treatment.
|
|---|---|---|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/290 • Up to 124 days
All participants who received ≥1 dose of study treatment are included.
|
0.66%
1/152 • Up to 124 days
All participants who received ≥1 dose of study treatment 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. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER