Trial of PDE4 Inhibition With Roflumilast for the Managem... | NCT04211363

Label	Type	Description	Intervention Names
Rofumilast Cream 0.3%	Experimental	Participants receive roflumilast cream 0.3% once daily for 8 weeks.	Drug: Roflumilast 0.3% cream
Vehicle cream	Placebo Comparator	Participants receive vehicle cream once daily for 8 weeks.	Drug: Vehicle Cream

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast 0.3% cream	Drug	Roflumilast 0.3% cream for topical application.	Rofumilast Cream 0.3%

Measure	Description	Time Frame
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8	The number of participants 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 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 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.	Baseline (Day 1) and Week 8

Measure	Description	Time Frame
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws
Males and females ages 2 years and older (inclusive)
Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Previous treatment with ARQ-151 or its active ingredient
Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation

Facility	Status	City	State	ZIP	Country	Contacts
Arcutis Biotherapeutics Clinical Site 127		Encinitas	California	92024	United States
Arcutis Biotherapeutics Clinical Site 112

PubMed Identifier	Type	Citation	Retractions
41134450	Derived	Papp KA, Del Rosso JQ, Lebwohl MG, Gooderham MJ, Hebert AA, Hong HC, Kircik LH, Pariser DM, Stein Gold L, Strober B, Seal MS, Krupa D, Chu DH, Burnett P, Berk DR, Higham RC. Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3733-3744. doi: 10.1007/s13555-025-01562-4. Epub 2025 Oct 24.
36422852

ID	Title	Description
FG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
FG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 21, 2020	Aug 15, 2022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG000286
- ParticipantsBG001153
- ParticipantsBG002439

Title	Measurements

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000286 ParticipantsBG001153 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000286 ParticipantsBG001153 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
American Indian or Alaska Native	ParticipantsBG000286 ParticipantsBG001153 ParticipantsBG002

Whole Body Investigator Global Assessment (IGA) Baseline Score

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.

Count of Participants

Participants

Title	Denominators	Categories
0 - Clear	ParticipantsBG000286 ParticipantsBG001153 ParticipantsBG002

Intertriginous Area Investigator Global Assessment (I-IGA) Baseline Score

For participants with intertriginous involvement, the I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area. Scores range from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.

Baseline I-IGA assessment was added in protocol amendment 1.

Count of Participants

Participants

Title	Denominators	Categories
0 - Clear	ParticipantsBG00068 ParticipantsBG00133

Baseline Psoriasis Symptom Diary (PSD) Total Baseline Score

All participants with baseline PSD total scores available are included.

Mean

Standard Deviation

score on a scale

Title	Denominators	Categories
	ParticipantsBG000282 ParticipantsBG001150

Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score

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. Higher scores indicate greater symptom severity.

One participant in the Roflumilast Cream 0.3% arm did not have a baseline WI-NRS assessment.

Count of Participants

Participants

Title	Denominators	Categories
0	ParticipantsBG000285 ParticipantsBG001153

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8

The number of participants 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 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 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.

All randomized participants with data available are included.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants	OG000255 OG001132

Title

Denominators

Categories

Title	Measurements
	OG000108 OG0018

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	IGA Success Odds Ratio	Cochran-Mantel-Haenszel	Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.	<0.0001		Odds Ratio (OR)	20.69			2-Sided	95	7.58	56.48			Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data..		Superiority

Secondary

Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)

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.

All randomized participants are included.

Posted

Median

95% Confidence Interval

days

From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 days)

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants

Secondary

Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)

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.

All randomized participants with data available at Week 8 are included.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants

Secondary

Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)

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 0 (no disease) to 72 (maximal disease) [higher scores indicate 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.

All randomized participants with data available at Week 8 are included.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants

Secondary

Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8

The number of participants achieving I-IGA success at Week 8 is presented. Success is defined as achievement of I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8 PLUS a ≥2-grade improvement in score from Baseline. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater symptom severity. Participant counts are based on observed data only.

All randomized participants with intertriginous area involvement an I-IGA score at Baseline ≥ 2 and who have Week 8 data available are included.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants

Secondary

Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8

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 plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'); higher scores indicate greater symptom severity.

All randomized participants with intertriginous area involvement an I-IGA score at Baseline ≥ 2 and who have Week 8 data available are included.

Posted

Count of Participants

Participants

Week 8

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success

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'), with higher scores indicating greater symptoms severity. Results are based on observed data only.

All randomized participants with WI-NRS pruritus score ≥4 at baseline and data available at the relevant time points are included.

Posted

Count of Participants

Participants

Baseline (Day 1) and Weeks 2, 4, and 8

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Psoriasis Symptoms Diary (PSD) Score

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.

All randomized participants are included.

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Weeks 4 and 8

ID	Title	Description
OG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
OG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Concussion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected286 at risk EG0010 affected153 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected286 at risk EG0010 affected153 at risk
Deformity thorax	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected286 at risk EG0010 affected153 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected286 at risk EG0011 affected153 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected286 at risk EG0010 affected153 at risk

ID	Title	Description
BG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
BG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rofumilast Cream 0.3%	Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.	0	286	2	286	0	286
EG001	Vehicle Cream	Participants apply vehicle cream topically once daily for 8 weeks.	0	153	1	153	0	153