Twin Trial of PDE4 Inhibition With Roflumilast for the Ma... | NCT04211389

NCT04211389

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARQ-151 cream 0.3%	Active Comparator	Active comparator	Drug: ARQ-151 0.3% cream
ARQ-151 cream vehicle	Placebo Comparator	Placebo comparator	Drug: ARQ-151 vehicle cream

Name	Type	Description	Arm Group Labels	Other Names
ARQ-151 0.3% cream	Drug	ARQ-151 0.3% cream	ARQ-151 cream 0.3%
ARQ-151 vehicle cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale	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.	Week 8

Secondary Outcomes

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. Participants are included whether they achieved PASI-50 or not.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
David Berk, MD	Arcutis Biotherapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arcutis Biotherapeutics Clinical Site 203		Scottsdale	Arizona	85255	United States
Arcutis Biotherapeutics Clinical Site 239

References Module

Citations

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

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

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, 2019	Jul 10, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

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

Title	Measurements
	BG00046.9± 15.07 BG00147.1± 14.07 BG00247.0± 14.72

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000114 BG00152 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00076 BG00150 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American-Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00076 BG00150 BG002

Investigator Global Assessment (IGA) Scores at Baseline

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

Title	Measurements
	BG0000 BG001

Psoriasis Area Severity Index (PASI) Score

Mean

Standard Deviation

score on a scale

Title

Denominators

Categories

Title	Measurements
	BG0006.5± 3.22 BG001

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

The WI-NRS is a simple, single item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the past 24 hours. Higher scores indicate greater symptom severity.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0005.8± 2.61 BG001

Baseline Psoriasis Symptom Diary (PSD) Total Score

Mean

Standard Deviation

score on a scale

Title

Denominators

Categories

Title	Measurements
	BG00069.3± 40.66 BG001

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 on the Investigator Global Assessment (IGA) Scale

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.

All randomized participants with data are included.

Posted

Count of Participants

Participants

Week 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000264 OG001131

Title

Denominators

Categories

Title	Measurements
	OG00099 OG0019

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 at Week 8 Odds Ratio	Cochran-Mantel-Haenszel		<0.0001	Stratification by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.	Odds Ratio (OR)	6.59			2-Sided	95	3.17	13.70			Common OR 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. Participants are included whether they achieved PASI-50 or not.

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 = 124 days)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

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 are included.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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

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.

All randomized participants with data available are included.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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

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.

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

Posted

Count of Participants

Participants

Week 8

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants Achieving I-IGA Score of 'Clear' 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 intertriginous area plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.

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

Posted

Count of Participants

Participants

Week 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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

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.

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 Week 2, Week 4, Week 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

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

Baseline (Day 1) and Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	290	0	290	0	290
EG001	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.	0	152	1	152	0	152

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cervical radiculopathy	Nervous system disorders	MedDRA (23.0)	Systematic Assessment		EG0000 affected290 at risk EG0011 affected152 at risk

First MCP Posted Date