A Phase 3 interventional study of ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% in Atopic Dermatitis Eczema, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 92 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Arcutis Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment
This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 1,220 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Arcutis Biotherapeutics, Inc. is the lead sponsor of 26 studies on the registry; 2 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 20 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants applied ARQ-151 Cream 0.05% once daily (qd) for up to 52 weeks.
Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Also known as: Roflumilast
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
The number of participants with ≥1 TEAE(s) is reported.
Time frame: Up to 52 weeks
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment
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.
Time frame: Weeks 4, 12, 24, 36, and 52
Percentage of Participants With vIGA-AD Success
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.
Time frame: Weeks 4, 12, 24, 36, and 52
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
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.
Time frame: Weeks 4, 12, 24, 36, and 52
Percent Change From Baseline in EASI Score
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.
Time frame: Weeks 4, 12, 24, 36, and 52
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.
| Milestone | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| Started | 439 | 219 | 382 | 180 |
| Completed | 289 | 145 | 254 | 123 |
| Not completed | 150 | 74 | 128 | 57 |
| Withdrew: Withdrawal by subject | 46 | 26 | 37 | 21 |
| Withdrew: Lost to follow-up | 47 | 21 | 30 | 17 |
| Withdrew: Lack of efficacy | 28 | 11 | 37 | 8 |
| Withdrew: Adverse event | 10 | 10 | 10 | 7 |
| Withdrew: Non-compliance | 8 | 3 | 5 | 1 |
| Withdrew: Physician decision | 3 | 0 | 5 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 1 |
| Withdrew: Miscellaneous | 7 | 3 | 4 | 2 |
The number of participants with ≥1 TEAE(s) is reported.
| Participants | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | 151 | 90 | 189 | 91 |
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.
| percentage of participants | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| Week 4 | 40.1 (35.61 to 44.83) | 35.7 (29.60 to 42.36) | 37.7 (32.98 to 42.77) | 40.8 (33.88 to 48.20) |
| Week 12 | 42.2 (37.42 to 47.08) | 36.9 (30.55 to 43.68) | 40.0 (35.10 to 45.07) | 53.0 (45.62 to 60.25) |
| Week 24 | 48.2 (43.25 to 53.18) | 46.3 (39.27 to 53.48) | 46.4 (41.25 to 51.54) | 54.3 (46.72 to 61.75) |
| Week 36 | 45.5 (38.75 to 52.33) | 49.6 (39.36 to 59.82) | 42.5 (37.31 to 47.82) | 47.6 (39.94 to 55.45) |
| Week 52 | 47.9 (40.82 to 55.07) | 45.0 (34.99 to 55.41) | 50.4 (44.86 to 55.99) | 56.9 (48.53 to 64.83) |
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.
| percentage of participants | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| Week 4 | 30.8 (26.65 to 35.33) | 7.8 (4.86 to 12.23) | 28.7 (24.38 to 33.48) | 11.1 (7.32 to 16.57) |
| Week 12 | 33.7 (29.25 to 38.46) | 15.8 (11.46 to 21.48) | 29.5 (25.12 to 34.33) | 24.9 (19.01 to 31.93) |
| Week 24 | 39.7 (35.02 to 44.67) | 21.6 (16.30 to 28.15) | 36.1 (31.31 to 41.13) | 24.1 (18.16 to 31.22) |
| Week 36 | 37.4 (31.01 to 44.30) | 23.5 (15.60 to 33.77) | 34.4 (29.50 to 39.61) | 22.4 (16.45 to 29.70) |
| Week 52 | 42.7 (35.78 to 50.01) | 24.2 (16.20 to 34.53) | 42.5 (37.11 to 48.15) | 28.5 (21.41 to 36.79) |
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.
| WI-NRS Score Change | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| Week 4 | -2.1 ± 2.80 | -0.3 ± 2.23 | — | — |
| Week 12 | -2.4 ± 3.06 | -0.2 ± 2.65 | — | — |
| Week 24 | -2.7 ± 2.85 | -0.8 ± 2.69 | — | — |
| Week 36 | -2.6 ± 2.81 | -0.3 ± 2.40 | — | — |
| Week 52 | -3.2 ± 2.85 | -1.2 ± 2.41 | — | — |
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.
| Percent change in EASI score | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| Week 4 | -63.23 ± 39.702 | -36.93 ± 63.272 | -59.51 ± 40.684 | -41.29 ± 53.042 |
| Week 12 | -68.39 ± 34.195 | -17.95 ± 152.845 | -62.02 ± 49.438 | -16.11 ± 241.787 |
| Week 24 | -72.81 ± 34.462 | -33.34 ± 116.997 | -71.04 ± 36.124 | -32.65 ± 16.532 |
| Week 36 | -73.81 ± 31.300 | -39.20 ± 104.744 | -69.75 ± 40.467 | -39.39 ± 148.094 |
| Week 52 | -74.57 ± 35.160 | -27.94 ± 137.809 | -77.78 ± 35.095 | -52.36 ± 74.751 |
Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARQ-151-311/312: RC/RC 0.15% Group | 0/439 (0%) | 5/439 (1.1%) | 18/439 (4.1%) |
| ARQ-151-311/312: VC/RC 0.15% Group | 0/218 (0%) | 3/218 (1.4%) | 12/218 (5.5%) |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | 0/382 (0%) | 12/382 (3.1%) | 82/382 (21.5%) |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | 0/180 (0%) | 3/180 (1.7%) | 40/180 (22.2%) |
| Event | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 1/439 | 0/218 | 0/382 | 1/180 |
| GastroenteritisInfections and infestations | 1/439 | 0/218 | 0/382 | 1/180 |
| PneumoniaInfections and infestations | 0/439 | 1/218 | 2/382 | 1/180 |
| Eczema infectedInfections and infestations | 0/439 | 0/218 | 0/382 | 1/180 |
| Skin bacterial infectionInfections and infestations | 0/439 | 0/218 | 0/382 | 1/180 |
| Viral upper respiratory tract infectionInfections and infestations | 0/439 | 0/218 | 0/382 | 1/180 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/439 | 0/218 | 0/382 | 1/180 |
| Joint swellingMusculoskeletal and connective tissue disorders | 0/439 | 0/218 | 0/382 | 1/180 |
| Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders | 0/439 | 0/218 | 1/382 | 1/180 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/439 | 0/218 | 0/382 | 1/180 |
| Event | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 9/439 | 12/218 | 33/382 | 16/180 |
| InfluenzaInfections and infestations | 7/439 | 3/218 | 10/382 | 11/180 |
| NasopharyngitisInfections and infestations | 12/439 | 8/218 | 23/382 | 5/180 |
| PyrexiaGeneral disorders | 4/439 | 1/218 | 18/382 | 10/180 |
| COVID-19Infections and infestations | 18/439 | 12/218 | 13/382 | 5/180 |
One participant discontinued from the VC/RC Group prior to dosing.
| Age, Continuous(years) | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Total |
|---|---|---|---|---|---|
| Mean | 19.4 ± 16.4 | 20.5 ± 17.9 | 3.4 ± 1.11 | 3.4 ± 1.17 | 12.2 ± 14.9 |
| Sex: Female, Male(Participants) | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Total |
|---|---|---|---|---|---|
| Female | 244 | 122 | 185 | 91 | 642 |
| Male | 195 | 96 | 197 | 89 | 577 |
| Ethnicity (NIH/OMB)(Participants) | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 75 | 34 | 70 | 25 | 204 |
| Not Hispanic or Latino | 361 | 182 | 310 | 155 | 1008 |
| Unknown or Not Reported | 3 | 2 | 2 | 0 | 7 |
| Race (NIH/OMB)(Participants) | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 6 | 0 | 1 | 1 | 8 |
| Asian | 63 | 35 | 30 | 15 | 143 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 58 | 31 | 58 | 22 | 169 |
| White | 272 | 139 | 262 | 137 | 810 |
| More than one race | 20 | 7 | 25 | 3 | 55 |
| Unknown or Not Reported | 19 | 6 | 6 | 2 | 33 |
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Studies of the drug tested here: Roflumilast
Arcutis Biotherapeutics, Inc. →