Trial · NCT04804605
Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
NCT04804605, Phase 3, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2025-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis. Trials, record NCT04804605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04804605
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
- NCT number
- NCT04804605
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,220 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Atopic Dermatitis Eczema
- Interventions
- ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
- First posted
- 2021-03-18
- Last updated
- 2025-12-23
- Results first posted
- 2025-12-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | Up to 52 weeks | The number of participants with ≥1 TEAE(s) is reported. |
| Secondary | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Weeks 4, 12, 24, 36, and 52 | 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. |
| Secondary | Percentage of Participants With vIGA-AD Success | Weeks 4, 12, 24, 36, and 52 | 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. |
| Secondary | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Weeks 4, 12, 24, 36, and 52 | 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. |
| Secondary | Percent Change From Baseline in EASI Score | Weeks 4, 12, 24, 36, and 52 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | Up to 52 weeks | All treated participants are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Weeks 4, 12, 24, 36, and 52 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With vIGA-AD Success | Weeks 4, 12, 24, 36, and 52 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Weeks 4, 12, 24, 36, and 52 | All randomized participants who were ≥12 years of age at the start of the parent studies are included. | WI-NRS Score Change | MEAN |
| SECONDARY | Percent Change From Baseline in EASI Score | Weeks 4, 12, 24, 36, and 52 | All randomized participants with data available are included. | Percent change in EASI score | MEAN |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | ARQ-151-311/312: RC/RC 0.15% Group | 151 | Participants | ||
| Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | ARQ-151-311/312: VC/RC 0.15% Group | 90 | Participants | ||
| Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | ARQ-151-315: RC/RC 0.05% or 0.15% Group | 189 | Participants | ||
| Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | ARQ-151-315: VC/RC 0.05% or 0.15% Group | 91 | Participants | ||
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | ARQ-151-311/312: RC/RC 0.15% Group | Week 4 | 40.1 | 95% Confidence Interval 35.61 to 44.83 | percentage of participants |
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | ARQ-151-311/312: VC/RC 0.15% Group | Week 4 | 35.7 | 95% Confidence Interval 29.60 to 42.36 | percentage of participants |
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | ARQ-151-315: RC/RC 0.05% or 0.15% Group | Week 4 | 37.7 | 95% Confidence Interval 32.98 to 42.77 | percentage of participants |
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Week 4 | 40.8 | 95% Confidence Interval 33.88 to 48.20 | percentage of participants |
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | ARQ-151-311/312: RC/RC 0.15% Group | Week 12 | 42.2 | 95% Confidence Interval 37.42 to 47.08 | percentage of participants |
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | ARQ-151-311/312: VC/RC 0.15% Group | Week 12 | 36.9 | 95% Confidence Interval 30.55 to 43.68 | percentage of participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ARQ-151-311/312: RC/RC 0.15% Group | 439 | |
| Overall Study | STARTED | ARQ-151-311/312: VC/RC 0.15% Group | 219 | |
| Overall Study | STARTED | ARQ-151-315: RC/RC 0.05% or 0.15% Group | 382 | |
| Overall Study | STARTED | ARQ-151-315: VC/RC 0.05% or 0.15% Group | 180 | |
| Overall Study | COMPLETED | ARQ-151-311/312: RC/RC 0.15% Group | 289 | |
| Overall Study | COMPLETED | ARQ-151-311/312: VC/RC 0.15% Group | 145 | |
| Overall Study | COMPLETED | ARQ-151-315: RC/RC 0.05% or 0.15% Group | 254 | |
| Overall Study | COMPLETED | ARQ-151-315: VC/RC 0.05% or 0.15% Group | 123 | |
| Overall Study | NOT COMPLETED | ARQ-151-311/312: RC/RC 0.15% Group | 150 | |
| Overall Study | NOT COMPLETED | ARQ-151-311/312: VC/RC 0.15% Group | 74 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | ARQ-151-311/312: RC/RC 0.15% Group | 18 | 439 | |
| other | COVID-19 | Infections and infestations | ARQ-151-311/312: VC/RC 0.15% Group | 12 | 218 | |
| other | COVID-19 | Infections and infestations | ARQ-151-315: RC/RC 0.05% or 0.15% Group | 13 | 382 | |
| other | COVID-19 | Infections and infestations | ARQ-151-315: VC/RC 0.05% or 0.15% Group | 5 | 180 | |
| other | Upper respiratory tract infection | Infections and infestations | ARQ-151-311/312: RC/RC 0.15% Group | 9 | 439 | |
| other | Upper respiratory tract infection | Infections and infestations | ARQ-151-311/312: VC/RC 0.15% Group | 12 | 218 | |
| other | Upper respiratory tract infection | Infections and infestations | ARQ-151-315: RC/RC 0.05% or 0.15% Group | 33 | 382 | |
| other | Upper respiratory tract infection | Infections and infestations | ARQ-151-315: VC/RC 0.05% or 0.15% Group | 16 | 180 | |
| other | Nasopharyngitis | Infections and infestations | ARQ-151-311/312: RC/RC 0.15% Group | 12 | 439 | |
| other | Nasopharyngitis | Infections and infestations | ARQ-151-311/312: VC/RC 0.15% Group | 8 | 218 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARQ-151-311/312: RC/RC 0.15% Group | 0 | 439 |
| Total, all-cause mortality | ARQ-151-311/312: VC/RC 0.15% Group | 0 | 218 |
| Total, all-cause mortality | ARQ-151-315: RC/RC 0.05% or 0.15% Group | 0 | 382 |
| Total, all-cause mortality | ARQ-151-315: VC/RC 0.05% or 0.15% Group | 0 | 180 |
| Total, other adverse events | ARQ-151-311/312: RC/RC 0.15% Group | 18 | 439 |
| Total, other adverse events | ARQ-151-311/312: VC/RC 0.15% Group | 12 | 218 |
| Total, other adverse events | ARQ-151-315: RC/RC 0.05% or 0.15% Group | 82 | 382 |
| Total, other adverse events | ARQ-151-315: VC/RC 0.05% or 0.15% Group | 40 | 180 |
| Total, serious adverse events | ARQ-151-311/312: RC/RC 0.15% Group | 5 | 439 |
| Total, serious adverse events | ARQ-151-311/312: VC/RC 0.15% Group | 3 | 218 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04804605
GET https://conductscience.org/api/trials/v1/NCT04804605/results?page=2