Chronic Plaque PsoriasisPhase 3DERMIS-2NCT04211389
Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
A Phase 3 study testing ARQ-151 0.3% cream in people with Chronic Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 39 sites in 2 countries.
Trial summary
This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- ARQ-151 0.3% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 17 Dec 2019to 23 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants legally competent to sign and give informed consented 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.
Who cannot join
- 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
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States31 sites
Arcutis Biotherapeutics Clinical Site 206
Arlington, Texas, 76011
Arcutis Biotherapeutics Clinical Site 239
Beverly Hills, California, 90212
Arcutis Biotherapeutics Clinical Site 223
Boynton Beach, Florida, 91436
Arcutis Biotherapeutics Clinical Site 229
Broomall, Pennsylvania, 19008
Arcutis Biotherapeutics Clinical Site 237
DeLand, Florida, 32720
Arcutis Biotherapeutics Clinical Site 212
Detroit, Michigan, 48202
Arcutis Biotherapeutics Clinical Site 225
Encino, California, 91436
Arcutis Biotherapeutics Clinical Site 216
Fridley, Minnesota, 55432
Arcutis Biotherapeutics Clinical Site 238
Houston, Texas, 77030
Arcutis Biotherapeutics Clinical Site 214
Indianapolis, Indiana, 46250
Arcutis Biotherapeutics Clinical Site 233
Knoxville, Tennessee, 37922
Arcutis Biotherapeutics Clinical Site 211
Lake Charles, Louisiana, 70605
Arcutis Biotherapeutics Clinical Site 228
Largo, Florida, 33770
Arcutis Biotherapeutics Clinical Site 219
Las Vegas, Nevada, 89148
Arcutis Biotherapeutics Clinical Site 231
Las Vegas, Nevada, 89148
Arcutis Biotherapeutics Clinical Site 217
Louisville, Kentucky, 40217
Arcutis Biotherapeutics Clinical Site 213
Metairie, Louisiana, 70006
Arcutis Biotherapeutics Clinical Site 221
Murfreesboro, Tennessee, 37130
Arcutis Biotherapeutics Clinical Site 224
New Orleans, Louisiana, 70115
Arcutis Biotherapeutics Clinical Site 201
North Miami Beach, Florida, 33162
Arcutis Biotherapeutics Clinical Site 222
Oklahoma City, Oklahoma, 73112
Arcutis Biotherapeutics Clinical Site 236
Portsmouth, New Hampshire, 03801
Arcutis Biotherapeutics Clinical Site 240
Reno, Nevada, 89703
Arcutis Biotherapeutics Clinical Site 230
Richmond, Virginia, 23220
Arcutis Biotherapeutics Clinical Site 227
Saint Joseph, Missouri, 64506
Arcutis Biotherapeutics Clinical Site 220
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 208
Santa Monica, California, 90404
Arcutis Biotherapeutics Clinical Site 215
Santa Monica, California, 90503
Arcutis Biotherapeutics Clinical Site 203
Scottsdale, Arizona, 85255
Arcutis Biotherapeutics Clinical Site 209
Sweetwater, Florida, 33172
Arcutis Biotherapeutics Clinical Site 210
West Jordan, Utah, 84088
Canada8 sites
Arcutis Biotherapeutics Clinical Site 205
Ajax, Ontario, L1S 7K8
Arcutis Biotherapeutics Clinical Site 218
Barrie, Ontario, L4M 7G1
Arcutis Biotherapeutics Clinical Site 234
Fredericton, New Brunswick, E3B 1G9
Arcutis Biotherapeutics Clinical Site 207
Surrey, British Columbia, V3R 6A7
Arcutis Biotherapeutics Clinical Site 226
Surrey, British Columbia, V3V0C6
Arcutis Biotherapeutics Clinical Site 235
Toronto, Ontario, M4W 2N2
Arcutis Biotherapeutics Clinical Site 204
Windsor, Ontario, N8W 1E6
Arcutis Biotherapeutics Clinical Site 232
Winnepeg, Manitoba, R3M 3Z4
About this study
Official title: A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis
Read the detailed description
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- ARQ-151 0.3% cream, ARQ-151 vehicle cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-151 0.3% creamDrug
ARQ-151 0.3% cream
ARQ-151 vehicle creamDrug
ARQ-151 vehicle cream
| Study group | Role | What they receive |
|---|---|---|
| ARQ-151 cream 0.3% | Active comparator | Active comparator Receives: Drug: ARQ-151 0.3% cream |
| ARQ-151 cream vehicle | Placebo comparator | Placebo comparator Receives: Drug: ARQ-151 vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (7)
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.
Measured: From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 124 days)
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.
Measured: Baseline (Day 1) and Week 8
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.
Measured: Baseline (Day 1) and Week 8
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.
Measured: Week 8
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.
Measured: Week 8
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.
Measured: Baseline (Day 1) and Week 2, Week 4, Week 8
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.
Measured: Baseline (Day 1) and Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start17 Dec 2019
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Berk, MD, Study director, Arcutis Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211389
- Sponsor's protocol ID
- ARQ-151-302
- Acronym
- DERMIS-2
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2019
- Last updated
- 7 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41134450Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.
PubMed 36422852Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.
PubMed 36125472
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04211389
- Acronym / sponsor ID
- DERMIS-2 / ARQ-151-302
- Conditions
- Chronic Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis
Detailed description
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARQ-151 cream 0.3% | Active comparator | Drug: ARQ-151 0.3% creamActive comparator |
| ARQ-151 cream vehicle | Placebo comparator | Drug: ARQ-151 vehicle creamPlacebo comparator |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants legally competent to sign and give informed consented 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.
Key exclusion criteria (6 listed)
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARQ-151 0.3% creamARQ-151 0.3% cream | Drug | ARQ-151 cream 0.3% |
| ARQ-151 vehicle creamARQ-151 vehicle cream | Drug | ARQ-151 cream vehicle |
Primary outcome
Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale
Time frame: Week 8
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.
7 secondary outcomes
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
Time frame: From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 124 days)
Number of Participants Achieving Psoriasis Area Severity Index-75 (PASI-75)
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8
Time frame: Week 8
Number of Participants Achieving I-IGA Score of 'Clear' at Week 8
Time frame: Week 8
Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
Time frame: Baseline (Day 1) and Week 2, Week 4, Week 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
Time frame: Baseline (Day 1) and Weeks 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41134450Papp 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.
- Derived from this study: PubMed 36422852Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.
- Derived from this study: PubMed 36125472Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Berk, MD study director
Arcutis Biotherapeutics, Inc.
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARQ-151 0.3% cream in people with Chronic Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211389, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.