PsoriasisPhase 2NCT04655313
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)
A Phase 2 study testing ARQ-151 cream 0.3% in people with Psoriasis and Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 17 sites in 3 countries.
Trial summary
This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 6 to 11 years old) with plaque psoriasis: Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Psoriasis, Plaque Psoriasis
- What is being tested?
- ARQ-151 cream 0.3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 30 Nov 2020to 12 Jan 2022
- Phase
- Phase 2
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subject, as required by local laws.
- Males or females, 6 to 11 years old (inclusive).
- Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks.
- Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles).
- An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline.
- Subject has adequate venous access for PK sampling in areas not involved by plaque psoriasis and not being treated with ARQ-151 (e.g., back of the hands).
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- Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the duration of the trial and for one week after application of the last dose.
- Females of non-childbearing potential must be pre-menarchal.
- In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.
- Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and Visit Schedule, according to the judgment of the Investigator.
Who cannot join
- Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris
- Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period.
- Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Baseline/Day 1 and during the study period.
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- Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
- Subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the Baseline/Day 1 and during the study period according to the protocol.
- Subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1.
- Subjects with a CDI-2 (parent report) raw score >20 at Screening/Baseline
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States15 sites
Arcutis Clinical Site 506
Arlington, Texas, 76001
Arcutis Clinical Site 510
Boca Raton, Florida, 33428
Arcutis Clinical Site 502
Coral Gables, Florida, 33146
Arcutis Clinical Site 513
Delray Beach, Florida, 33484
Arcutis Clinical Site 509
Fountain Valley, California, 92708
Arcutis Clinical Site 519
Frisco, Texas, 75034
Arcutis Clinical Site 501
Hialeah, Florida, 33016
Arcutis Clinical Site 505
Houston, Texas, 77030
Arcutis Site 518
Los Angeles, California, 90017
Arcutis Clinical Site 508
Los Angeles, California, 90057
Arcutis Clinical Site 507
Miami, Florida, 33155
Arcutis Clinical Site 503
Mountain Brook, Alabama, 35223
Arcutis Clinical Site 511
Rancho Santa Margarita, California, 92688
Arcutis Clinical Site 504
Scottsdale, Arizona, 85255
Arcutis Clinical Site 527
West Lafayette, Indiana, 47906
About this study
Official title: An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 6 to 11 Years Old) With Plaque Psoriasis
This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 6 to 11 years old) with plaque psoriasis:
- Conditions
- Psoriasis, Plaque Psoriasis
- Being tested
- ARQ-151 cream 0.3%
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-151 cream 0.3%Drug
Also called Topical roflumilast
ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| ARQ-151 cream 0.3% | Experimental | Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks Receives: Drug: ARQ-151 cream 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of ARQ-151 Cream 0.3%
Plasma levels of circulating roflumilast were determined at 2 points in the study.
Measured: Predose on Days 14 and 28
Plasma Concentration of the Roflumilast Major N-oxide Metabolite
Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study.
Measured: Predose on Days 14 and 28
Number of Participants With ≥1 Adverse Event (AE)
The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Measured: Up to 28 days
Number of Participants With Application Site Reactions
The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product.
Measured: Baseline (Day 1), Day 7, and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start30 Nov 2020
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT04655313
- Sponsor's protocol ID
- ARQ-151-215
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2020
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hebert AA, Guide SV, Groysman V, Gonzalez ME, Blanco D, Laquer V, Seal MS, Thurston A, Krupa D, Snyder S, Burnett P, Chu DH, Berk DR, Higham RC. Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years. Pediatr Dermatol. 2026 Jan-Feb;43(1):105-108. doi: 10.1111/pde.70013. Epub 2025 Aug 27.
PubMed 40862624
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 6 to 11 Years Old) With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04655313
- Acronym / sponsor ID
- ARQ-151-215
- Conditions
- Psoriasis, Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 6 to 11 years old) with plaque psoriasis:
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ-151 cream 0.3% | Experimental | Drug: ARQ-151 cream 0.3%Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subject, as required by local laws.
- Males or females, 6 to 11 years old (inclusive).
- Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks.
- Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles).
- An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline.
Key exclusion criteria (10 listed)
- Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris
- Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period.
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 cream 0.3%Also: Topical roflumilastARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks | Drug | ARQ-151 cream 0.3% |
Primary outcome
Plasma Concentration of ARQ-151 Cream 0.3%
Time frame: Predose on Days 14 and 28
Plasma levels of circulating roflumilast were determined at 2 points in the study.
Plasma Concentration of the Roflumilast Major N-oxide Metabolite
Time frame: Predose on Days 14 and 28
Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study.
Number of Participants With ≥1 Adverse Event (AE)
Time frame: Up to 28 days
The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Number of Participants With Application Site Reactions
Time frame: Baseline (Day 1), Day 7, and Day 14
The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40862624Hebert AA, Guide SV, Groysman V, Gonzalez ME, Blanco D, Laquer V, Seal MS, Thurston A, Krupa D, Snyder S, Burnett P, Chu DH, Berk DR, Higham RC. Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years. Pediatr Dermatol. 2026 Jan-Feb;43(1):105-108. doi: 10.1111/pde.70013. Epub 2025 Aug 27.
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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.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ-151 cream 0.3% in people with Psoriasis and Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 17 sites in 3 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 10 inclusion and 10 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, Dominican Republic. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Dec 2023). 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?
Plasma Concentration of ARQ-151 Cream 0.3% (time frame: Predose on Days 14 and 28). The study lists 4 primary outcomes in all. 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 NCT04655313, which also lists 1 linked publication.
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 15 Dec 2023.