PsoriasisPhase 1NCT07340216
Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis
A Phase 1 study testing ARQ-154 Foam 0.3% in people with Psoriasis, run by Arcutis Biotherapeutics, Inc. at 5 sites in United States.
Trial summary
This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- ARQ-154 Foam 0.3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Dec 2025to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females, ages 2 years to < 12 years old at Day 1.
- Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator.
- Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day 1.
- An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day 1.
- Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day 1.
- Body psoriasis (non-scalp) involving at least 3% BSA on Day 1.
Who cannot join
- Participants who cannot discontinue medications and treatments prior to Day 1 (first application of IP).
- Current diagnosis of non-plaque forms of psoriasis. Current diagnosis of drug-induced psoriasis.
- Participants who have significant active systemic or localized infection or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days prior to Day 1.
- Participants with skin conditions other than psoriasis vulgaris that would interfere with evaluations of the effect of the study medication, as determined by the Investigator.
- Participants who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Day 1 and during the study period.
- A medical history of severe renal insufficiency, moderate to severe hepatic disorders (e.g., Child-Pugh B or C), or chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).
- Participants who are family members of the clinical study staff or sponsor.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Arcutis Clinical Study Site 104
Arlington, Texas, 76011
Arcutis Clinical Study Site 106
Bryant, Arkansas, 72022
Arcutis Clinical Study Site 108
Meridian, Idaho, 83646
Arcutis Clinical Study Site 107
Miami Lakes, Florida, 33014
Arcutis Clinical Study Site 105
West Lafayette, Indiana, 47906
About this study
Official title: An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis
This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
Read the detailed description
ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis.
The goal of the study is to:
- Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%.
- Assess the safety and tolerability of ARQ-154 foam 0.3%
- Conditions
- Psoriasis
- Being tested
- ARQ-154 Foam 0.3%
- Keywords
- Scalp and Body Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-154 Foam 0.3%Drug
ARQ-154 Foam 0.3%
| Study group | Role | What they receive |
|---|---|---|
| ARQ-154 Foam 0.3% | Experimental | ARQ-154 foam 0.3% will be applied QD. Treatment duration will be up to 6 weeks, including 2 weeks under maximal usage conditions, followed by an optional 4 weeks under non-maximal usage conditions. Receives: Drug: ARQ-154 Foam 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Roflumilast and Roflumilast N-Oxide from plasma
Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration.
Measured: 2 Weeks
Participant incidence of adverse events
Number of participants with adverse events during treatment will be assessed
Measured: 6 Weeks
Incidence of application site reactions
Number of participants that experience an application site skin reaction by investigator assessment and participant assessment will be assessed
Measured: 6 Weeks
The incidence of changes from Baseline in the total Children's Depression Inventory 2 (CDI-2)score.
The CDI-2 is an assessment instrument used to evaluate the severity of depressive symptoms in children.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Dec 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340216
- Sponsor's protocol ID
- ARQ-154-127
- Status last verified
- May 2026
- First submitted
- 19 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis
- ClinicalTrials.gov ID
- NCT07340216
- Acronym / sponsor ID
- ARQ-154-127
- Conditions
- Psoriasis
- Keywords
- Scalp and Body Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
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 evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
Detailed description
ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis.
The goal of the study is to:
- Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%.
- Assess the safety and tolerability of ARQ-154 foam 0.3%
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ-154 Foam 0.3% | Experimental | Drug: ARQ-154 Foam 0.3%ARQ-154 foam 0.3% will be applied QD. Treatment duration will be up to 6 weeks, including 2 weeks under maximal usage conditions, followed by an optional 4 weeks under non-maximal usage conditions. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Males and females, ages 2 years to < 12 years old at Day 1.
- Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator.
- Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day 1.
- An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day 1.
- Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day 1.
Key exclusion criteria (7 listed)
- Participants who cannot discontinue medications and treatments prior to Day 1 (first application of IP).
- Current diagnosis of non-plaque forms of psoriasis. Current diagnosis of drug-induced psoriasis.
- Participants who have significant active systemic or localized infection or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days prior to Day 1.
- Participants with skin conditions other than psoriasis vulgaris that would interfere with evaluations of the effect of the study medication, as determined by the Investigator.
- Participants who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Day 1 and 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-154 Foam 0.3%ARQ-154 Foam 0.3% | Drug | ARQ-154 Foam 0.3% |
Primary outcome
Concentration of Roflumilast and Roflumilast N-Oxide from plasma
Time frame: 2 Weeks
Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration.
Participant incidence of adverse events
Time frame: 6 Weeks
Number of participants with adverse events during treatment will be assessed
Incidence of application site reactions
Time frame: 6 Weeks
Number of participants that experience an application site skin reaction by investigator assessment and participant assessment will be assessed
The incidence of changes from Baseline in the total Children's Depression Inventory 2 (CDI-2)score.
Time frame: 6 Weeks
The CDI-2 is an assessment instrument used to evaluate the severity of depressive symptoms in children.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARQ-154 Foam 0.3% in people with Psoriasis, run by Arcutis Biotherapeutics, Inc. at 5 sites in United States.
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 7 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of Roflumilast and Roflumilast N-Oxide from plasma (time frame: 2 Weeks). 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?
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 22 May 2026.