ARQ-154 Foam for Psoriasis

Recruiting at 4 trial locations

Overseen By Arcutis Biotherapeutics

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Arcutis Biotherapeutics, Inc.

Must not be taking: Strong CYP3A4 inhibitors

Disqualifiers: Non-plaque psoriasis, Severe renal insufficiency, Moderate to severe hepatic disorders, Chronic infectious disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new foam treatment, ARQ-154, to determine its absorption in the body and identify any side effects in children with psoriasis, a skin condition that causes itchy or scaly patches. The foam treats moderate scalp psoriasis and mild body psoriasis by applying it to the scalp and body. It is suitable for children aged 2 to under 12 who have had psoriasis for at least two months, with noticeable patches on their scalp and body. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that ARQ-154 Foam 0.3% is likely to be safe for humans?

Research has shown that ARQ-154 Foam 0.3% is generally safe. A detailed safety review found no major safety concerns with this foam, meaning earlier studies reported no serious side effects. A thorough study tested the foam's safety over time, confirming its safety. Although this trial remains in the early stages, earlier research's lack of major issues is encouraging for potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

ARQ-154 Foam is unique because it uses a foam formulation to deliver its active ingredient, which sets it apart from other psoriasis treatments like creams, ointments, and systemic medications. This foam can be more convenient and easier to apply, particularly on the scalp and other hairy areas, where traditional treatments can be messy or difficult to use. Researchers are excited about ARQ-154 Foam because it offers a novel delivery method that could potentially improve patient adherence and effectiveness, especially in tough-to-treat areas.

What evidence suggests that ARQ-154 foam might be an effective treatment for psoriasis?

Research has shown that ARQ-154 foam 0.3% may help treat plaque psoriasis. One study found that using the foam once a day for eight weeks led to noticeable improvements compared to a placebo, which contains no active ingredients. Another review suggests that this foam works better than treatments without active ingredients, making it a good choice for managing psoriasis symptoms. Since the foam is not a steroid, it might have fewer side effects than typical steroid creams. These findings suggest that ARQ-154 foam 0.3% could be an effective option for people with psoriasis. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 2 to less than 12 with scalp and body psoriasis diagnosed at least 2 months prior. They must have moderate scalp psoriasis covering at least 10% of the scalp and mild body psoriasis on at least 3% of their body surface area. Kids with severe kidney or liver issues, chronic infections like HIV, or non-plaque psoriasis types cannot join.

Inclusion Criteria

I am between 2 and 11 years old.

I have been diagnosed with psoriasis for at least 2 months.

My scalp psoriasis is at least moderate in severity.

Exclusion Criteria

I do not have severe kidney, serious liver problems, or chronic infections like hepatitis or HIV.

Participants who are family members of the clinical study staff or sponsor

My psoriasis is not the plaque type.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ARQ-154 foam 0.3% applied QD for up to 6 weeks, including 2 weeks under maximal usage conditions

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ARQ-154 Foam 0.3%

Trial Overview

The study tests ARQ-154 Foam 0.3%, focusing on how much gets into the bloodstream (pharmacokinetics) and its safety in kids with scalp and body psoriasis. It will monitor drug levels in plasma and observe any side effects during use.

How Is the Trial Designed?

Group I: ARQ-154 Foam 0.3% Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Arcutis Biotherapeutics, Inc.

Lead Sponsor

Trials

22

Recruited

7,600+

Citations

1.

investors.arcutis.com

investors.arcutis.com/news-releases/news-release-details/arcutis-announces-positive-topline-data-phase-2b-study-arq-154

Arcutis Announces Positive Topline Data from Phase 2b Study ...

Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvements compared to a matching vehicle ...

2.

fda.gov

fda.gov/media/185434/download

Multi-Disciplinary Review and Evaluation sNDA 217242- ...

0.3% Foam in Adolescent and Adult Subjects, Trial ARQ-154-122 ... (ARQ-154-122) conducted with roflumilast foam, 0.3% for psoriasis.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11455807/

Efficacy and Safety of Topical Roflumilast for the Treatment ...

These findings support the superiority of topical roflumilast 0.3% over vehicle and suggest its use as a valuable asset for the treatment of plaque psoriasis.

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/28/NCT04973228/Prot_000.pdf

ARQ-154-304

This study assesses the safety and efficacy of ARQ-154 foam 0.3%. Safety will be determined by evaluating physical examinations, vital signs ...

5.

jamanetwork.com

jamanetwork.com/journals/jamadermatology/fullarticle/2804569

Efficacy of Roflumilast Foam, 0.3%, in Patients With ...

These phase 2a data demonstrate that once-daily roflumilast foam, 0.3%, may be a viable nonsteroidal topical treatment of seborrheic dermatitis.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04128007

NCT04128007 | Safety and Efficacy of ARQ-154 Foam in ...

The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data ...

7.

arcutis.com

arcutis.com/wp-content/uploads/2020/01/ARQ-154-Scalp-Psoriasis-Program-and-204-FPE.pdf

ARQ-154-Scalp-Psoriasis-Program-and- ...

The Phase 2b trial is an 8-week, multi-center, multi-national, double blind, vehicle-controlled, study of the safety and efficacy of ARQ-154 0.3 ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07340216?term=NA

Maximal Usage Pharmacokinetics and Safety Study of ...

The goal of the study is to: Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%.

9.

clinicaltrialsregister.eu

clinicaltrialsregister.eu/ctr-search/trial/2019-003354-92/results

EudraCT Number 2019-003354-92 - Clinical trial results

Clinical Trial Results: A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered ...