Trial Outcomes & Findings for Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216) (NCT NCT04746911)

NCT ID: NCT04746911

Last Updated: 2026-08-07

Results Overview

The plasma concentration of roflumilast at Weeks 2 and 4 is reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Weeks 2 and 4: 1 hour predose

Results posted on

2026-08-07

Participant Flow

Pediatric (2 to 5 years of age) participants were enrolled at study sites in the United States, Canada, and Dominican Republic.

Participant milestones

Participant milestones
Measure	Roflumilast Cream 0.3% Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 4 weeks.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Roflumilast Cream 0.3% n=10 Participants Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 4 weeks.
Age, Continuous	3.6 years STANDARD_DEVIATION 1.26 • n=20 Participants
Sex: Female, Male Female	5 Participants n=20 Participants
Sex: Female, Male Male	5 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	9 Participants n=20 Participants
Race (NIH/OMB) White	1 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: Weeks 2 and 4: 1 hour predose

Population: All participants with data available are included.

The plasma concentration of roflumilast at Weeks 2 and 4 is reported.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.3% n=10 Participants Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 4 weeks.
Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3% Week 2	2.15 ng/mL Standard Deviation 1.25
Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3% Week 4	2.04 ng/mL Standard Deviation 1.33

PRIMARY outcome

Timeframe: Weeks 2 and 4: 1 hour predose

Population: All participants with data available are included.

The plasma concentration of the major N-oxide metabolite of roflumilast at Weeks 2 and 4 is reported.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.3% n=10 Participants Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 4 weeks.
Plasma Concentration of Major N-oxide Metabolite Following Daily Application of Roflumilast Cream 0.3% Week 2	22.4 ng/mL Standard Deviation 15.5
Plasma Concentration of Major N-oxide Metabolite Following Daily Application of Roflumilast Cream 0.3% Week 4	15.8 ng/mL Standard Deviation 9.91

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: All treated participants are included.

The number of participants with an AE during the treatment period is reported. An AE is any untoward medical

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.3% n=10 Participants Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 4 weeks.
Number of Participants With an Adverse Event (AE)	1 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: All treated participants are included.

The number of subjects that experience an application site skin reaction by investigator assessment or application site reactions reported as AEs is reported.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.3% n=10 Participants Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 4 weeks.
Number of Participants With Application Site Reactions	0 Participants

Adverse Events

Roflumilast Cream 0.3%

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Roflumilast Cream 0.3% n=10 participants at risk Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 4 weeks.
Nervous system disorders Headache	10.0% 1/10 • Up to 4 weeks All treated participants are included.

Additional Information

Arcutis Medical Information

Arcutis Biotherapeutics

Phone: +1 (844) 692-6729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
Publication restrictions are in place

Restriction type: OTHER