Trial Outcomes & Findings for Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215) (NCT NCT04655313)

NCT ID: NCT04655313

Last Updated: 2023-12-15

Results Overview

Plasma levels of circulating roflumilast were determined at 2 points in the study.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Predose on Days 14 and 28
• Results posted on: 2023-12-15

Participant Flow

Pediatric participants 6-11 years of age were enrolled at 17 study sites in the United States, Canada, and the Dominican Republic.

Participant milestones

Measure	ARQ-151 Cream 0.3% Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks
Overall Study STARTED	20
Overall Study COMPLETED	20
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-151-215)

Baseline characteristics by cohort

Measure	ARQ-151 Cream 0.3% n=20 Participants Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks
Age, Continuous	8.8 years STANDARD_DEVIATION 1.61 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose on Days 14 and 28

Population: Participants with data available are included.

Plasma levels of circulating roflumilast were determined at 2 points in the study.

Outcome measures

Measure	ARQ-151 Cream 0.3% n=18 Participants Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks
Plasma Concentration of ARQ-151 Cream 0.3% Day 14	3.15 ng/mL Standard Deviation 3.64
Plasma Concentration of ARQ-151 Cream 0.3% Day 28	1.68 ng/mL Standard Deviation 1.57

PRIMARY outcome

Timeframe: Predose on Days 14 and 28

Population: Participants with data available are included.

Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study.

Outcome measures

Measure	ARQ-151 Cream 0.3% n=18 Participants Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks
Plasma Concentration of the Roflumilast Major N-oxide Metabolite Day 14	28.9 ng/mL Standard Deviation 41.1
Plasma Concentration of the Roflumilast Major N-oxide Metabolite Day 28	15.7 ng/mL Standard Deviation 15.8

PRIMARY outcome

Timeframe: Up to 28 days

Population: All treated participants are included.

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.

Outcome measures

Measure	ARQ-151 Cream 0.3% n=20 Participants Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks
Number of Participants With ≥1 Adverse Event (AE)	4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Day 7, and Day 14

Population: All treated participants are included.

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.

Outcome measures

Measure	ARQ-151 Cream 0.3% n=20 Participants Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks
Number of Participants With Application Site Reactions Day 1: No erythema	18 Participants
Number of Participants With Application Site Reactions Day 1: Minimal erythema	0 Participants
Number of Participants With Application Site Reactions Day 1: Definite erythema	1 Participants
Number of Participants With Application Site Reactions Day 7: No erythema	17 Participants
Number of Participants With Application Site Reactions Day 7: Minimal erythema	3 Participants
Number of Participants With Application Site Reactions Day 7: Definite erythema	0 Participants
Number of Participants With Application Site Reactions Day 14: No erythema	19 Participants
Number of Participants With Application Site Reactions Day 14: Minimal erythema	1 Participants
Number of Participants With Application Site Reactions Day 14: Definite erythema	0 Participants

Adverse Events

ARQ-151 Cream 0.3%

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ARQ-151 Cream 0.3% n=20 participants at risk Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks
Infections and infestations Candida infection	5.0% 1/20 • Up to 28 days All treated participants are included.
Injury, poisoning and procedural complications Application site pain	5.0% 1/20 • Up to 28 days All treated participants are included.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Up to 28 days All treated participants are included.
Nervous system disorders Headache	5.0% 1/20 • Up to 28 days All treated participants are included.
Reproductive system and breast disorders Perineal pain	5.0% 1/20 • Up to 28 days All treated participants are included.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 1/20 • Up to 28 days All treated participants are included.
Skin and subcutaneous tissue disorders Dermatitis	5.0% 1/20 • Up to 28 days All treated participants are included.
Skin and subcutaneous tissue disorders Perineal erythema	5.0% 1/20 • Up to 28 days All treated participants are included.

Additional Information

Arcutis Medical Information

Arcutis Biotherapeutics

Phone: +1 (844) 692-6729

Email: medinfo@arcutis.com

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