Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Adolescents and Adults With Chronic Plaque Psoriasis

NCT04279119 | Completed Phase 1 FDA Drug

• 1 other identifier: ARQ-151-107
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 12

Brief Summary

This is a phase 1, open label, single arm study in which ARQ-151 cream 0.3% is applied QD for 2 weeks to adolescent subjects with chronic plaque psoriasis involving at least 10% body surface area (BSA) and adult subjects with chronic plaque psoriasis involving at least 20% BSA (excluding scalp). The objectives of this study are to evaluate the exposure and characterize the plasma pharmacokinetic profile and to assess the safety and tolerability of ARQ-151 cream 0.3% administered once daily for 2 weeks to adolescent and adult subjects with chronic plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• Maximum concentration (Cmax) of roflumilast and its major N-oxide metabolite

  Maximum observed concentration of drug in plasma metabolite

  5 weeks

• Area under the plasma concentration-time curve until the last quantifiable timepoint (AUC) for roflumilast and its N-oxide metabolite

  The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.

  5 weeks

• Time of maximum concentration (Tmax) of roflumilast and its major N-oxide metabolite

  Tmax is the time that a drug achieves maximum concentration in plasma

  5 weeks

Secondary Outcomes (6)

• Subject incidence of adverse events

  5 weeks

• Incidence of application site reactions

  5 weeks

• Incidence of application site reactions

  5 weeks

• The incidence of suicide ideation as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)

  5 weeks

• The incidence of changes from baseline in the Patient Health Questionnaire (PHQ-8) Depression Scale

  5 weeks

Study Arms (1)

ARQ-151 cream 0.3%

EXPERIMENTAL

Open label study of ARQ-151 cream 0.3% applied once daily for 2 weeks

Drug: ARQ-151- cream 0.3%

Interventions

ARQ-151- cream 0.3% DRUG

ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 2 weeks

ARQ-151 cream 0.3%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants legally competent to sign and give informed consent or for adolescents assent with consent of a parent or legal guardian.
• Males and females ages 12 years and older (inclusive) at the time of consent/assent.
• Clinical diagnosis of psoriasis vulgaris of at least 3 months duration as determined by the Investigator or through subject interview. Stable disease for the past 4 weeks.
• Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 10% of BSA in adolescents and at least 20% of BSA in adults (excluding the scalp).
• An Investigator Global Assessment of disease severity of at least Moderate ('3') at Baseline.
• 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 trial.
• Females of non-childbearing potential should be premenarchal, post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
• Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, 12-lead electrocardiogram, serum chemistry labs, hematology values, and urinalysis.
• Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

You may not qualify if:

• Subjects who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 1).
• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other light emitting diode (LED).
• Subjects currently taking lithium or antimalarial drugs.
• Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).
• Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, 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.
• Known allergies to excipients in ARQ-151 cream
• Subjects who cannot discontinue the use of systemic strong P 450 cytochrome inhibitors (e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, fluconazole, nefazodone, saquinavir, suboxone and telithromycin) for two weeks prior to the Baseline visit and during the study period.
• Subjects who cannot discontinue the use of systemic strong P 450 cytochrome inducers (e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin and carbamazepine) for two weeks prior to the Baseline visit and during the study period.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE4 inhibitors (apremilast) within the past 4 weeks.
• Known or suspected:
• severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C)
• known HIV infection
• hypersensitivity to component(s) of the investigational products

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (12)

Arcutis Clinical Site 09

Rogers, Arkansas, 72758, United States

Location

Arcutis Clinical Site 11

Fountain Valley, California, 92708, United States

Location

Arcutis Clinical Site 07

Coral Gables, Florida, 33134, United States

Location

Arcutis Clinical Site 03

Doral, Florida, 33122, United States

Location

Arcutis Clinical Site 06

Hialeah, Florida, 33016, United States

Location

Arcutis Clinical Site 12

Miami, Florida, 33144, United States

Location

Arcutis Clinical Site 04

Sanford, Florida, 32771, United States

Location

Arcutis Clinical Site 02

Plainfield, Indiana, 46168, United States

Location

Arcutis Clinical Site 01

Dublin, Ohio, 43016, United States

Location

Arcutis Clinical Site 10

Arlington, Texas, 76011, United States

Location

Arcutis Clinical Site 05

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 08

Richmond, Virginia, 23226, United States

Location

Related Publications (1)

• Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.

  PMID: 36422852 DERIVED

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 20, 2020
• Study Start: March 10, 2020
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (12)