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

  • STATUS
    Recruiting
  • participants needed
    16
  • sponsor
    Arcutis Biotherapeutics, Inc.
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Updated on 19 February 2024
See if I qualify
serum pregnancy test
electrocardiogram
psoriasis vulgaris
psoriasis
12 lead electrocardiogram

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.

Details
Condition Plaque Psoriasis
Age 12years - 100years
Treatment ARQ-151- cream 0.3%
Clinical Study IdentifierNCT04279119
SponsorArcutis Biotherapeutics, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
history of severe depression, suicidal ideation, Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current
Adult subjects with PHQ-8 10 or adolescent subjects with modified PHQ-A 10 at Screening or Baseline visits
Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study
Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. For adolescent subjects; parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language
Subjects who are family members of the clinical study site, clinical study staff, or Sponsor
Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator
Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix
Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days of Baseline/Day 1
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