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Plaque PsoriasisPhase 1MUSENCT04279119

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

A Phase 1 study testing ARQ-151- cream 0.3% in people with Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
ARQ-151- cream 0.3%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
12 sitesUnited States
Study dates
10 Mar 2020to 25 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Arcutis Clinical Site 10

    Arlington, Texas, 76011

  • Arcutis Clinical Site 07

    Coral Gables, Florida, 33134

  • Arcutis Clinical Site 03

    Doral, Florida, 33122

  • Arcutis Clinical Site 01

    Dublin, Ohio, 43016

  • Arcutis Clinical Site 11

    Fountain Valley, California, 92708

  • Arcutis Clinical Site 06

    Hialeah, Florida, 33016

  • Arcutis Clinical Site 12

    Miami, Florida, 33144

  • Arcutis Clinical Site 02

    Plainfield, Indiana, 46168

  • Arcutis Clinical Site 08

    Richmond, Virginia, 23226

  • Arcutis Clinical Site 09

    Rogers, Arkansas, 72758

  • Arcutis Clinical Site 05

    San Antonio, Texas, 78213

  • Arcutis Clinical Site 04

    Sanford, Florida, 32771

Other trials in United States

About this study

Official title: An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Adolescent and Adult Subjects With Chronic Plaque Psoriasis

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.

Being tested
ARQ-151- cream 0.3%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARQ-151- cream 0.3%Drug

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

Study groups in NCT04279119
Study groupRoleWhat they receive
ARQ-151 cream 0.3%ExperimentalOpen label study of ARQ-151 cream 0.3% applied once daily for 2 weeks
Receives: Drug: ARQ-151- cream 0.3%

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Maximum observed concentration of drug in plasma metabolite

    Measured: 5 weeks

  2. 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.

    Measured: 5 weeks

  3. 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

    Measured: 5 weeks

Secondary outcomes (6)

  1. Subject incidence of adverse events

    Number of participants with adverse events during treatment will be assessed

    Measured: 5 weeks

  2. Incidence of application site reactions

    Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed

    Measured: 5 weeks

  3. Incidence of application site reactions

    Percentage of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed

    Measured: 5 weeks

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

    The C-SSRS is a tool used to assess suicide risk, the severity and immediacy of that risk. The C-SSRS is made up of ten categories and includes questions that require binary responses (yes/no) to indicate a presence or absence of the behavior and follow-up questions for any behavior that is endorsed (yes) to collect additional information.

    Measured: 5 weeks

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

    The PHQ-8 is an instrument used for screening, diagnosing, monitoring and measuring the severity of depression in adults. The score for the PHQ-8 ranges from 0-24 with a higher score reflecting a higher severity category of depression.

    Measured: 5 weeks

  6. The incidence of changes from baseline in the Patient Health Questionnaire for Adolescents (PHQ-A) Depression Scale

    The PHQ-A is an instrument used for screening, diagnosing, monitoring and measuring the severity of depression in adolescents. The score for the PHQ-A ranges from 0-24 with a higher score reflecting a higher severity category of depression.

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start10 Mar 2020
  3. Primary completion25 Mar 2021
  4. Study completion25 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04279119
Sponsor's protocol ID
ARQ-151-107
Acronym
MUSE
Status last verified
Aug 2022
First submitted
15 Jan 2020
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36422852

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ARQ-151- cream 0.3% in people with Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum concentration (Cmax) of roflumilast and its major N-oxide metabolite (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04279119, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.

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