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Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128007
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

Brief Summary:
This study will assess the safety and effIcacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: ARQ-154 Phase 2

Detailed Description:
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: ARQ-154 foam 0.3% Drug: ARQ-154
active vs vehicle

Placebo Comparator: ARQ foam VehicleRQ-154 foam Vehicle Drug: ARQ-154
active vs vehicle




Primary Outcome Measures :
  1. Scalp Investigator Global Assessment Scale [ Time Frame: 8 weeks ]
    Achievement of a Scalp IGA score of 'Clear' or 'Almost Clear' plus a 2-grade improvement from Baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).


Secondary Outcome Measures :
  1. Psoriasis Scalp Severity Index-50 score change [ Time Frame: Week 8 ]
    Achieve a 50% reduction in Psoriasis Scalp Severity Index (PSSI) from Baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.

  2. Psoriasis Scalp Severity Index-score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Time to Psoriasis Scalp Severity Index (PSSI)-50. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.

  3. Psoriasis Area Severity Index-50 score change [ Time Frame: Week 8 ]
    Achieve a 50% reduction in Psoriasis Area Severity Index (PASI) from Baseline. PASI combines the assessment of the severity of lesions and the area affected into single score in the range of 0 (no disease) to 72 (maximal disease). The body is divided into 4 sections (head, arms, trunk, legs); each area is scored by itself and scores are combined into the final PASI. For each section, the percent of area of skin involved is estimated: 0 (0%) to 6 (90% - 100%). For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

  4. Psoriasis Area Severity Index-50 score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Time to Psoriasis Area Severity Index (PASI)-50. PASI combines the assessment of the severity of lesions and the area affected into single score in the range of 0 (no disease) to 72 (maximal disease). The body is divided into 4 sections (head, arms, trunk, legs); each area is scored by itself and scores are combined into the final PASI. For each section, the percent of area of skin involved is estimated: 0 (0%) to 6 (90% - 100%). For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

  5. Psoriasis Scalp Severity Index-75 score change [ Time Frame: Week 8 ]
    Achieve a 75% reduction in Psoriasis Scalp Severity Index (PSSI) from Baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.

  6. Psoriasis Scalp Severity Index-75 score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Time to Psoriasis Scalp Severity Index (PSSI)-75. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.

  7. Scalp Itch Numerical Rating Score score change [ Time Frame: Weeks 2, 4, 8 ]
    For subjects with a Baseline Scalp Itch Numerical Rating Score (SI-NRS) of > 4, achievement of a > 4-point improvement from Baseline at Weeks 2, 4, and 8. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").

  8. Psoriasis Symptoms Diary score change [ Time Frame: Weeks 4 and 8 ]
    Change from Baseline in total Psoriasis Symptoms Diary (PSD) score at Weeks 4 and 8. The PSD is a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws.
  • Males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents).
  • Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Mild ('2') at Baseline.
  • A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline.
  • A PASI score of at least 2 (excluding the palms and soles) at Baseline.
  • Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
  • 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).
  • Females of non-childbearing potential must either be 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, serum chemistry labs, hematology values, and urinalysis.
  • Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria:

  • Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
  • Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other 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 forms of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, 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-154.
  • Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
  • Subjects who cannot discontinue the use of 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 (Visit 2) and during the study.
  • Subjects with PHQ-8 >/= 10 or modified PHQ-A >/= 10 at Screening or Baseline.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • 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.
  • Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of the 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.
  • 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 0.
  • Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128007


Contacts
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Contact: David Berk, MD 805-418-5006 ext 5 studyinquiry@arcutis.com

Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.

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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04128007    
Other Study ID Numbers: ARQ-154-204
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases