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

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ClinicalTrials.gov Identifier: NCT04128007
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Arcutis, 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 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 S-IGA score of 'Clear' or 'Almost Clear' plus a 2-grade improvement from Baseline

  2. Body Investigator Global Assessment Scale [ Time Frame: 8 weeks ]
    Achievement of a B-IGA score of 'Clear' or 'Almost Clear' plus a 2-grade improvement from Baseline


Secondary Outcome Measures :
  1. PSSI-50 score change [ Time Frame: Week 8 ]
    Achieve a 50% reduction in PSSI from Baseline

  2. PSSI-score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Time to PSSI-50

  3. PASI-50 score change [ Time Frame: Week 8 ]
    Achieve a 50% reduction in PASI from Baseline

  4. PASI-50 score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Time to PASI-50

  5. PSSI-75 score change [ Time Frame: Week 8 ]
    Achieve a 75% reduction in PSSI from Baseline

  6. PSSI-75 score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Time to PSSI-75

  7. Scalp Itch NRS score change [ Time Frame: Week 8 ]
    For subjects with a Baseline Scalp Itch-NRS score of > 6, achievement of a > 4-point improvement from Baseline at Week 8

  8. PSD score change [ Time Frame: Week 8 ]
    Change from Baseline in total PSD score at Week 8



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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

Sponsors and Collaborators
Arcutis, Inc.

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Responsible Party: Arcutis, Inc.
ClinicalTrials.gov Identifier: NCT04128007     History of Changes
Other Study ID Numbers: ARQ-154-204
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
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