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

NCT ID: NCT04128007

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2020-09-25

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

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

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ARQ-154 foam 0.3%

active

Group Type: EXPERIMENTAL

Roflumilast foam 0.3%

Intervention Type: DRUG

experimental

ARQ foam VehicleRQ-154 foam Vehicle

placebo

Group Type: PLACEBO_COMPARATOR

Vehicle foam

Intervention Type: DRUG

experimental

Interventions

Roflumilast foam 0.3%

experimental

Intervention Type: DRUG

Vehicle foam

experimental

Intervention Type: DRUG

Other Intervention Names

ARQ-154; placebo

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Berk, MD

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics

Locations

Arcutis Biotherapeutics Clinical Site 71

Rogers, Arkansas, United States

Arcutis Biotherapeutics Clinical Site 72

Fremont, California, United States

Arcutis Biotherapeutics Clinical Site 85

San Diego, California, United States

Arcutis Biotherapeutics Clinical Site 21

Cromwell, Connecticut, United States

Arcutis Biotherapeutics Clinical Site 91

Boynton Beach, Florida, United States

Arcutis Biotherapeutics Clinical Site 20

Coral Gables, Florida, United States

Arcutis Biotherapeutics Clinical Site 88

Miami, Florida, United States

Arcutis Biotherapeutics Clinical Site 90

Miami, Florida, United States

Arcutis Biotherapeutics Clinical Site 83

Sweetwater, Florida, United States

Arcutis Biotherapeutics Clinical Site 99

Rolling Meadows, Illinois, United States

Arcutis Biotherapeutics Clinical Site 78

Indianapolis, Indiana, United States

Arcutis Biotherapeutics Clinical Site 95

Plainfield, Indiana, United States

Arcutis Biotherapeutics Clinical Site 77

Louisville, Kentucky, United States

Arcutis Biotherapeutics Clinical Site 79

Covington, Louisiana, United States

Arcutis Biotherapeutics Clinical Site 94

Metairie, Louisiana, United States

Arcutis Biotherapeutics Clinical Site 73

Fridley, Minnesota, United States

Arcutis Biotherapeutics Clinical Site 84

Saint Joseph, Missouri, United States

Arcutis Biotherapeutics Clinical Site 98

Portsmouth, New Hampshire, United States

Arcutis Biotherapeutics Clinical Site 87

High Point, North Carolina, United States

Arcutis Biotherapeutics Clinical Site 96

Bexley, Ohio, United States

Arcutis Biotherapeutics Clinical Site 82

Portland, Oregon, United States

Arcutis Biotherapeutics Clinical Site 80

Broomall, Pennsylvania, United States

Arcutis Biotherapeutics Clinical Site 97

Murfreesboro, Tennessee, United States

Arcutis Biotherapeutics Site 70

Arlington, Texas, United States

Arcutis Biotherapeutics Clinical Site 76

Austin, Texas, United States

Arcutis Biotherapeutics Clinical Site 86

College Station, Texas, United States

Arcutis Biotherapeutics Clinical Site 74

Houston, Texas, United States

Arcutis Biotherapeutics Clinical Site 89

Pflugerville, Texas, United States

Arcutis Biotherapeutics Clinical Site 93

San Antonio, Texas, United States

Arcutis Biotherapeutics Clinical Site 81

Norfolk, Virginia, United States

Arcutis Biotherapeutics Clinical Site 75

Richmond, Virginia, United States

Arcutis Biotherapeutics Clinical Site 51

Kogarah, New South Wales, Australia

Arcutis Biotherapeutics Clinical Site 52

Westmead, New South Wales, Australia

Arcutis Biotherapeutics Clinical Site 54

Hectorville, South Australia, Australia

Arcutis Biotherapeutics Clinical Site 50

East Melbourne, Victoria, Australia

Arcutis Biotherapeutics Clinical Site 11

Pleven, , Bulgaria

Arcutis Biotherapeutics Clinical Site 13

Sevlievo, , Bulgaria

Arcutis Biotherapeutics Clinical Site 14

Sofia, , Bulgaria

Arcutis Biotherapeutics Clinical Site 10

Sofia, , Bulgaria

Arcutis Biotherapeutics Clinical Site 12

Stara Zagora, , Bulgaria

Arcutis Biotherapeutics Clinical Site 64

Calgary, Alberta, Canada

Arcutis Biotherapeutics Clinical Site 61

Barrie, Ontario, Canada

Arcutis Biotherapeutics Clinical Site 60

London, Ontario, Canada

Arcutis Biotherapeutics Clinical Site 62

Peterborough, Ontario, Canada

Arcutis Biotherapeutics Clinical Site 63

Waterloo, Ontario, Canada

Arcutis Biotherapeutics Clinical Site 66

Montreal, Quebec, Canada

Arcutis Biotherapeutics Clinical Site 65

Westmount, Quebec, Canada

Countries

United States; Australia; Bulgaria; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARQ-154-204

Identifier Type: -

Identifier Source: org_study_id