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

NCT04128007 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ARQ-154-204
• Study Type: interventional
• Target: 304
• Locations: 4 countries
• Sites: 47

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale

  The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.

  Week 8

Secondary Outcomes (6)

• Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8

  Week 8

• Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score

  Baseline and Weeks 2, 4, 8

• Change From Baseline in Psoriasis Symptoms Diary (PSD) Score

  Baseline and Weeks 4 and 8

• Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score

  Up to 8 weeks

• Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)

  Week 8

Study Arms (2)

ARQ-154 foam 0.3%

EXPERIMENTAL

active

Drug: Roflumilast foam 0.3%

ARQ foam VehicleRQ-154 foam Vehicle

PLACEBO COMPARATOR

placebo

Drug: Vehicle foam

Interventions

Roflumilast foam 0.3% DRUG

experimental

Also known as: ARQ-154

ARQ-154 foam 0.3%

Vehicle foam DRUG

experimental

Also known as: placebo

ARQ foam VehicleRQ-154 foam Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (47)

Arcutis Biotherapeutics Clinical Site 71

Rogers, Arkansas, 72758, United States

Location

Arcutis Biotherapeutics Clinical Site 72

Fremont, California, 94538, United States

Location

Arcutis Biotherapeutics Clinical Site 85

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 21

Cromwell, Connecticut, 06416, United States

Location

Arcutis Biotherapeutics Clinical Site 91

Boynton Beach, Florida, 33437, United States

Location

Arcutis Biotherapeutics Clinical Site 20

Coral Gables, Florida, 33134, United States

Location

Arcutis Biotherapeutics Clinical Site 88

Miami, Florida, 33144, United States

Location

Arcutis Biotherapeutics Clinical Site 90

Miami, Florida, 33714, United States

Location

Arcutis Biotherapeutics Clinical Site 83

Sweetwater, Florida, 33172, United States

Location

Arcutis Biotherapeutics Clinical Site 99

Rolling Meadows, Illinois, 60008, United States

Location

Arcutis Biotherapeutics Clinical Site 78

Indianapolis, Indiana, 46250, United States

Location

Arcutis Biotherapeutics Clinical Site 95

Plainfield, Indiana, 46168, United States

Location

Arcutis Biotherapeutics Clinical Site 77

Louisville, Kentucky, 40217, United States

Location

Arcutis Biotherapeutics Clinical Site 79

Covington, Louisiana, 70433, United States

Location

Arcutis Biotherapeutics Clinical Site 94

Metairie, Louisiana, 70006, United States

Location

Arcutis Biotherapeutics Clinical Site 73

Fridley, Minnesota, 55432, United States

Location

Arcutis Biotherapeutics Clinical Site 84

Saint Joseph, Missouri, 64506, United States

Location

Arcutis Biotherapeutics Clinical Site 98

Portsmouth, New Hampshire, 03801, United States

Location

Arcutis Biotherapeutics Clinical Site 87

High Point, North Carolina, 27262, United States

Location

Arcutis Biotherapeutics Clinical Site 96

Bexley, Ohio, 43209, United States

Location

Arcutis Biotherapeutics Clinical Site 82

Portland, Oregon, 97210, United States

Location

Arcutis Biotherapeutics Clinical Site 80

Broomall, Pennsylvania, 19008, United States

Location

Arcutis Biotherapeutics Clinical Site 97

Murfreesboro, Tennessee, 37130, United States

Location

Arcutis Biotherapeutics Site 70

Arlington, Texas, 76011, United States

Location

Arcutis Biotherapeutics Clinical Site 76

Austin, Texas, 78759, United States

Location

Arcutis Biotherapeutics Clinical Site 86

College Station, Texas, 77845, United States

Location

Arcutis Biotherapeutics Clinical Site 74

Houston, Texas, 77056, United States

Location

Arcutis Biotherapeutics Clinical Site 89

Pflugerville, Texas, 78660, United States

Location

Arcutis Biotherapeutics Clinical Site 93

San Antonio, Texas, 78213, United States

Location

Arcutis Biotherapeutics Clinical Site 81

Norfolk, Virginia, 23502, United States

Location

Arcutis Biotherapeutics Clinical Site 75

Richmond, Virginia, 23220, United States

Location

Arcutis Biotherapeutics Clinical Site 51

Kogarah, New South Wales, 2217, Australia

Location

Arcutis Biotherapeutics Clinical Site 52

Westmead, New South Wales, 2145, Australia

Location

Arcutis Biotherapeutics Clinical Site 54

Hectorville, South Australia, 5073, Australia

Location

Arcutis Biotherapeutics Clinical Site 50

East Melbourne, Victoria, 3002, Australia

Location

Arcutis Biotherapeutics Clinical Site 11

Pleven, 5800, Bulgaria

Location

Arcutis Biotherapeutics Clinical Site 13

Sevlievo, 5402, Bulgaria

Location

Arcutis Biotherapeutics Clinical Site 14

Sofia, 1592, Bulgaria

Location

Arcutis Biotherapeutics Clinical Site 10

Sofia, 1606, Bulgaria

Location

Arcutis Biotherapeutics Clinical Site 12

Stara Zagora, 6003, Bulgaria

Location

Arcutis Biotherapeutics Clinical Site 64

Calgary, Alberta, T1Y0B4, Canada

Location

Arcutis Biotherapeutics Clinical Site 61

Barrie, Ontario, L4M 7G1, Canada

Location

Arcutis Biotherapeutics Clinical Site 60

London, Ontario, N6H5L5, Canada

Location

Arcutis Biotherapeutics Clinical Site 62

Peterborough, Ontario, K9J 5K2, Canada

Location

Arcutis Biotherapeutics Clinical Site 63

Waterloo, Ontario, N2J 1C4, Canada

Location

Arcutis Biotherapeutics Clinical Site 66

Montreal, Quebec, H2X 2V1, Canada

Location

Arcutis Biotherapeutics Clinical Site 65

Westmount, Quebec, H3Z 2S6, Canada

Location

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: January 13, 2020
• Primary Completion: September 23, 2020
• Study Completion: September 25, 2020
• Last Updated: October 26, 2022
• Results First Posted: September 30, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (31); CA (7); BU (5); AU (4)