Clinical trial NCT03764475: Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis
Official title: A Phase 2, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects With Chronic Plaque Psoriasis Who Have Completed Preceding Study ARQ-151-201 Phase 2 Randomized Controlled Trial (Cohort 1) and Non-ARQ-151-201 Subjects (Cohort 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-05
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Note: Subjects that consent to enter this open-label safety study have previously completed a companion study (ARQ-151-201 Phase 2 randomized controlled trial)
Primary purpose: TREATMENT

Brief summary: This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Detailed description: Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201 (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in ARQ-151-201.

Eligibility criteria: Inclusion Criteria:

1. Participants legally competent to sign and give informed consent
2. Males and females ages 18 years and older
3. Subjects with chronic plaque psoriasis who met eligibility criteria for ARQ-151-201, successfully completed ARQ-151-201 through Week 12, and are able to enroll into this long-term safety study on the Week 12 visit of the previous study (ARQ-151-201).
4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial. Highly effective forms of contraception include: oral/implant/injectable/transdermal contraceptives, intrauterine device, or partner's vasectomy. If barrier methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms of conception are required. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and a backup method has been identified if the subject becomes sexually active.
5. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).

Exclusion Criteria:

1. Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in Study ARQ-151-201.
2. Subjects that use any Excluded Medications and Treatments
3. Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular psoriasis.
4. 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 during the study period.
5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin during the study period.
6. Known or suspected:

   * severe renal insufficiency or severe hepatic disorders
   * hypersensitivity to component(s) of the investigational products
   * history of severe depression, suicidal ideation
7. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
8. 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.
9. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
10. 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.
11. 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.

Primary outcomes:
measure: Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to 52 weeks
measure: Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
timeFrame: Weeks 12, 24, 36, and 52
measure: Duration of Response in Participants Achieving 'Clear' IGA Score
timeFrame: Up to 52 weeks
measure: Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear'
timeFrame: Weeks 12, 24, 36, and 52
measure: Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75)
timeFrame: Baseline and Weeks 12, 24, 36, and 52
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Arcutis Clinical Site 35
state: California
city: Northridge
country: United States
facility: Arcutis Clinical Site 29
state: California
city: San Diego
country: United States
facility: Arcutis Clinical Site 28
state: California
city: Santa Monica
country: United States
facility: Arcutis Clinical Site 27
state: California
city: Miami
country: United States
facility: Arcutis Clinical Site 12
state: Florida
city: Sanford
country: United States
facility: Arcutis Clinical Site 16
state: Florida
city: Louisville
country: United States
facility: Arcutis Clinical Site 21
state: Kentucky
city: Clinton Township
country: United States
facility: Arcutis Clinical Site 34
state: Michigan
city: Detroit
country: United States
facility: Arcutis Clinical Site 33
state: Michigan
city: Fridley
country: United States
facility: Arcutis Clinical Site 20
state: Minnesota
city: New York
country: United States
facility: Arcutis Clinical Site 22
state: New York
city: High Point
country: United States
facility: Arcutis Clinical Site 14
state: North Carolina
city: Bexley
country: United States
facility: Arcutis Clinical Site 39
state: Ohio
city: Pittsburgh
country: United States
facility: Arcutis Clinical Site 15
state: Pennsylvania
city: College Station
country: United States
facility: Arcutis Clinical Site 19
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 37
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 13
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 23
state: Texas
city: Webster
country: United States
facility: Arcutis Clinical Site 24
state: Texas
city: Norfolk
country: United States
facility: Arcutis Clinical Site 31
state: Virginia
city: Surrey
country: Canada
facility: Arcutis Clinical Site 18
state: British Columbia
city: Surrey
country: Canada
facility: Arcutis Clinical Site 11
state: British Columbia
city: Winnipeg
country: Canada
facility: Arcutis Clinical Site 38
state: Manitoba
city: Ajax
country: Canada
facility: Arcutis Clinical Site 10
state: Ontario
city: London
country: Canada
facility: Arcutis Clinical Site 25
state: Ontario
city: Markham
country: Canada
facility: Arcutis Clinical Site 26
state: Ontario
city: Oakville
country: Canada
facility: Arcutis Clinical Site 32
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Clinical Site 17
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Clinical Site 30
state: Ontario
city: Windsor
country: Canada
facility: Arcutis Clinical Site 36
state: Ontario
Study officials:
affiliation: Arcutis Biotherapeutics
name: David Berk, MD
role: STUDY_DIRECTOR
References: