Clinical trial NCT03916081: Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis
Official title: A Phase 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 136
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.

Detailed description: This is a parallel group, double blind, vehicle-controlled study in which roflumilast cream 0.05% or 0.15% or vehicle is applied QD x 28 days to adolescent and adult subjects with atopic dermatitis. A subset of subjects will have serial PK testing, which will include the first few adolescents and adults enrolled in the study.

Eligibility criteria: Inclusion Criteria:

1. Participants legally competent to sign and give informed consent or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws.
2. Males and females ages 12 years and older (inclusive) at the time of consent.
3. Clinical diagnosis of active atopic dermatitis for at least 6 months.
4. BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
5. vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
6. EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.
7. Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial.
8. In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

Exclusion Criteria:

1. Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
2. Evidence of skin conditions other than AD (atopic dermatitis) that would interfere with evaluation of the effect of the study medication.
3. Pregnant or lactating women or women planning to become pregnant during the study.
4. Known allergies to excipients in ARQ-151 cream.
5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
6. Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
7. Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.
8. Known or suspected:

   * severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
   * history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
   * within last 5 years, a history of severe depression, suicidal ideation
9. Previous treatment with ARQ-151.
10. Subjects with a history of chronic alcohol or drug abuse in past 6 months.
11. Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
12. Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
13. Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
14. Subjects with any condition which makes them unsuitable for clinical study participation or are family members of the clinical study site, clinical study staff, sponsor, or family members of enrolled subjects.

Primary outcomes:
measure: Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Percentage Change From Baseline in EASI Total Score
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Mean Change From Baseline in EASI Total Score at Weeks 1 and 2
timeFrame: Baseline and Weeks 1 and 2
measure: Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50)
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90)
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100)
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Mean Change From Baseline in Body Surface Area (BSA) Involvement
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Worse Itch Numerical Rating Score (WI-NRS) Score Change
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
timeFrame: Baseline and Weeks 1, 2, and 4
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arcutis Clinical Site 25
state: Arizona
city: San Diego
country: United States
facility: Arcutis Clinical Site 01
state: California
city: Hialeah
country: United States
facility: Arcutis Clinical Site 19
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 18
state: Florida
city: Sanford
country: United States
facility: Arcutis Clinical Site 17
state: Florida
city: Boise
country: United States
facility: Arcutis Clinical Site 16
state: Idaho
city: Indianapolis
country: United States
facility: Arcutis Clinical Site 12
state: Indiana
city: Plainfield
country: United States
facility: Arcutis Clinical Site 13
state: Indiana
city: Metairie
country: United States
facility: Arcutis Clinical Site 15
state: Louisiana
city: Fridley
country: United States
facility: Arcutis Clinical Site 03
state: Minnesota
city: High Point
country: United States
facility: Arcutis Clinical Site 02
state: North Carolina
city: Bexley
country: United States
facility: Arcutis Clinical Site 08
state: Ohio
city: Pittsburgh
country: United States
facility: Arcutis Clinical Site 23
state: Pennsylvania
city: Murfreesboro
country: United States
facility: Arcutis Clinical Site 20
state: Tennessee
city: College Station
country: United States
facility: Arcutis Clinical Site 09
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 04
state: Texas
city: Richmond
country: United States
facility: Arcutis Clinical Site 21
state: Virginia
city: Cobourg
country: Canada
facility: Arcutis Clinical Site 14
state: Ontario
city: Richmond Hill
country: Canada
facility: Arcutis Clinical Site 10
state: Ontario
city: Montréal
country: Canada
facility: Arcutis Clinical Site 06
state: Quebec
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: