Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

NCT ID: NCT03916081

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2019-11-04

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.

Conditions

Atopic Dermatitis

Study Design

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

Study Groups

Roflumilast Cream 0.05%

Participants apply roflumilast cream 0.05% QD for 28 days.

Group Type: ACTIVE_COMPARATOR

Roflumilast Cream 0.05%

Intervention Type: DRUG

Roflumilast 0.05% cream for topical application

Roflumilast Cream 0.15%

Participants apply roflumilast cream 0.15% QD for 28 days.

Group Type: ACTIVE_COMPARATOR

Roflumilast Cream 0.15%

Intervention Type: DRUG

Roflumilast 0.15% cream for topical application

Vehicle Cream

Participants apply vehicle cream QD for 28 days.

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Inactive vehicle cream matched to roflumilast cream for topical application.

Interventions

Roflumilast Cream 0.05%

Roflumilast 0.05% cream for topical application

Intervention Type: DRUG

Roflumilast Cream 0.15%

Roflumilast 0.15% cream for topical application

Intervention Type: DRUG

Vehicle Cream

Inactive vehicle cream matched to roflumilast cream for topical application.

Intervention Type: DRUG

Other Intervention Names

ARQ-151; ARQ-151

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.

• 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, Inc.

Locations

Arcutis Clinical Site 25

Scottsdale, Arizona, United States

Arcutis Clinical Site 01

San Diego, California, United States

Arcutis Clinical Site 19

Hialeah, Florida, United States

Arcutis Clinical Site 18

Miami, Florida, United States

Arcutis Clinical Site 17

Sanford, Florida, United States

Arcutis Clinical Site 16

Boise, Idaho, United States

Arcutis Clinical Site 12

Indianapolis, Indiana, United States

Arcutis Clinical Site 13

Plainfield, Indiana, United States

Arcutis Clinical Site 15

Metairie, Louisiana, United States

Arcutis Clinical Site 03

Fridley, Minnesota, United States

Arcutis Clinical Site 02

High Point, North Carolina, United States

Arcutis Clinical Site 08

Bexley, Ohio, United States

Arcutis Clinical Site 23

Pittsburgh, Pennsylvania, United States

Arcutis Clinical Site 20

Murfreesboro, Tennessee, United States

Arcutis Clinical Site 09

College Station, Texas, United States

Arcutis Clinical Site 04

San Antonio, Texas, United States

Arcutis Clinical Site 21

Richmond, Virginia, United States

Arcutis Clinical Site 14

Cobourg, Ontario, Canada

Arcutis Clinical Site 10

Richmond Hill, Ontario, Canada

Arcutis Clinical Site 06

Montreal, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARQ-151-212

Identifier Type: -

Identifier Source: org_study_id