Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

NCT04773587 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-151-311
• Study Type: interventional
• Target: 654
• Locations: 2 countries
• Sites: 49

Brief Summary

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4

  The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.

  Week 4

Secondary Outcomes (10)

• Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores

  Week 4

• Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

  Week 4

• Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

  Week 2

• Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

  Week 1

• Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4

  Week 4

Study Arms (2)

Roflumilast Cream 0.15%

EXPERIMENTAL

Participants with mild to moderate AD apply roflumilast cream 0.15% QD for 4 weeks.

Drug: Roflumilast Cream 0.15%

Vehicle Cream

PLACEBO COMPARATOR

Participants with mild to moderate AD applied vehicle cream QD for 4 weeks.

Drug: Vehicle Cream

Interventions

Roflumilast Cream 0.15% DRUG

Roflumilast Cream 0.15% - Active

Also known as: ARQ-151

Roflumilast Cream 0.15%

Vehicle Cream DRUG

Cream - Vehicle

Vehicle Cream

Eligibility Criteria

• Age: 6 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 sign and give informed consent and, if appropriate, assent as required by local laws.
• Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
• Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
• Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
• In good health as judged by the Investigator.
• Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

You may not qualify if:

• Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
• Has unstable AD or any consistent requirement for high potency topical steroids.
• Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Previous treatment with ARQ-151.
• Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
• Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). 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.
• Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (49)

Arcutis Clinical Site 57

Montgomery, Alabama, 36117, United States

Location

Arcutis Clinical Site 34

Scottsdale, Arizona, 85255, United States

Location

Arcutis Clinical Site 58

Little Rock, Arkansas, 72212, United States

Location

Arcutis Clinical Site 40

Beverly Hills, California, 90212, United States

Location

Arcutis Clinical Site 06

Encinitas, California, 92024, United States

Location

Arcutis Clinical Site 52

Los Angeles, California, 90056, United States

Location

Arcutis Clinical Site 05

San Diego, California, 92123, United States

Location

Arcutis Clinical Site 08

San Francisco, California, 94132, United States

Location

Arcutis Clinical Site 62

Thousand Oaks, California, 91320, United States

Location

Arcutis Clinical Site 30

Coral Gables, Florida, 33134, United States

Location

Arcutis Clinical Site 04

Jacksonville, Florida, 32256, United States

Location

Arcutis Clinical Site 15

Largo, Florida, 33770, United States

Location

Arcutis Clinical Site 39

Miami Lakes, Florida, 33014, United States

Location

Arcutis Clinical Site 38

North Miami Beach, Florida, 33162, United States

Location

Arcutis Clinical Site 01

Tampa, Florida, 33613, United States

Location

Arcutis Clinical Site 61

Wellington, Florida, 33449, United States

Location

Arcutis Clinical Site 26

Sandy Springs, Georgia, 30328, United States

Location

Arcutis Clinical Site 13

Rolling Meadows, Illinois, 33770, United States

Location

Arcutis Clinical Site 48

Clarksville, Indiana, 47129, United States

Location

Arcutis Clinical Site 02

Indianapolis, Indiana, 46250, United States

Location

Arcutis Clinical Site 03

Louisville, Kentucky, 40217, United States

Location

Arcutis Clinical Site 36

Rockville, Maryland, 20850, United States

Location

Arcutis Clinical Site 55

Auburn Hills, Michigan, 48326, United States

Location

Arcutis Clinical Site 54

Bay City, Michigan, 48706, United States

Location

Arcutis Clinical Site 46

Clarkston, Michigan, 48346, United States

Location

Arcutis Clinical Site 37

Detroit, Michigan, 48202, United States

Location

Arcutis Clinical Site 10

New Brighton, Minnesota, 55112, United States

Location

Arcutis Clinical Site 33

Reno, Nevada, 89509, United States

Location

Arcutis Clinical Site 42

East Windsor, New Jersey, 08520, United States

Location

Arcutis Clinical Site 17

Gresham, Oregon, 97030, United States

Location

Arcutis Clinical Site 16

Portland, Oregon, 97223, United States

Location

Arcutis Clinical Site 14

Portland, Oregon, 97239, United States

Location

Arcutis Clinical Site 35

Newtown Square, Pennsylvania, 19073, United States

Location

Arcutis Clinical Site 101

Johnston, Rhode Island, 02919, United States

Location

Arcutis Clinical Site 31

Murfreesboro, Tennessee, 37130, United States

Location

Arcutis Clinical Site 19

Arlington, Texas, 76011, United States

Location

Arcutis Clinical Site 43

Bellaire, Texas, 77401, United States

Location

Arcutis Clinical Site 27

Houston, Texas, 77030, United States

Location

Arcutis Clinical Site 20

Houston, Texas, 77056, United States

Location

Arcutis Clinical Site 28

San Antonio, Texas, 78218, United States

Location

Arcutis Clinical Site 21

South Jordan, Utah, 84095, United States

Location

Arcutis Clinical Site 12

Spokane, Washington, 99202, United States

Location

Arcutis Clinical Site 41

Calgary, Alberta, T2J 7E1, Canada

Location

Arcutis Clinical Site 29

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Arcutis Clinical Site 11

Markham, Ontario, L3P 1X3, Canada

Location

Clinical Site 25

Mississauga, Ontario, L5H 1G9, Canada

Location

Arcutis Clinical Site 32

Peterborough, Ontario, K9J 5K2, Canada

Location

Arcutis Clinical Site 09

Windsor, Ontario, N8W 1E6, Canada

Location

Arcutis Clinical Site 24

Montreal, Quebec, H2X 2V1, Canada

Location

Related Publications (1)

• Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121.

  PMID: 39292443 DERIVED

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: January 27, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Locations

US (42); CA (7)