Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

NCT04773600 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-151-312
• Study Type: interventional
• Target: 683
• Locations: 2 countries
• Sites: 53

Brief Summary

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.

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

• vIGA-AD Success at Week 2

  Week 2

• vIGA-AD Success at Week 1

  Week 1

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

  Week 4

• Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4

  Week 2

Study Arms (2)

Roflumilast Cream 0.15%

EXPERIMENTAL

Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks.

Drug: Roflumilast Cream

Vehicle Cream

PLACEBO COMPARATOR

Participants apply vehicle cream qd for 4 weeks.

Drug: Vehicle cream

Interventions

Roflumilast Cream DRUG

Roflumilast cream 0.15% for topical application

Also known as: ARQ-151

Roflumilast Cream 0.15%

Vehicle cream DRUG

Vehicle cream for topical application

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 (53)

Arcutis Clinical Site 31

Birmingham, Alabama, 35244, United States

Location

Arcutis Clinical Site 51

Fort Smith, Arkansas, 72916, United States

Location

Arcutis Clinical Site 46

Inglewood, California, 90301, United States

Location

Arcutis Clinical Site 19

San Diego, California, 92123, United States

Location

Arcutis Clinical Site 36

San Diego, California, 92123, United States

Location

Arcutis Clinical Site 13

Santa Monica, California, 90404, United States

Location

Arcutis Clinical Site 54

Centennial, Colorado, 80112, United States

Location

Arcutis Clinical Site 55

Boca Raton, Florida, 33486, United States

Location

Arcutis Clinical Site 30

Coral Gables, Florida, 33146, United States

Location

Arcutis Clinical Site 37

Delray Beach, Florida, 33484, United States

Location

Arcutis Clinical Site 58

Miami, Florida, 33137, United States

Location

Arcutis Clinical Site 41

Miami, Florida, 33144, United States

Location

Arcutis Clinical Site 11

Sanford, Florida, 32771, United States

Location

Arcutis Clinical Site 57

West Palm Beach, Florida, 33406, United States

Location

Arcutis Clinical Site 62

Boise, Idaho, 83706, United States

Location

Clinical Site 04

Plainfield, Indiana, 46168, United States

Location

Arcutis Clinical Site 43

Louisville, Kentucky, 40241, United States

Location

Arcutis Clinical Site 63

Baton Rouge, Louisiana, 70808, United States

Location

Arcutis Clinical Site 42

Lake Charles, Louisiana, 70605, United States

Location

Arcutis Clinical Site 38

Mandeville, Louisiana, 70448, United States

Location

Arcutis Clinical Site 06

Metairie, Louisiana, 70006, United States

Location

Arcutis Clinical Site 34

Rockville, Maryland, 20850, United States

Location

Arcutis Clinical Site 29

Clinton Township, Michigan, 48038, United States

Location

Arcutis Clinical Site 21

Fort Gratiot, Michigan, 48059, United States

Location

Arcutis Clinical Site 61

Troy, Michigan, 48084, United States

Location

Arcutis Clinical Site 245

Saint Joseph, Missouri, 64506, United States

Location

Arcutis Clinical Site 53

New York, New York, 11415, United States

Location

Arcutis Clinical Site 39

Rochester, New York, 14623, United States

Location

Arcutis Clinical Site 33

Stony Brook, New York, 11790, United States

Location

Arcutis Clinical Site 01

High Point, North Carolina, 27262, United States

Location

Arcutis Clinical Site 24

Hershey, Pennsylvania, 17033, United States

Location

Arcutis Clinical Site 07

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Clinical Site 35

Charleston, South Carolina, 29407, United States

Location

Arcutis Clinical Site 18

Charleston, South Carolina, 29425, United States

Location

Arcutis Clinical Site 15

North Charleston, South Carolina, 29420, United States

Location

Clinical Site 05

Austin, Texas, 78759, United States

Location

Arcutis Clinical Site 03

College Station, Texas, 77845, United States

Location

Arcutis Clinical Site 59

Frisco, Texas, 75034, United States

Location

Arcutis Clinical Site 250

Grapevine, Texas, 76051, United States

Location

Arcutis Clinical Site 52

Pflugerville, Texas, 78660, United States

Location

Arcutis Clinical Site 02

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 32

Orem, Utah, 84058, United States

Location

Arcutis Clinical Site 22

Burke, Virginia, 22015, United States

Location

Arcutis Clinical Site 17

Norfolk, Virginia, 23502, United States

Location

Arcutis Clinical Site 12

Calgary, Alberta, T2G 1B1, Canada

Location

Arcutis Clinical Site 09

Surrey, British Columbia, V3R 6A7, Canada

Location

Arcutis Clinical Site 26

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Arcutis Clinical Site 20

Ajax, Ontario, L1S 7K8, Canada

Location

Arcutis Clinical Site 23

London, Ontario, N6H 5L5, Canada

Location

Arcutis Clinical Site 25

Toronto, Ontario, M4W 2N4, Canada

Location

Arcutis Clinical Site 16

Waterloo, Ontario, N2J 1C4, Canada

Location

Arcutis Clinical Site 08

Drummondville, Quebec, J2B 5L4, Canada

Location

Arcutis Clinical Site 27

Québec, Quebec, H3Z 2S6, 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: February 24, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-09

Locations

US (44); CA (9)