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

Completed · Phase 3

Conditions studied: Atopic Dermatitis Eczema

In brief

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.

Key facts

Study ID

NCT04773600

Run by

Arcutis Biotherapeutics, Inc.

People needed

683

Starts

2021-02-24

Expected to finish

2022-09-29

Last updated by the study team

2024-10-04

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Arcutis Clinical Site 51 — Fort Smith, Arkansas, United States
• Arcutis Clinical Site 46 — Inglewood, California, United States
• Arcutis Clinical Site 19 — San Diego, California, United States
• Arcutis Clinical Site 36 — San Diego, California, United States
• Arcutis Clinical Site 13 — Santa Monica, California, United States
• Arcutis Clinical Site 54 — Centennial, Colorado, United States
• Arcutis Clinical Site 55 — Boca Raton, Florida, United States
• Arcutis Clinical Site 30 — Coral Gables, Florida, United States
• Arcutis Clinical Site 37 — Delray Beach, Florida, United States
• Arcutis Clinical Site 58 — Miami, Florida, United States
• Arcutis Clinical Site 41 — Miami, Florida, United States
• Arcutis Clinical Site 11 — Sanford, Florida, United States
• Arcutis Clinical Site 57 — West Palm Beach, Florida, United States
• Arcutis Clinical Site 62 — Boise, Idaho, United States
• Clinical Site 04 — Plainfield, Indiana, United States
• Arcutis Clinical Site 43 — Louisville, Kentucky, United States
• Arcutis Clinical Site 63 — Baton Rouge, Louisiana, United States
• Arcutis Clinical Site 42 — Lake Charles, Louisiana, United States
• Arcutis Clinical Site 38 — Mandeville, Louisiana, United States
• Arcutis Clinical Site 06 — Metairie, Louisiana, United States
• Arcutis Clinical Site 34 — Rockville, Maryland, United States
• Arcutis Clinical Site 29 — Clinton Township, Michigan, United States
• Arcutis Clinical Site 21 — Fort Gratiot, Michigan, United States
• Arcutis Clinical Site 61 — Troy, Michigan, United States
• Arcutis Clinical Site 31 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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