Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Completed · Phase 3

Conditions studied: Atopic Dermatitis Eczema

In brief

This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.

Key facts

Study ID

NCT04804605

Run by

Arcutis Biotherapeutics, Inc.

People needed

1220

Starts

2021-02-25

Expected to finish

2024-05-28

Last updated by the study team

2025-12-23

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.
• Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
• Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. 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.
• Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
• Subjects and parent(s)/legal guardian(s) are 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 who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
• Subjects that use any Excluded Medications and Treatments.
• Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• Subjects with known genetic dermatological conditions that overlap with AD.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), 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 (subjects enrolled in other studies of ARQ-151 cream) living in the same house.

Where it is running

• Arcutis Clinical Site 73 — Birmingham, Alabama, United States
• Arcutis Clinical Site 63 — Scottsdale, Arizona, United States
• Arcutis Clinical Site 106 — Bryant, Arkansas, United States
• Arcutis Clinical Site 116 — Fort Smith, Arkansas, United States
• Arcutis Clinical Site 69 — Beverly Hills, California, United States
• Arcutis Clinical Site 81 — Inglewood, California, United States
• Clinical Site 08 — San Francisco, California, United States
• Arcutis Clinical Site 31 — Santa Monica, California, United States
• Arcutis Clinical Site 130 — Thousand Oaks, California, United States
• Arcutis Clinical Site 123 — Centennial, Colorado, United States
• Arcutis Clinical Site 59 — Coral Gables, Florida, United States
• Arcutis Clinical Site 72 — Coral Gables, Florida, United States
• Arcutis Clinical Site 79 — Delray Beach, Florida, United States
• Arcutis Clinical Site 103 — Hollywood, Florida, United States
• Clinical Site 04 — Jacksonville, Florida, United States
• Arcutis Clinical Site 15 — Largo, Florida, United States
• Arcutis Clinical Site 67 — Miami, Florida, United States
• Arcutis Clinical Site 95 — Miami, Florida, United States
• Arcutis Clinical Site 68 — Miami, Florida, United States
• Arcutis Clinical Site 29 — Sanford, Florida, United States
• Clinical Site 01 — Tampa, Florida, United States
• Arcutis Clinical Site 138 — Wellington, Florida, United States
• Arcutis Clinical Site 47 — Sandy Springs, Georgia, United States
• Arcutis Clinical Site 145 — Boise, Idaho, United States
• Arcutis Clinical Site 112 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.