Clinical trial NCT04445987: Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Official title: A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seborrheic Dermatitis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 408
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)
Primary purpose: TREATMENT

Brief summary: This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.


Eligibility criteria: Inclusion Criteria:

1. Participants legally competent to sign and give informed consent or (for adolescents) assent.
2. Males and females ages 9 years and older (inclusive) at the time of consent.
3. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
4. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.

   Cohort 1 only:
5. Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.

   Cohort 2 subjects that have not participated in a prior ARQ-154 study:
6. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
7. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
8. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
9. Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1.

   Cohort 2 subjects that have participated in a prior ARQ-154 study:
10. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
11. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

Exclusion Criteria:

1. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
2. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
3. Subjects unable to apply investigational product to the scalp due to physical limitation.
4. Known allergies to excipients in ARQ-154 foam.
5. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
6. Known or suspected:

   * severe renal insufficiency or moderate to severe hepatic disorders
   * history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.
7. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
8. Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
9. Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
10. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
11. 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.
12. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects.

    Cohort 1 only:
13. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
14. Subjects that use any Excluded Medication and Treatments.

    Cohort 2 only:
15. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.
16. Subjects with PHQ-8 \>10 or modified PHQ-A \>10 at Screening or Day 1.

    Cohort 2 subjects that have participated in a prior ARQ-154 study:
17. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.

Primary outcomes:
measure: Number of Participants With ≥1 Adverse Event (AE)
timeFrame: Up to 52 weeks
measure: Number of Participants With ≥1 Serious Adverse Event (SAE)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Achievement of IGA Success
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Duration of IGA Success
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: IGA Treatment-Free Interval
timeFrame: Weeks 4, 12, 24, 36, and 52
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Arcutis Biotherapeutics Clinical Site 59
state: California
city: Encino
country: United States
facility: Arcutis Biotherapeutics Clinical Site 51
state: California
city: Fountain Valley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 75
state: California
city: Fremont
country: United States
facility: Arcutis Biotherapeutics Clinical Site 19
state: California
city: Los Angeles
country: United States
facility: Arcutis Biotherapeutics Clinical Site 62
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 64
state: California
city: Santa Monica
country: United States
facility: Arcutis Biotherapeutics Clinical Site 21
state: California
city: Aventura
country: United States
facility: Arcutis Biotherapeutics Clinical Site 53
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Biotherapeutics Clinical Site 42
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 57
state: Florida
city: Miami
country: United States
facility: Arcutis Biotherapeutics Clinical Site 24
state: Florida
city: Sanford
country: United States
facility: Arcutis Biotherapeutics Clinical Site 65
state: Florida
city: Tampa
country: United States
facility: Arcutis Biotherapeutics Clinical Site 12
state: Florida
city: Rolling Meadows
country: United States
facility: Arcutis Biotherapeutics Clinical Site 10
state: Illinois
city: Plainfield
country: United States
facility: Arcutis Biotherapeutics Clinical Site 22
state: Indiana
city: Louisville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 15
state: Kentucky
city: Metairie
country: United States
facility: Arcutis Biotherapeutics Clinical Site 52
state: Louisiana
city: Rockville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 28
state: Maryland
city: Brighton
country: United States
facility: Arcutis Biotherapeutics Clinical Site 73
state: Massachusetts
city: Clinton Township
country: United States
facility: Arcutis Biotherapeutics Clinical Site 40
state: Michigan
city: Detroit
country: United States
facility: Arcutis Biotherapeutics Clinical Site 20
state: Michigan
city: Fort Gratiot
country: United States
facility: Arcutis Biotherapeutics Clinical Site 58
state: Michigan
city: Fridley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 14
state: Minnesota
city: Las Vegas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 50
state: Nevada
city: Portsmouth
country: United States
facility: Arcutis Biotherapeutics Clinical Site 56
state: New Hampshire
city: Bronx
country: United States
facility: Arcutis Biotherapeutics Clinical Site 63
state: New York
city: New York
country: United States
facility: Arcutis Biotherapeutics Clinical Site 55
state: New York
city: High Point
country: United States
facility: Arcutis Biotherapeutics Clinical Site 23
state: North Carolina
city: Bexley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 18
state: Ohio
city: Portland
country: United States
facility: Arcutis Biotherapeutics Clinical Site 29
state: Oregon
city: Pittsburgh
country: United States
facility: Arcutis Biotherapeutics Clinical Site 27
state: Pennsylvania
city: Charleston
country: United States
facility: Arcutis Biotherapeutics Clinical Site 76
state: South Carolina
city: Arlington
country: United States
facility: Arcutis Biotherapeutics Clinical Site 13
state: Texas
city: Austin
country: United States
facility: Arcutis Biotherapeutics Clinical Site 11
state: Texas
city: College Station
country: United States
facility: Arcutis Biotherapeutics Clinical Site 41
state: Texas
city: Houston
country: United States
facility: Arcutis Biotherapeutics Clinical Site 25
state: Texas
city: Pflugerville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 26
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 54
state: Texas
city: Norfolk
country: United States
facility: Arcutis Biotherapeutics Clinical Site 17
state: Virginia
Study officials:
affiliation: Arcutis Biotherapeutics
name: David Berk, MD
role: STUDY_DIRECTOR
References: