Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

NCT ID: NCT04445987

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2022-11-19

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.

Conditions

Seborrheic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Long-term safety of ARQ-154

Open-label, Long-term Safety of ARQ-154

Group Type: EXPERIMENTAL

ARQ-154

Intervention Type: DRUG

ARQ-154 foam 0.3% applied once daily for 52 weeks

Interventions

ARQ-154

ARQ-154 foam 0.3% applied once daily for 52 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Berk, MD

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics

Locations

Arcutis Biotherapeutics Clinical Site 59

Beverly Hills, California, United States

Arcutis Biotherapeutics Clinical Site 51

Encino, California, United States

Arcutis Biotherapeutics Clinical Site 75

Fountain Valley, California, United States

Arcutis Biotherapeutics Clinical Site 19

Fremont, California, United States

Arcutis Biotherapeutics Clinical Site 62

Los Angeles, California, United States

Arcutis Biotherapeutics Clinical Site 64

San Diego, California, United States

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, United States

Arcutis Biotherapeutics Clinical Site 53

Aventura, Florida, United States

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, United States

Arcutis Biotherapeutics Clinical Site 57

Delray Beach, Florida, United States

Arcutis Biotherapeutics Clinical Site 24

Miami, Florida, United States

Arcutis Biotherapeutics Clinical Site 65

Sanford, Florida, United States

Arcutis Biotherapeutics Clinical Site 12

Tampa, Florida, United States

Arcutis Biotherapeutics Clinical Site 10

Rolling Meadows, Illinois, United States

Arcutis Biotherapeutics Clinical Site 22

Plainfield, Indiana, United States

Arcutis Biotherapeutics Clinical Site 15

Louisville, Kentucky, United States

Arcutis Biotherapeutics Clinical Site 52

Metairie, Louisiana, United States

Arcutis Biotherapeutics Clinical Site 28

Rockville, Maryland, United States

Arcutis Biotherapeutics Clinical Site 73

Brighton, Massachusetts, United States

Arcutis Biotherapeutics Clinical Site 40

Clinton Township, Michigan, United States

Arcutis Biotherapeutics Clinical Site 20

Detroit, Michigan, United States

Arcutis Biotherapeutics Clinical Site 58

Fort Gratiot, Michigan, United States

Arcutis Biotherapeutics Clinical Site 14

Fridley, Minnesota, United States

Arcutis Biotherapeutics Clinical Site 50

Las Vegas, Nevada, United States

Arcutis Biotherapeutics Clinical Site 56

Portsmouth, New Hampshire, United States

Arcutis Biotherapeutics Clinical Site 55

New York, New York, United States

Arcutis Biotherapeutics Clinical Site 63

The Bronx, New York, United States

Arcutis Biotherapeutics Clinical Site 23

High Point, North Carolina, United States

Arcutis Biotherapeutics Clinical Site 18

Bexley, Ohio, United States

Arcutis Biotherapeutics Clinical Site 29

Portland, Oregon, United States

Arcutis Biotherapeutics Clinical Site 27

Pittsburgh, Pennsylvania, United States

Arcutis Biotherapeutics Clinical Site 76

Charleston, South Carolina, United States

Arcutis Biotherapeutics Clinical Site 13

Arlington, Texas, United States

Arcutis Biotherapeutics Clinical Site 11

Austin, Texas, United States

Arcutis Biotherapeutics Clinical Site 41

College Station, Texas, United States

Arcutis Biotherapeutics Clinical Site 25

Houston, Texas, United States

Arcutis Biotherapeutics Clinical Site 26

Pflugerville, Texas, United States

Arcutis Biotherapeutics Clinical Site 54

San Antonio, Texas, United States

Arcutis Biotherapeutics Clinical Site 17

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARQ-154-214

Identifier Type: -

Identifier Source: org_study_id