Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

NCT ID: NCT03764475

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-18
• Study Completion Date: 2020-10-08

Brief Summary

This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Detailed Description

Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201 (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in ARQ-151-201.

Conditions

Plaque Psoriasis

Study Design

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

Study Groups

Long-term Safety of Roflumilast

Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 52 weeks

Group Type: OTHER

Roflumilast

Intervention Type: DRUG

Roflumilast cream 0.3% for topical application

Interventions

Roflumilast

Roflumilast cream 0.3% for topical application

Intervention Type: DRUG

Other Intervention Names

ARQ-151

Eligibility Criteria

Inclusion Criteria

1. Participants legally competent to sign and give informed consent

2. Males and females ages 18 years and older

3. Subjects with chronic plaque psoriasis who met eligibility criteria for ARQ-151-201, successfully completed ARQ-151-201 through Week 12, and are able to enroll into this long-term safety study on the Week 12 visit of the previous study (ARQ-151-201).

4. 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 highly effective contraception throughout the trial. Highly effective forms of contraception include: oral/implant/injectable/transdermal contraceptives, intrauterine device, or partner's vasectomy. If barrier methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms of conception are required. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and a backup method has been identified if the subject becomes sexually active.

5. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).

Exclusion Criteria

1. Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in Study ARQ-151-201.

2. Subjects that use any Excluded Medications and Treatments

3. Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular psoriasis.

4. 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.

5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin during the study period.

6. Known or suspected:

• severe renal insufficiency or severe hepatic disorders
• hypersensitivity to component(s) of the investigational products
• history of severe depression, suicidal ideation

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 drug abuse within 6 months of initiation of study medication.

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.

• Minimum Eligible Age: 18 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 Clinical Site 35

Beverly Hills, California, United States

Arcutis Clinical Site 29

Northridge, California, United States

Arcutis Clinical Site 28

San Diego, California, United States

Arcutis Clinical Site 27

Santa Monica, California, United States

Arcutis Clinical Site 12

Miami, Florida, United States

Arcutis Clinical Site 16

Sanford, Florida, United States

Arcutis Clinical Site 21

Louisville, Kentucky, United States

Arcutis Clinical Site 34

Clinton Township, Michigan, United States

Arcutis Clinical Site 33

Detroit, Michigan, United States

Arcutis Clinical Site 20

Fridley, Minnesota, United States

Arcutis Clinical Site 22

New York, New York, United States

Arcutis Clinical Site 14

High Point, North Carolina, United States

Arcutis Clinical Site 39

Bexley, Ohio, United States

Arcutis Clinical Site 15

Pittsburgh, Pennsylvania, United States

Arcutis Clinical Site 19

College Station, Texas, United States

Arcutis Clinical Site 37

Houston, Texas, United States

Arcutis Clinical Site 13

Houston, Texas, United States

Arcutis Clinical Site 23

San Antonio, Texas, United States

Arcutis Clinical Site 24

Webster, Texas, United States

Arcutis Clinical Site 31

Norfolk, Virginia, United States

Arcutis Clinical Site 18

Surrey, British Columbia, Canada

Arcutis Clinical Site 11

Surrey, British Columbia, Canada

Arcutis Clinical Site 38

Winnipeg, Manitoba, Canada

Arcutis Clinical Site 10

Ajax, Ontario, Canada

Arcutis Clinical Site 25

London, Ontario, Canada

Arcutis Clinical Site 26

Markham, Ontario, Canada

Arcutis Clinical Site 32

Oakville, Ontario, Canada

Arcutis Clinical Site 17

Peterborough, Ontario, Canada

Arcutis Clinical Site 30

Waterloo, Ontario, Canada

Arcutis Clinical Site 36

Windsor, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARQ-151-202

Identifier Type: -

Identifier Source: org_study_id