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

NCT03764475 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ARQ-151-202
• Study Type: interventional
• Target: 332
• Locations: 2 countries
• Sites: 30

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)

  An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs \[TEAEs\]) in ARQ-151-202 are presented.

  Up to 52 weeks

• Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)

  An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

  Up to 52 weeks

Secondary Outcomes (4)

• Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'

  Weeks 12, 24, 36, and 52

• Duration of Response in Participants Achieving 'Clear' IGA Score

  Up to 52 weeks

• Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear'

  Weeks 12, 24, 36, and 52

• Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75)

  Baseline and Weeks 12, 24, 36, and 52

Study Arms (1)

Long-term Safety of Roflumilast

OTHER

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

Drug: Roflumilast

Interventions

Roflumilast DRUG

Roflumilast cream 0.3% for topical application

Also known as: ARQ-151

Long-term Safety of Roflumilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants legally competent to sign and give informed consent
• Males and females ages 18 years and older
• 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).
• 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.
• 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).

You may not qualify if:

• 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.
• Subjects that use any Excluded Medications and Treatments
• Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular psoriasis.
• 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.
• 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.
• Known or suspected:
• severe renal insufficiency or severe hepatic disorders
• hypersensitivity to component(s) of the investigational products
• history of severe depression, suicidal ideation
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• 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.
• Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
• 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.
• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (30)

Arcutis Clinical Site 35

Beverly Hills, California, 90212, United States

Location

Arcutis Clinical Site 29

Northridge, California, 91324, United States

Location

Arcutis Clinical Site 28

San Diego, California, 92123, United States

Location

Arcutis Clinical Site 27

Santa Monica, California, 90403, United States

Location

Arcutis Clinical Site 12

Miami, Florida, 33144, United States

Location

Arcutis Clinical Site 16

Sanford, Florida, 32771, United States

Location

Arcutis Clinical Site 21

Louisville, Kentucky, 40217, United States

Location

Arcutis Clinical Site 34

Clinton Township, Michigan, 48038, United States

Location

Arcutis Clinical Site 33

Detroit, Michigan, 48202, United States

Location

Arcutis Clinical Site 20

Fridley, Minnesota, 55432, United States

Location

Arcutis Clinical Site 22

New York, New York, 10029, United States

Location

Arcutis Clinical Site 14

High Point, North Carolina, 27262, United States

Location

Arcutis Clinical Site 39

Bexley, Ohio, 43209, United States

Location

Arcutis Clinical Site 15

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Clinical Site 19

College Station, Texas, 77845, United States

Location

Arcutis Clinical Site 37

Houston, Texas, 77004, United States

Location

Arcutis Clinical Site 13

Houston, Texas, 77056, United States

Location

Arcutis Clinical Site 23

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 24

Webster, Texas, 77598, United States

Location

Arcutis Clinical Site 31

Norfolk, Virginia, 23502, United States

Location

Arcutis Clinical Site 18

Surrey, British Columbia, V3R 6A7, Canada

Location

Arcutis Clinical Site 11

Surrey, British Columbia, V3V 0C6, Canada

Location

Arcutis Clinical Site 38

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Arcutis Clinical Site 10

Ajax, Ontario, L1S 7K8, Canada

Location

Arcutis Clinical Site 25

London, Ontario, N6H 5L5, Canada

Location

Arcutis Clinical Site 26

Markham, Ontario, L3P 1X2, Canada

Location

Arcutis Clinical Site 32

Oakville, Ontario, L6J 7W5, Canada

Location

Arcutis Clinical Site 17

Peterborough, Ontario, K9J 5K2, Canada

Location

Arcutis Clinical Site 30

Waterloo, Ontario, N2J 1C4, Canada

Location

Arcutis Clinical Site 36

Windsor, Ontario, N8W 1E6, Canada

Location

MeSH Terms

Interventions

Roflumilast

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Note: Subjects that consent to enter this open-label safety study have previously completed a companion study (ARQ-151-201 Phase 2 randomized controlled trial)

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: December 18, 2018
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: September 2, 2022
• Results First Posted: August 18, 2022

Record last verified: 2022-08

Locations

CA (10); US (20)