Status:
COMPLETED
Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT03764475
Start Date
December 18 2018
End Date
October 8 2020
Last Update
September 2 2022
Active Locations (30)
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1
Arcutis Clinical Site 35
Beverly Hills, California, United States, 90212
2
Arcutis Clinical Site 29
Northridge, California, United States, 91324
3
Arcutis Clinical Site 28
San Diego, California, United States, 92123
4
Arcutis Clinical Site 27
Santa Monica, California, United States, 90403