Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Arcutis Biotherapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws. 2.Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.) 3.Subjects with atopic dermatitis who met eligibility criteria for and successfully completed ARQ-151-311 or ARQ-151-312 or ARQ-151-315 through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study. 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 a highly effective or barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active. 5.Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). 6.Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Are the trial subjects under 18? yes Number of subjects for this age range: 1324 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: 1.Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in studies ARQ-151-311 or ARQ-151-312 or ARQ-151-315. 2.Subjects that use any Excluded Medications and Treatments (see Table 2). 3.Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements (e.g., molluscum contagiosum). 4.Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome. 5.Known allergies to excipients in ARQ-151 cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphate and ceteth-10 phosphate). 6.Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period. 7.Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin during the study period. 8.Known or suspected: a.Severe renal insufficiency (defined as calculated creatinine clearance < 30mL/min) Refer to the creatinine levels from the following visits: •ARQ-151-311/ARQ-151-312 studies: Screening Visit for subjects ages 6-11 and Baseline/Day 1 for subjects =12 years old (for subjects 12-18 years old, if screening lab tests were collected within 3 weeks of Baseline/Day 1, screening results will be used) •ARQ-151-315 study: Screening Visit b.Moderate to severe hepatic disorders (Child-Pugh B or C) c.History of severe depression, suicidal ideation or behavior 9.Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 10.Subjects with any known serious medical condition (e.g., uncontrolled hypo- or hyper-thyroidism) or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. 11.Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication. 12.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. 13.Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator’s opinion, makes them unsuitable for clinical study participation. 14.Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151) living in the same house.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety in a multicenter, open-label, single-arm study in subjects with atopic dermatitis treated with ARQ-151 cream 0.15% QD (subjects = 6 years of age) or ARQ-151 cream 0.05% QD (subjects 2 to 5 years of age) after completing one of three Phase 3 studies (ARQ-151-311, ARQ-151-312, or ARQ-151-315).;Secondary Objective: Not applicable;Primary end point(s): •Adverse Events (AEs) •Serious Adverse Events (SAEs) ;Timepoint(s) of evaluation of this end point: Day 1, Week 4, Week 12, Week 18, Week 24, Week 30, Week 36, Week 44, Week 52/ET | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) value 0 or 1 at each assessment •vIGA-AD success (defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline) •WI-NRS score over time •EASI score over time ;Timepoint(s) of evaluation of this end point: Day 1, Week 4, Week 12, Week 24, Week 36, Week 52/ET | — |
Countries
Canada, Dominican Republic, Poland, United States
Contacts
Public ContactThe Information at Arcutis
Arcutis Biotherapeutics, Inc.
Outcome results
None listed