Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
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 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada. 3.Diagnosed with mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka (1980) prior to or at the screening visit. Subjects must have at least 3 of the 4 basic features per Hanifin and Rajka (1. Pruritus; 2. Typical morphology and distribution [flexural lichenification in adults and facial and extensor eruptions in infants and children]; 3. Chronic or chronically relapsing dermatitis; or 4. Personal or family history of atopy), in addition to 3 or more minor criteria. 4.History of AD for at least 3 months in subjects 6-17 years of age or 6 months in subjects =18 years of age, as determined by the Investigator using information from the subject’s medical chart, from the subject’s physician, or through subject/parent/caregiver interview. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening. 5.EASI Score =5 at Baseline. EASI is evaluated for the entire body except the scalp, palms, and soles. 6.vIGA-AD score of ‘Mild’ (‘2’) or ‘Moderate’ (‘3’) at Baseline. The vIGA-AD is evaluated for the entire body except the scalp, palms, and soles. 7.Has AD involvement of =3% BSA (excluding the scalp, palms, soles) at Baseline. 8.Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. 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. 9.Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status should be confirmed with FSH testing) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). 10.In good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis. 11.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: 325 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 276 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 49
Exclusion criteria
Exclusion criteria: 1.Subjects with any serious medical condition or clinically significant laboratory, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator 2.Liver function tests excursions that exceed: •AST or ALT > 2X ULN •Total bilirubin: •> 1.5 x ULN or •> ULN and = 1.5 x ULN AND direct bilirubin is > 35% of total bilirubin •ALP = 2x ULN 3.Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 2). 4.Has unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms. 5.Subjects who have significant active systemic or localized infection (e.g., molluscum contagiosum), including known actively infected AD, or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 14 days prior to Baseline/Day 1. 6.Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study. 7.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. 8.Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome. 9.Known allergies to excipients in ARQ-151 cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate). 10.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 for 2 weeks prior to Baseline/Day 1 and during the study period. 11.Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for 2 weeks prior to Baseline/ Day 1 and during the study period. ? 12.Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/ Day 1. 13.Known or suspected: •Severe renal insufficiency - Severe renal insufficiency is defined as calculated creatinine clearance <30 mL/min. •Moderate to severe hepatic disorders (Child-Pugh B or C) 14.History of severe depression, suicidal ideation or behavior, Baseline/Screening C-SSRS (for adolescents and adults 12 years old and older) indicative of suicidal ideation or behavior, whether lifetime or recent/current. 15.Subjects with a PHQ-8 (adults) or modified PHQ-A (adolescents, 12-17 years old inclusive) score =10 at Screening or Baseline/Day 1 visits. 16.Subjects (6 to 11 years old, inclusive) with a CDI-2 (parent report) raw score =17 for females and =18 for males at Screening or Baseline/Day 1 visits. 17.Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 18.Previous treatment with ARQ-151. 19.Subjects currently undergoing allergy testing (e.g., food allergy testing or skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of ARQ-151 cream 0.15% vs vehicle administered QD x 4 weeks to individuals with atopic dermatitis.;Secondary Objective: Not applicable;Primary end point(s): Primary Efficacy Endpoint: IGA Success, defined as a vIGA-AD score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement from Baseline at Week 4;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: •In subjects with a vIGA-AD score of ‘Moderate’ at randomization, vIGA-AD Success at Week 4 •In subjects with Baseline WI-NRS 4, achievement of at least a 4-point reduction on the WI-NRS at Week 4 •In subjects with Baseline WI-NRS 4, achievement of at least a 4-point reduction on the WI-NRS at Week 2 •In subjects with baseline WI-NRS 4, achievement of at least a 4-point reduction on the WI-NRS at Week 1 •Achievement of at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 •vIGA-AD of ‘clear’ or ‘almost clear’ at Week 4 •vIGA-AD Success at Week 2 •vIIA-AD Success at Week 1 •vIGA-AD of ‘clear’ or ‘almost clear’ at Week 2 •vIGA-AD of ‘clear’ or ‘almost clear’ at Week 1 Pharmacokinetic endpoints include concentrations of roflumilast and its N-oxide metabolite.;Timepoint(s) of evaluation of this end point: Week 1, Week 2, Week 4 | — |
Countries
Canada, Dominican Republic, Poland, United States
Contacts
Public ContactThe Information at Arcutis
Arcutis Biotherapeutics, Inc.
Outcome results
None listed