A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects with Atopic Dermatitis

Phase 1

• Conditions: Atopic Dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-006903-14-PL
• Lead Sponsor: Arcutis Biotherapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-27
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

1.Informed consent of parent(s) or legal guardian as required by local laws.
2.Males and females, ages 2 to 5 years old (inclusive) at time of signing the Informed Consent (Screening) and at Baseline/Day 1.
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 [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 6 weeks as determined by the Investigator through subject interview. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
5.EASI Score =5 at Baseline/Day 1. 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/Day 1. The vIGA-AD is evaluated for the entire body except the scalp, palms, and soles.
7.Has AD involvement of =3% BSA at Baseline/Day 1 (excluding the scalp, palms, soles).
8.In good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, and hematology values.
9.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: 650
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Tabel 1).
3.Has unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
4.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 and during the study.
5.Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
6.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.
7.Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.
8.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).
9.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 the baseline visit and during the study period.
10.Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin and carbamazepine for 2 weeks prior to the baseline visit and during the study period.
11.Subjects who have received oral roflumilast (Daxas®, Daliresp®) within the past 4 weeks prior to Baseline/Day 1.
12.Known or suspected:
a.Severe renal insufficiency
- Severe renal insufficiency is defined as calculated creatinine clearance <30 mL/min
b.Moderate to severe hepatic disorders (Child-Pugh B or C)
13.Previous treatment with ARQ-151.
14.Subjects currently undergoing allergy testing (e.g., food allergy testing or skin prick testing), patch testing, food challenges, or allergy desensitization, or plan to do so during the study.
15.Subjects with any serious known medical condition or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
16.Subjects with a history of a major surgery within 4 weeks prior to Baseline/Day 1 or subjects who have a major surgery planned during the study.
17.Any history of cancer.
18.Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who display any condition which in the Investigator’s opinion, makes them unsuitable for clinical study participation.
19.Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family m

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified