Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema

Arcutis Biotherapeutics, Inc.230 enrolled

Overview

This study will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema

This is a Phase 1/2b multiple dose, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

230

Conditions

Chronic Hand Eczema

Interventions

ARQ-252 cream 0.3%DRUG

ARQ-252 cream 0.3%

ARQ-252 cream 0.1%DRUG

ARQ-252 cream 0.1%

ARQ-252 Vehicle CreamDRUG

ARQ-252 Vehicle Cream

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Participants legally competent to sign and give informed consent. * Males and females 18 years of age and older (inclusive) at the time of consent. * Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more than 3 months, or returned twice or more within the last 12 months. Generally stable disease for 6 weeks. * Chronic hand eczema involving at least 0.3% body surface area total (i.e., approximately a third of one handprint) lesions on both hands added together * Female subjects of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. For FOCBP involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method for at least 4 weeks prior to Day 1. Additionally, from Day 1 until at least 4 weeks after the last investigational product administration, these subjects must agree to use at least 1 highly effective contraceptive method in addition to 1 barrier method according to the Contraception Requirements Section of the protocol. * Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. * Males, if engaging in sexual intercourse with a female who is pregnant or a female of childbearing potential, must agree to use a condom every time during the study and every and every time subsequently until 4 weeks after the last dose of investigational product. * Subjects in good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis. Exclusion Criteria * Concurrent skin diseases on the hands which, in the opinion of the Investigator, could confound the study (e.g., tinnea manuum). * Subjects with any presence or history of psoriasis. * History of a positive patch test with continued exposure to allergen. Subjects must have undergone diagnostic patch testing within 3 years prior to Baseline (Visit 2). * Subjects who cannot discontinue systemic and/or topical therapies for the treatment of chronic hand eczema prior to Baseline and during the study * Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Baseline * Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of investigational product. * Subjects with any serious medical condition or clinically significant laboratory, ECG, vital signs or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.

Locations (37)

Outcomes

Primary Outcomes

Cohort 1: Number of Participants With ≥1 Adverse Event (AE)

The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.

Time frame: Up to 3 weeks

Cohort 1: Number of Participants With an Application Site Reaction

The number of Cohort 1 participants with AEs coded as application site events is reported.

Time frame: Up to 3 weeks

Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)

The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health.

Time frame: Up to 3 weeks

Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters

The number of Cohort 1 participants with a significant change in hematology is reported.

Time frame: Up to 3 weeks

Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters

The number of Cohort 1 participants with a significant change in chemistry is reported.

Time frame: Up to 3 weeks

Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Arcutis Clinical Site 239

Beverly Hills, California, United States

Arcutis Clinical Site 225

Encino, California, United States

Arcutis Clinical Site 112

Fremont, California, United States

Arcutis Clinical Site 120

Irvine, California, United States

Arcutis Clinical Site 208

Santa Monica, California, United States

Arcutis Clinical Site 174

Aventura, Florida, United States

Arcutis Clinical Site 167

Coral Gables, Florida, United States

Arcutis Clinical Site 104

Sanford, Florida, United States

Arcutis Clinical Site 214

Indianapolis, Indiana, United States

Arcutis Clinical Site 217

Louisville, Kentucky, United States

...and 27 more locations

Secondary Outcomes

Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline

The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' plus ≥2-point improvement (ie, decrease) from Baseline is presented.

Time frame: Weeks 2, 4, 8 and 12

Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline

The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline in IGA score is presented.

Time frame: Weeks 2, 4, 8 and 12

Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'

Time frame: Weeks 2, 4, and 8

Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score

The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The mean change from baseline in IGA score is presented, with lower scores indicating a reduction in symptom severity.