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

A Phase 1/2b, Multiple Dose and 12-Week, Parallel Group, Double Blind, Dose Ranging, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.1% and ARQ-252 Cream 0.3% in Subjects With Chronic Hand Eczema

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

Study Overview

• Status: Completed
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Drug: ARQ-252 cream 0.3%; Drug: ARQ-252 cream 0.1%; Drug: ARQ-252 Vehicle Cream

Detailed Description

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
• Enrollment (Actual): 230
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Arcutis Clinical Site 306
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Arcutis Clinical Site 303
• Canada
  • Montreal, Canada
    • Arcutis Clinical Site 242
  • British Columbia
    • Surrey, British Columbia, Canada
      • Arcutis Clinical Site 207
  • Ontario
    • Ajax, Ontario, Canada
      • Arcutis Clinical Site 205
    • Barrie, Ontario, Canada
      • Arcutis Clinical Site 218
    • London, Ontario, Canada
      • Arcutis Clinical Site 103
    • Mississauga, Ontario, Canada
      • Arcutis Clinical Site 133
    • Oakville, Ontario, Canada
      • Arcutis Clinical Site 165
    • Peterborough, Ontario, Canada
      • Arcutis Clinical Site 109
    • Richmond Hill, Ontario, Canada
      • Arcutis Clinical Site 241
    • Waterloo, Ontario, Canada
      • Arcutis Clinical Site 106
• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Arcutis Clinical Site 239
    • Encino, California, United States, 91436
      • Arcutis Clinical Site 225
    • Fremont, California, United States, 94538
      • Arcutis Clinical Site 112
    • Irvine, California, United States, 92797
      • Arcutis Clinical Site 120
    • Santa Monica, California, United States, 90404
      • Arcutis Clinical Site 208
  • Florida
    • Aventura, Florida, United States, 33180
      • Arcutis Clinical Site 174
    • Coral Gables, Florida, United States, 33134
      • Arcutis Clinical Site 167
    • Sanford, Florida, United States, 32771
      • Arcutis Clinical Site 104
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Arcutis Clinical Site 214
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Arcutis Clinical Site 217
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Arcutis Clinical Site 213
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Arcutis Clinical Site 125
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Arcutis Clinical Site 212
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Arcutis Clinical Site 216
  • New York
    • New York, New York, United States, 10029
      • Arcutis Clinical Site 171
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Arcutis Clinical Site 115
  • Oregon
    • Portland, Oregon, United States, 97210
      • Arcutis Clinical Site 173
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Arcutis Clinical Site 135
  • Texas
    • Austin, Texas, United States, 78759
      • Arcutis Clinical Site 162
    • College Station, Texas, United States, 77845
      • Arcutis Clinical Site 104
    • Houston, Texas, United States, 77056
      • Arcutis Clinical Site 164
    • Pflugerville, Texas, United States, 78660
      • Arcutis Clinical Site 163
    • San Antonio, Texas, United States, 78213
      • Arcutis Clinical Site 161
    • San Antonio, Texas, United States, 78218
      • Arcutis Clinical Site 110
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Arcutis Clinical Site 169

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARQ-252 cream 0.3% QD (once daily); Active Comparator	Drug: ARQ-252 cream 0.3%; ARQ-252 cream 0.3%
Active Comparator: ARQ-252 cream 0.3% BID (twice daily); Active Comparator	Drug: ARQ-252 cream 0.3%; ARQ-252 cream 0.3%
Active Comparator: ARQ-252 cream 0.1% QD (once daily); Active Comparator	Drug: ARQ-252 cream 0.1%; ARQ-252 cream 0.1%
Placebo Comparator: Vehicle cream BID (twice daily); Placebo Comparator	Drug: ARQ-252 Vehicle Cream; ARQ-252 Vehicle Cream
Placebo Comparator: Vehicle cream QD (once daily); Placebo Comparator	Drug: ARQ-252 Vehicle Cream; ARQ-252 Vehicle Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Up to 3 weeks
Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12	The IGA is 5-point scale assessing the severity of hand eczema; scores range 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' at Week 12 is presented.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Weeks 2, 4, 8 and 12
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'	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 is presented.	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.	Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score	The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean change from baseline in WI-NRS is reported.	Weeks 2, 4, 8, and 12
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score	The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours (higher scores indicate higher itch severity). The mean change from baseline in WI-NRS is reported. The number of participants with a baseline WI-NRS score of ≥4 who achieved a ≥4-point reduction is reported.	Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score	The HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) on 5 areas of the hand (fingertips, fingers [except tips], palm, back of hand, wrists) by use of a standard scale. Each subscale is scored from 0 to 60; the total HECSI score ranges from 0 to 360 with higher scores indicating greater symptom severity. The mean change from baseline in HECSI is reported.	Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score	The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The mean change from baseline NRS Pain score is reported.	Weeks 2, 4, 8, and 12
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score	The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The number of participants with ≥4-point reduction from baseline NRS Pain score is reported.	Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit	The QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. The scoring ranges from 0 ('no eczema') to 117 ('most severe eczema').	Weeks 2, 4, 8, 12, 13
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease	The percentage of total body surface area (BSA) affected by chronic hand eczema (CHE) is a measure of the area of the subject's hands that is affected by CHE lesions, expressed as a percentage of total BSA. Based on the subject's hand method, the BSA of 1 side of 1 hand is assumed to be 1% of total BSA. The surface area of lesions on both sides of both hands are added to calculate the total BSA affected by CHE. The total BSA affected by CHE ranges from 0% (no CHE lesions) to 4% (the entire front and back sides of both hands are affected by CHE lesions).	Weeks 2, 4, 8, 12

Collaborators and Investigators

• Sponsor: Arcutis Biotherapeutics, Inc.
• Investigators: Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: ARQ-252-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No