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

Phase 1

Completed

Conditions: Chronic Hand Eczema

Interventions: Drug: ARQ-252 Vehicle Cream
Drug: ARQ-252 cream 0.3%
Drug: ARQ-252 cream 0.1%

Registration Number: NCT04378569

Lead Sponsor: Arcutis Biotherapeutics, Inc.

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle cream BID (twice daily)	ARQ-252 Vehicle Cream	Placebo Comparator
ARQ-252 cream 0.3% BID (twice daily)	ARQ-252 cream 0.3%	Active Comparator
ARQ-252 cream 0.3% QD (once daily)	ARQ-252 cream 0.3%	Active Comparator
ARQ-252 cream 0.1% QD (once daily)	ARQ-252 cream 0.1%	Active Comparator
Vehicle cream QD (once daily)	ARQ-252 Vehicle Cream	Placebo Comparator

Primary Outcome Measures

Name	Time	Method
Cohort 1: Number of Participants With an Application Site Reaction	Up to 3 weeks	The number of Cohort 1 participants with AEs coded as application site events is reported.
Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)	Up to 3 weeks	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.
Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters	Up to 3 weeks	The number of Cohort 1 participants with a significant change in hematology is reported.
Cohort 1: Number of Participants With ≥1 Adverse Event (AE)	Up to 3 weeks	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.
Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12	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.
Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters	Up to 3 weeks	The number of Cohort 1 participants with a significant change in chemistry is reported.

Secondary Outcome Measures

Name	Time	Method
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score	Weeks 2, 4, 8, and 12	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.
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score	Weeks 2, 4, 8, and 12	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.
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline	Weeks 2, 4, 8 and 12	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.
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline	Weeks 2, 4, 8 and 12	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.
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score	Weeks 2, 4, 8, and 12	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.
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score	Weeks 2, 4, 8, and 12	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.
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit	Weeks 2, 4, 8, 12, 13	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').
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'	Weeks 2, 4, and 8	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.
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score	Weeks 2, 4, 8, and 12	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.
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score	Weeks 2, 4, 8, and 12	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.
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease	Weeks 2, 4, 8, 12	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).

Trial Locations

Locations (36): Arcutis Clinical Site 103
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London, Ontario, Canada
Arcutis Clinical Site 241
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Richmond Hill, Ontario, Canada
Arcutis Clinical Site 109
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Peterborough, Ontario, Canada
Arcutis Clinical Site 120
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Irvine, California, United States
Arcutis Clinical Site 135
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Pittsburgh, Pennsylvania, United States
Arcutis Clinical Site 216
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New Brighton, Minnesota, United States
Arcutis Clinical Site 214
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Indianapolis, Indiana, United States
Arcutis Clinical Site 212
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Detroit, Michigan, United States
Arcutis Clinical Site 110
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San Antonio, Texas, United States
Arcutis Clinical Site 239
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Beverly Hills, California, United States
Arcutis Clinical Site 225
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Encino, California, United States
Arcutis Clinical Site 112
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Fremont, California, United States
Arcutis Clinical Site 104
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College Station, Texas, United States
Arcutis Clinical Site 167
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Coral Gables, Florida, United States
Arcutis Clinical Site 174
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Aventura, Florida, United States
Arcutis Clinical Site 213
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Metairie, Louisiana, United States
Arcutis Clinical Site 171
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New York, New York, United States
Arcutis Clinical Site 125
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Rockville, Maryland, United States
Arcutis Clinical Site 164
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Houston, Texas, United States
Arcutis Clinical Site 115
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High Point, North Carolina, United States
Arcutis Clinical Site 163
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Pflugerville, Texas, United States
Arcutis Clinical Site 173
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Portland, Oregon, United States
Arcutis Clinical Site 306
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Westmead, New South Wales, Australia
Arcutis Clinical Site 161
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San Antonio, Texas, United States
Arcutis Clinical Site 169
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Norfolk, Virginia, United States
Arcutis Clinical Site 303
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East Melbourne, Victoria, Australia
Arcutis Clinical Site 207
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Surrey, British Columbia, Canada
Arcutis Clinical Site 205
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Ajax, Ontario, Canada
Arcutis Clinical Site 218
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Barrie, Ontario, Canada
Arcutis Clinical Site 133
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Mississauga, Ontario, Canada
Arcutis Clinical Site 165
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Oakville, Ontario, Canada
Arcutis Clinical Site 242
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Montreal, Canada
Arcutis Clinical Site 106
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Waterloo, Ontario, Canada
Arcutis Clinical Site 208
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Santa Monica, California, United States
Arcutis Clinical Site 162
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Austin, Texas, United States
Arcutis Clinical Site 217
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Louisville, Kentucky, United States