Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
NCT ID: NCT04378569
Last Updated: 2024-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
230 participants
INTERVENTIONAL
2020-04-20
2021-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Cohort 1 (Phase 1) is a multiple dose cohort in which subjects with chronic hand eczema will be assigned to ARQ-252 cream 0.3% QD x 2 weeks to be applied to both hands (approximately 4% of BSA).
* Cohort 2 (Phase 2b) is a parallel group, double blind, vehicle-controlled cohort in which subjects with chronic hand eczema will be randomized to ARQ-252 cream 0.3% QD, ARQ-252 cream 0.3% BID, ARQ-252 cream 0.1% QD, vehicle cream BID or vehicle cream QD x 12 weeks to be applied to both hands (approximately 4% of BSA).
TREATMENT
TRIPLE
Study Groups
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ARQ-252 cream 0.3% QD (once daily)
Active Comparator
ARQ-252 cream 0.3%
ARQ-252 cream 0.3%
ARQ-252 cream 0.3% BID (twice daily)
Active Comparator
ARQ-252 cream 0.3%
ARQ-252 cream 0.3%
ARQ-252 cream 0.1% QD (once daily)
Active Comparator
ARQ-252 cream 0.1%
ARQ-252 cream 0.1%
Vehicle cream BID (twice daily)
Placebo Comparator
ARQ-252 Vehicle Cream
ARQ-252 Vehicle Cream
Vehicle cream QD (once daily)
Placebo Comparator
ARQ-252 Vehicle Cream
ARQ-252 Vehicle Cream
Interventions
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ARQ-252 cream 0.3%
ARQ-252 cream 0.3%
ARQ-252 cream 0.1%
ARQ-252 cream 0.1%
ARQ-252 Vehicle Cream
ARQ-252 Vehicle Cream
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Arcutis Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Berk, MD
Role: STUDY_DIRECTOR
Arcutis Biotherapeutics, Inc.
Locations
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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
Arcutis Clinical Site 213
Metairie, Louisiana, United States
Arcutis Clinical Site 125
Rockville, Maryland, United States
Arcutis Clinical Site 212
Detroit, Michigan, United States
Arcutis Clinical Site 216
New Brighton, Minnesota, United States
Arcutis Clinical Site 171
New York, New York, United States
Arcutis Clinical Site 115
High Point, North Carolina, United States
Arcutis Clinical Site 173
Portland, Oregon, United States
Arcutis Clinical Site 135
Pittsburgh, Pennsylvania, United States
Arcutis Clinical Site 162
Austin, Texas, United States
Arcutis Clinical Site 104
College Station, Texas, United States
Arcutis Clinical Site 164
Houston, Texas, United States
Arcutis Clinical Site 163
Pflugerville, Texas, United States
Arcutis Clinical Site 161
San Antonio, Texas, United States
Arcutis Clinical Site 110
San Antonio, Texas, United States
Arcutis Clinical Site 169
Norfolk, Virginia, United States
Arcutis Clinical Site 306
Westmead, New South Wales, Australia
Arcutis Clinical Site 303
East Melbourne, Victoria, Australia
Arcutis Clinical Site 207
Surrey, British Columbia, Canada
Arcutis Clinical Site 205
Ajax, Ontario, Canada
Arcutis Clinical Site 218
Barrie, Ontario, Canada
Arcutis Clinical Site 103
London, Ontario, Canada
Arcutis Clinical Site 133
Mississauga, Ontario, Canada
Arcutis Clinical Site 165
Oakville, Ontario, Canada
Arcutis Clinical Site 109
Peterborough, Ontario, Canada
Arcutis Clinical Site 241
Richmond Hill, Ontario, Canada
Arcutis Clinical Site 106
Waterloo, Ontario, Canada
Arcutis Clinical Site 242
Montreal, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARQ-252-205
Identifier Type: -
Identifier Source: org_study_id
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