Clinical trial NCT04378569: Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hand Eczema
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-07
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 cohorts of subjects.

* 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).
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort 1: Number of Participants With ≥1 Adverse Event (AE)
timeFrame: Up to 3 weeks
measure: Cohort 1: Number of Participants With an Application Site Reaction
timeFrame: Up to 3 weeks
measure: Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)
timeFrame: Up to 3 weeks
measure: Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
timeFrame: Up to 3 weeks
measure: Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
timeFrame: Up to 3 weeks
measure: Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
timeFrame: Weeks 2, 4, 8 and 12
measure: Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
timeFrame: Weeks 2, 4, 8 and 12
measure: Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
timeFrame: Weeks 2, 4, and 8
measure: Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
timeFrame: Weeks 2, 4, 8, and 12
measure: Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
timeFrame: Weeks 2, 4, 8, and 12
measure: Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
timeFrame: Weeks 2, 4, 8, and 12
measure: Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
timeFrame: Weeks 2, 4, 8, and 12
measure: Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
timeFrame: Weeks 2, 4, 8, and 12
measure: Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
timeFrame: Weeks 2, 4, 8, and 12
measure: Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
timeFrame: Weeks 2, 4, 8, 12, 13
measure: Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
timeFrame: Weeks 2, 4, 8, 12
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Arcutis Clinical Site 239
state: California
city: Encino
country: United States
facility: Arcutis Clinical Site 225
state: California
city: Fremont
country: United States
facility: Arcutis Clinical Site 112
state: California
city: Irvine
country: United States
facility: Arcutis Clinical Site 120
state: California
city: Santa Monica
country: United States
facility: Arcutis Clinical Site 208
state: California
city: Aventura
country: United States
facility: Arcutis Clinical Site 174
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 167
state: Florida
city: Sanford
country: United States
facility: Arcutis Clinical Site 104
state: Florida
city: Indianapolis
country: United States
facility: Arcutis Clinical Site 214
state: Indiana
city: Louisville
country: United States
facility: Arcutis Clinical Site 217
state: Kentucky
city: Metairie
country: United States
facility: Arcutis Clinical Site 213
state: Louisiana
city: Rockville
country: United States
facility: Arcutis Clinical Site 125
state: Maryland
city: Detroit
country: United States
facility: Arcutis Clinical Site 212
state: Michigan
city: New Brighton
country: United States
facility: Arcutis Clinical Site 216
state: Minnesota
city: New York
country: United States
facility: Arcutis Clinical Site 171
state: New York
city: High Point
country: United States
facility: Arcutis Clinical Site 115
state: North Carolina
city: Portland
country: United States
facility: Arcutis Clinical Site 173
state: Oregon
city: Pittsburgh
country: United States
facility: Arcutis Clinical Site 135
state: Pennsylvania
city: Austin
country: United States
facility: Arcutis Clinical Site 162
state: Texas
city: College Station
country: United States
facility: Arcutis Clinical Site 104
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 164
state: Texas
city: Pflugerville
country: United States
facility: Arcutis Clinical Site 163
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 161
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 110
state: Texas
city: Norfolk
country: United States
facility: Arcutis Clinical Site 169
state: Virginia
city: Westmead
country: Australia
facility: Arcutis Clinical Site 306
state: New South Wales
city: East Melbourne
country: Australia
facility: Arcutis Clinical Site 303
state: Victoria
city: Surrey
country: Canada
facility: Arcutis Clinical Site 207
state: British Columbia
city: Ajax
country: Canada
facility: Arcutis Clinical Site 205
state: Ontario
city: Barrie
country: Canada
facility: Arcutis Clinical Site 218
state: Ontario
city: London
country: Canada
facility: Arcutis Clinical Site 103
state: Ontario
city: Mississauga
country: Canada
facility: Arcutis Clinical Site 133
state: Ontario
city: Oakville
country: Canada
facility: Arcutis Clinical Site 165
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Clinical Site 109
state: Ontario
city: Richmond Hill
country: Canada
facility: Arcutis Clinical Site 241
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Clinical Site 106
state: Ontario
city: Montreal
country: Canada
facility: Arcutis Clinical Site 242
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: