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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04378569




Registration number
NCT04378569
Ethics application status
Date submitted
30/04/2020
Date registered
7/05/2020
Date last updated
26/02/2021

Titles & IDs
Public title
Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
Scientific 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
Secondary ID [1] 0 0
ARQ-252-205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hand Eczema 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARQ-252 cream 0.3%
Treatment: Drugs - ARQ-252 cream 0.1%
Treatment: Drugs - ARQ-252 Vehicle Cream

Active Comparator: ARQ-252 cream 0.3% QD (once daily) - Active Comparator

Active Comparator: ARQ-252 cream 0.3% BID (twice daily) - Active Comparator

Active Comparator: ARQ-252 cream 0.1% QD (once daily) - Active Comparator

Placebo Comparator: Vehicle cream BID (twice daily) - Placebo Comparator

Placebo Comparator: Vehicle cream QD (once daily) - Placebo Comparator


Treatment: Drugs: ARQ-252 cream 0.3%
ARQ-252 cream 0.3%

Treatment: Drugs: ARQ-252 cream 0.1%
ARQ-252 cream 0.1%

Treatment: Drugs: ARQ-252 Vehicle Cream
ARQ-252 Vehicle Cream

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1: Safety, as measured by incidence of adverse events - The number of subjects reporting treatment-emergent adverse events
Timepoint [1] 0 0
Week 3
Primary outcome [2] 0 0
Cohort 1: Safety, as measured by severity of adverse events - The severity of treatment-emergent adverse events
Timepoint [2] 0 0
Week 3
Primary outcome [3] 0 0
Cohort 1: Safety, as measured by changes in hematology laboratory parameters - Number of subjects with changes in hematology laboratory parameters
Timepoint [3] 0 0
Week 3
Primary outcome [4] 0 0
Cohort 1: Safety, as measured by changes in chemistry laboratory parameters - Number of subjects with changes in chemistry laboratory parameters
Timepoint [4] 0 0
Week 3
Primary outcome [5] 0 0
Cohort 1: Safety, as measured by tolerability - The incidence of application site reactions as assessed by both the investigator and subject
Timepoint [5] 0 0
Week 3
Primary outcome [6] 0 0
Cohort 1: Safety, as measured by pharmacokinetics - Plasma drug concentrations at pre-dose will be summarized using descriptive statistics
Timepoint [6] 0 0
Week 3
Primary outcome [7] 0 0
Cohort 2: Investigator's Global Assessment (IGA) score of 'clear' or 'almost clear' at Week 12 - The IGA is a static evaluation of qualitative overall chronic hand eczema severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.
Timepoint [7] 0 0
Week 12
Secondary outcome [1] 0 0
Cohort 2: The rate of achievement of Investigator's Global Assessment (IGA) of 'clear' or 'almost clear' PLUS at least a 2-point improvement from Baseline - The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Timepoint [1] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [2] 0 0
Cohort 2: The rate of achievement of at least a 2-point improvement in Investigator's Global Assessment (IGA) from Baseline - The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Timepoint [2] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [3] 0 0
Cohort 2: Achievement of Investigator's Global Assessment (IGA) of 'clear' or 'almost clear' - The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Timepoint [3] 0 0
Weeks 2, 4, and 8
Secondary outcome [4] 0 0
Cohort 2: Time to Investigator's Global Assessment (IGA) of 'clear' or 'almost clear' - The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Cohort 2: Change in Time to Investigator's Global Assessment (IGA) score compared to Baseline - The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Timepoint [5] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [6] 0 0
Cohort 2: Change in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score compared to Baseline - The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Timepoint [6] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [7] 0 0
Cohort 2: The rate of achievement of =4-point reduction from Baseline in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score in subjects with Baseline WI-NRS pruritus score of at least 4 - The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Timepoint [7] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [8] 0 0
Cohort 2: Time to the first achievement of =4-point reduction from Baseline in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score in subjects with Baseline WI-NRS pruritus score of at least 4 - The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Cohort 2: Percent change in Hand Eczema Severity Index (HECSI) score compared to Baseline - HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area).
Timepoint [9] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [10] 0 0
Cohort 2: Change in Numerical Rating Scale (NRS) for Pain score compared to Baseline - The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Timepoint [10] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [11] 0 0
Cohort 2: The rate of achievement of =4-point reduction from Baseline in Pain Numerical Rating Scale (NRS) score in subjects with Baseline Pain NRS score of at least 4 - The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Timepoint [11] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [12] 0 0
Cohort 2: Time to the first achievement of =4-point reduction from Baseline in Pain Numerical Rating Scale (NRS) score in subjects with Baseline Pain NRS score of at least 4 - The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
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 out 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.
Timepoint [13] 0 0
Weeks 2, 4, 8, 12, 13
Secondary outcome [14] 0 0
Cohort 2: Percent Body Surface Area (BSA) affected by disease and percent change from baseline in BSA affected by disease - The BSA affected by chronic hand eczema will be determined by the subject's hand method, where the subject's hand (including fingers) surface area is assumed to equal 1% of body surface area.
Timepoint [14] 0 0
Weeks 2, 4, 8, 12

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Arcutis Clinical Site 306 - Westmead
Recruitment hospital [2] 0 0
Arcutis Clinical Site 303 - East Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Montreal

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arcutis Biotherapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand
eczema
Trial website
https://clinicaltrials.gov/show/NCT04378569
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Berk, MD
Address 0 0
Arcutis Biotherapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications