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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04378569
Ethics application status
Date submitted
30/04/2020
Date registered
7/05/2020

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: Number of Participants With =1 Adverse Event (AE)
Timepoint [1] 0 0
Up to 3 weeks
Primary outcome [2] 0 0
Cohort 1: Number of Participants With an Application Site Reaction
Timepoint [2] 0 0
Up to 3 weeks
Primary outcome [3] 0 0
Cohort 1: Number of Participants With =1 Serious Adverse Event (SAE)
Timepoint [3] 0 0
Up to 3 weeks
Primary outcome [4] 0 0
Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
Timepoint [4] 0 0
Up to 3 weeks
Primary outcome [5] 0 0
Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
Timepoint [5] 0 0
Up to 3 weeks
Primary outcome [6] 0 0
Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [1] 0 0
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
Timepoint [1] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [2] 0 0
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
Timepoint [2] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [3] 0 0
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
Timepoint [3] 0 0
Weeks 2, 4, and 8
Secondary outcome [4] 0 0
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
Timepoint [4] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [5] 0 0
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Timepoint [5] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [6] 0 0
Cohort 2: Achievement of =4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
Timepoint [6] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [7] 0 0
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
Timepoint [7] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [8] 0 0
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
Timepoint [8] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [9] 0 0
Cohort 2: The Rate of Achievement of =4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
Timepoint [9] 0 0
Weeks 2, 4, 8, and 12
Secondary outcome [10] 0 0
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
Timepoint [10] 0 0
Weeks 2, 4, 8, 12, 13
Secondary outcome [11] 0 0
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
Timepoint [11] 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
Sex
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
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
20/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2021
Sample size
Target
Accrual to date
Final
230
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04378569