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

Chronic Hand Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378569
• Other study ID #: ARQ-252-205
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 20, 2020
• Est. completion date: February 24, 2021

Study information

• Verified date: April 2024
• Source: Arcutis Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hand Eczema
• Eczema

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Arcutis Clinical Site 303	East Melbourne	Victoria
Australia	Arcutis Clinical Site 306	Westmead	New South Wales
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 242	Montreal
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 207	Surrey	British Columbia
Canada	Arcutis Clinical Site 106	Waterloo	Ontario
United States	Arcutis Clinical Site 162	Austin	Texas
United States	Arcutis Clinical Site 174	Aventura	Florida
United States	Arcutis Clinical Site 239	Beverly Hills	California
United States	Arcutis Clinical Site 104	College Station	Texas
United States	Arcutis Clinical Site 167	Coral Gables	Florida
United States	Arcutis Clinical Site 212	Detroit	Michigan
United States	Arcutis Clinical Site 225	Encino	California
United States	Arcutis Clinical Site 112	Fremont	California
United States	Arcutis Clinical Site 115	High Point	North Carolina
United States	Arcutis Clinical Site 164	Houston	Texas
United States	Arcutis Clinical Site 214	Indianapolis	Indiana
United States	Arcutis Clinical Site 120	Irvine	California
United States	Arcutis Clinical Site 217	Louisville	Kentucky
United States	Arcutis Clinical Site 213	Metairie	Louisiana
United States	Arcutis Clinical Site 216	New Brighton	Minnesota
United States	Arcutis Clinical Site 171	New York	New York
United States	Arcutis Clinical Site 169	Norfolk	Virginia
United States	Arcutis Clinical Site 163	Pflugerville	Texas
United States	Arcutis Clinical Site 135	Pittsburgh	Pennsylvania
United States	Arcutis Clinical Site 173	Portland	Oregon
United States	Arcutis Clinical Site 125	Rockville	Maryland
United States	Arcutis Clinical Site 110	San Antonio	Texas
United States	Arcutis Clinical Site 161	San Antonio	Texas
United States	Arcutis Clinical Site 104	Sanford	Florida
United States	Arcutis Clinical Site 208	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Arcutis Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Number of Participants With =1 Adverse Event (AE)	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.	Up to 3 weeks
Primary	Cohort 1: Number of Participants With an Application Site Reaction	The number of Cohort 1 participants with AEs coded as application site events is reported.	Up to 3 weeks
Primary	Cohort 1: Number of Participants With =1 Serious Adverse Event (SAE)	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.	Up to 3 weeks
Primary	Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters	The number of Cohort 1 participants with a significant change in hematology is reported.	Up to 3 weeks
Primary	Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters	The number of Cohort 1 participants with a significant change in chemistry is reported.	Up to 3 weeks
Primary	Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at 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.	Week 12
Secondary	Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline	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.	Weeks 2, 4, 8 and 12
Secondary	Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline	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.	Weeks 2, 4, 8 and 12
Secondary	Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'	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.	Weeks 2, 4, and 8
Secondary	Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score	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.	Weeks 2, 4, 8, and 12
Secondary	Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score	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.	Weeks 2, 4, 8, and 12
Secondary	Cohort 2: Achievement of =4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score	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.	Weeks 2, 4, 8, and 12
Secondary	Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score	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.	Weeks 2, 4, 8, and 12
Secondary	Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score	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.	Weeks 2, 4, 8, and 12
Secondary	Cohort 2: The Rate of Achievement of =4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score	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.	Weeks 2, 4, 8, and 12
Secondary	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 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').	Weeks 2, 4, 8, 12, 13
Secondary	Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease	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).	Weeks 2, 4, 8, 12