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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378569
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Hand Eczema Drug: ARQ-252 cream 0.3% Drug: ARQ-252 cream 0.1% Drug: ARQ-252 Vehicle Cream Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: ARQ-252 cream 0.3% QD (once daily)
Active Comparator
Drug: ARQ-252 cream 0.3%
ARQ-252 cream 0.3%

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

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

Placebo Comparator: Vehicle cream BID (twice daily)
Placebo Comparator
Drug: ARQ-252 Vehicle Cream
ARQ-252 Vehicle Cream

Placebo Comparator: Vehicle cream QD (once daily)
Placebo Comparator
Drug: ARQ-252 Vehicle Cream
ARQ-252 Vehicle Cream




Primary Outcome Measures :
  1. Cohort 1: Safety, as measured by incidence of adverse events [ Time Frame: Week 3 ]
    The number of subjects reporting treatment-emergent adverse events

  2. Cohort 1: Safety, as measured by severity of adverse events [ Time Frame: Week 3 ]
    The severity of treatment-emergent adverse events

  3. Cohort 1: Safety, as measured by changes in hematology laboratory parameters [ Time Frame: Week 3 ]
    Number of subjects with changes in hematology laboratory parameters

  4. Cohort 1: Safety, as measured by changes in chemistry laboratory parameters [ Time Frame: Week 3 ]
    Number of subjects with changes in chemistry laboratory parameters

  5. Cohort 1: Safety, as measured by tolerability [ Time Frame: Week 3 ]
    The incidence of application site reactions as assessed by both the investigator and subject

  6. Cohort 1: Safety, as measured by pharmacokinetics [ Time Frame: Week 3 ]
    Plasma drug concentrations at pre-dose will be summarized using descriptive statistics

  7. Cohort 2: Investigator's Global Assessment (IGA) score of 'clear' or 'almost clear' at Week 12 [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Weeks 2, 4, 8 and 12 ]
    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.

  2. Cohort 2: The rate of achievement of at least a 2-point improvement in Investigator's Global Assessment (IGA) from Baseline [ Time Frame: Weeks 2, 4, 8 and 12 ]
    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.

  3. Cohort 2: Achievement of Investigator's Global Assessment (IGA) of 'clear' or 'almost clear' [ Time Frame: Weeks 2, 4, and 8 ]
    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.

  4. Cohort 2: Time to Investigator's Global Assessment (IGA) of 'clear' or 'almost clear' [ Time Frame: Week 12 ]
    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.

  5. Cohort 2: Change in Time to Investigator's Global Assessment (IGA) score compared to Baseline [ Time Frame: Weeks 2, 4, 8, and 12 ]
    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.

  6. Cohort 2: Change in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score compared to Baseline [ Time Frame: Weeks 2, 4, 8, and 12 ]
    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").

  7. 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 [ Time Frame: Weeks 2, 4, 8, and 12 ]
    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").

  8. 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 [ Time Frame: Week 12 ]
    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").

  9. Cohort 2: Percent change in Hand Eczema Severity Index (HECSI) score compared to Baseline [ Time Frame: Weeks 2, 4, 8, and 12 ]
    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).

  10. Cohort 2: Change in Numerical Rating Scale (NRS) for Pain score compared to Baseline [ Time Frame: Weeks 2, 4, 8, and 12 ]
    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'.

  11. 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 [ Time Frame: Weeks 2, 4, 8, and 12 ]
    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'.

  12. 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 [ Time Frame: Week 12 ]
    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'.

  13. Cohort 2: Change from Baseline in overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score at each visit [ Time Frame: Weeks 2, 4, 8, 12, 13 ]
    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.

  14. Cohort 2: Percent Body Surface Area (BSA) affected by disease and percent change from baseline in BSA affected by disease [ Time Frame: Weeks 2, 4, 8, 12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378569


Contacts
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Contact: David Berk, MD 805-418-5006 ext 5 studyinquiry@arcutis.com

Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
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Study Director: David Berk, MD Arcutis Biotherapeutics, Inc.
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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04378569    
Other Study ID Numbers: ARQ-252-205
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous