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

NCT04378569 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ARQ-252-205
• Study Type: interventional
• Target: 230
• Locations: 3 countries
• Sites: 37

Brief Summary

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

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline

  Weeks 2, 4, 8 and 12

• Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline

  Weeks 2, 4, 8 and 12

• Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'

  Weeks 2, 4, and 8

• Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score

  Weeks 2, 4, 8, and 12

• Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score

  Weeks 2, 4, 8, and 12

Study Arms (5)

ARQ-252 cream 0.3% QD (once daily)

ACTIVE COMPARATOR

Active Comparator

Drug: ARQ-252 cream 0.3%

ARQ-252 cream 0.3% BID (twice daily)

ACTIVE COMPARATOR

Active Comparator

Drug: ARQ-252 cream 0.3%

ARQ-252 cream 0.1% QD (once daily)

ACTIVE COMPARATOR

Active Comparator

Drug: ARQ-252 cream 0.1%

Vehicle cream BID (twice daily)

PLACEBO COMPARATOR

Placebo Comparator

Drug: ARQ-252 Vehicle Cream

Vehicle cream QD (once daily)

PLACEBO COMPARATOR

Placebo Comparator

Drug: ARQ-252 Vehicle Cream

Interventions

ARQ-252 cream 0.3% DRUG

ARQ-252 cream 0.3%

ARQ-252 cream 0.3% BID (twice daily); ARQ-252 cream 0.3% QD (once daily)

ARQ-252 cream 0.1% DRUG

ARQ-252 cream 0.1%

ARQ-252 cream 0.1% QD (once daily)

ARQ-252 Vehicle Cream DRUG

ARQ-252 Vehicle Cream

Vehicle cream BID (twice daily); Vehicle cream QD (once daily)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (37)

Arcutis Clinical Site 239

Beverly Hills, California, 90212, United States

Location

Arcutis Clinical Site 225

Encino, California, 91436, United States

Location

Arcutis Clinical Site 112

Fremont, California, 94538, United States

Location

Arcutis Clinical Site 120

Irvine, California, 92797, United States

Location

Arcutis Clinical Site 208

Santa Monica, California, 90404, United States

Location

Arcutis Clinical Site 174

Aventura, Florida, 33180, United States

Location

Arcutis Clinical Site 167

Coral Gables, Florida, 33134, United States

Location

Arcutis Clinical Site 104

Sanford, Florida, 32771, United States

Location

Arcutis Clinical Site 214

Indianapolis, Indiana, 46250, United States

Location

Arcutis Clinical Site 217

Louisville, Kentucky, 40217, United States

Location

Arcutis Clinical Site 213

Metairie, Louisiana, 70006, United States

Location

Arcutis Clinical Site 125

Rockville, Maryland, 20850, United States

Location

Arcutis Clinical Site 212

Detroit, Michigan, 48202, United States

Location

Arcutis Clinical Site 216

New Brighton, Minnesota, 55112, United States

Location

Arcutis Clinical Site 171

New York, New York, 10029, United States

Location

Arcutis Clinical Site 115

High Point, North Carolina, 27262, United States

Location

Arcutis Clinical Site 173

Portland, Oregon, 97210, United States

Location

Arcutis Clinical Site 135

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Clinical Site 162

Austin, Texas, 78759, United States

Location

Arcutis Clinical Site 104

College Station, Texas, 77845, United States

Location

Arcutis Clinical Site 164

Houston, Texas, 77056, United States

Location

Arcutis Clinical Site 163

Pflugerville, Texas, 78660, United States

Location

Arcutis Clinical Site 161

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 110

San Antonio, Texas, 78218, United States

Location

Arcutis Clinical Site 169

Norfolk, Virginia, 23502, United States

Location

Arcutis Clinical Site 306

Westmead, New South Wales, 2145, Australia

Location

Arcutis Clinical Site 303

East Melbourne, Victoria, 3002, Australia

Location

Arcutis Clinical Site 207

Surrey, British Columbia, Canada

Location

Arcutis Clinical Site 205

Ajax, Ontario, Canada

Location

Arcutis Clinical Site 218

Barrie, Ontario, Canada

Location

Arcutis Clinical Site 103

London, Ontario, Canada

Location

Arcutis Clinical Site 133

Mississauga, Ontario, Canada

Location

Arcutis Clinical Site 165

Oakville, Ontario, Canada

Location

Arcutis Clinical Site 109

Peterborough, Ontario, Canada

Location

Arcutis Clinical Site 241

Richmond Hill, Ontario, Canada

Location

Arcutis Clinical Site 106

Waterloo, Ontario, Canada

Location

Arcutis Clinical Site 242

Montreal, Canada

Location

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 7, 2020
• Study Start: April 20, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10); AU (2); US (25)