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

Arcutis Biotherapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hand Eczema

Treatments: Drug: ARQ-252 cream 0.3%; Drug: ARQ-252 Vehicle Cream; Drug: ARQ-252 cream 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04378569

ARQ-252-205

Details and patient eligibility

About

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

Full 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

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 5 patient groups, including a placebo group

ARQ-252 cream 0.3% QD (once daily)

Active Comparator group

Description:

Active Comparator

Treatment:

Drug: ARQ-252 cream 0.3%

ARQ-252 cream 0.3% BID (twice daily)

Active Comparator group

Description:

Active Comparator

Treatment:

Drug: ARQ-252 cream 0.3%

ARQ-252 cream 0.1% QD (once daily)

Active Comparator group

Description:

Active Comparator

Treatment:

Drug: ARQ-252 cream 0.1%

Vehicle cream BID (twice daily)

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: ARQ-252 Vehicle Cream

Vehicle cream QD (once daily)

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: ARQ-252 Vehicle Cream