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

Completed · Phase 1/Phase 2

Conditions studied: Chronic Hand Eczema

In brief

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

Key facts

Study ID

NCT04378569

Run by

Arcutis Biotherapeutics, Inc.

People needed

230

Starts

2020-04-20

Expected to finish

2021-02-24

Last updated by the study team

2024-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Arcutis Clinical Site 239 — Beverly Hills, California, United States
• Arcutis Clinical Site 225 — Encino, California, United States
• Arcutis Clinical Site 112 — Fremont, California, United States
• Arcutis Clinical Site 120 — Irvine, California, United States
• Arcutis Clinical Site 208 — Santa Monica, California, United States
• Arcutis Clinical Site 174 — Aventura, Florida, United States
• Arcutis Clinical Site 167 — Coral Gables, Florida, United States
• Arcutis Clinical Site 104 — Sanford, Florida, United States
• Arcutis Clinical Site 214 — Indianapolis, Indiana, United States
• Arcutis Clinical Site 217 — Louisville, Kentucky, United States
• Arcutis Clinical Site 213 — Metairie, Louisiana, United States
• Arcutis Clinical Site 125 — Rockville, Maryland, United States
• Arcutis Clinical Site 212 — Detroit, Michigan, United States
• Arcutis Clinical Site 216 — New Brighton, Minnesota, United States
• Arcutis Clinical Site 171 — New York, New York, United States
• Arcutis Clinical Site 115 — High Point, North Carolina, United States
• Arcutis Clinical Site 173 — Portland, Oregon, United States
• Arcutis Clinical Site 135 — Pittsburgh, Pennsylvania, United States
• Arcutis Clinical Site 162 — Austin, Texas, United States
• Arcutis Clinical Site 104 — College Station, Texas, United States
• Arcutis Clinical Site 164 — Houston, Texas, United States
• Arcutis Clinical Site 163 — Pflugerville, Texas, United States
• Arcutis Clinical Site 161 — San Antonio, Texas, United States
• Arcutis Clinical Site 110 — San Antonio, Texas, United States
• Arcutis Clinical Site 169 — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.