Phase 1 Eczema Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to sign a written consent form agreeing to take part.
• Adults aged 18 to 65 years old at the time of signing consent.
• People who are generally healthy, with no significant health problems found during initial medical checks, physical examination, vital signs, heart tracing (ECG), or blood/urine tests.
• Women who could become pregnant must have negative pregnancy tests at the start of the trial and agree to use highly effective contraception plus a barrier method throughout the trial and for 4 months after the last dose; men who are sexually active with a pregnant partner or a partner who could become pregnant must agree to use condoms throughout the trial and for 4 months after the last dose.
• People within certain weight ranges depending on the part of the trial: Parts A and B require a body weight of 50–100 kg; Part C allows 50–125 kg.

For people with atopic dermatitis (eczema) joining specific parts of the trial (Part A Cohorts 6–7, Part B, or Part C), additional criteria apply:

• A confirmed diagnosis of moderate-to-severe atopic dermatitis for at least 6 months before the screening visit.
• Skin condition must meet minimum severity levels at the start of the trial, measured using standard scoring tools — the specific thresholds differ depending on the part of the trial (confirm exact requirements with the trial site).
• Previous treatments applied directly to the skin have not worked well enough, have caused intolerance, or are considered medically unsuitable; in some cases, a previous failure of a systemic (whole-body) treatment within the last year may also meet this requirement (confirm with trial site).

Who may not be able to join:

• People with any significant medical or psychiatric condition that the study doctor considers could increase health risks, affect participation, or interfere with results.
• People with significant kidney problems or clinically meaningful liver problems as defined by the trial protocol.
• People with significantly low blood cell counts or abnormal liver test results at the screening visit.
• People with a history of a severe allergic reaction (anaphylaxis) or serious hypersensitivity, including significant reactions to local anaesthetics.
• People with a history of a suicide attempt, or who the study doctor considers to currently be at significant risk.
• People with a history of ongoing or significant infections, or who test positive at screening for hepatitis B, hepatitis C, HIV, or tuberculosis (including a positive QuantiFERON test or any history of active or latent tuberculosis).
• People with known or suspected immune system suppression, a history of serious opportunistic infections, or a pattern of unusually frequent, severe, or prolonged infections.
• People with a recent case of shingles (herpes zoster) that the study doctor considers a risk or that could affect how results are interpreted.
• People who have had a cancer diagnosis within the 5 years before the screening visit.
• People who test positive on a urine drug screen at screening (for Parts A and B), or who have a history of drug or alcohol misuse within the past 12 months, or any other condition the study doctor considers likely to affect compliance.
• People who are unable to stop taking medications or undergoing treatments that are not permitted during the trial.
• People who have had major surgery within 4 weeks before the start of the trial, or who have major surgery planned during their participation.
• People who have taken part in another clinical trial or received an experimental treatment within 12 weeks (or 5 half-lives of the previous drug, whichever is longer) before the start of the trial.
• People who have received a cell-depleting therapy (such as rituximab) within 6 months before the start of the trial, or until their white blood cell levels return to normal, whichever takes longer.
• People who have received blood products within 4 weeks before the start of the trial, or who have planned blood product use during participation.
• People who have received a live or live-attenuated vaccine within 28 days before the start of the trial, or who have a live vaccine planned during the study.
• People who are pregnant, breastfeeding, or planning a pregnancy during the trial or within 4 months after the last dose.
• People with a known or suspected allergy to ARQ-234 or any of its ingredients.
• People who are unable to communicate or understand the local language, or who the study doctor considers otherwise unsuitable for participation.
• People who are a family member of a staff member working on the study or employed by the sponsoring organisation.

For people with atopic dermatitis joining specific parts of the trial, additional exclusion criteria apply:

• People who have another skin condition that would interfere with the assessment of their eczema.
• People with an active infection anywhere in the body, including infected eczema, or who have required oral or intravenous antibiotics or antimicrobials within 14 days before the start of the trial.
• People who have used phototherapy or a tanning bed within 4 weeks before the start of the trial.
• People who have used a biologic medicine (an injectable or infused treatment targeting the immune system) for atopic dermatitis within 3 months or 5 half-lives before the start of the trial, whichever is longer.
• People who are expected to need urgent rescue treatment for their eczema within the first 2 weeks after the trial begins.
• People who have had a skin infection caused by the herpes virus (eczema herpeticum) within the past 12 months, or who have had two or more episodes at any time in the past.

Important: Always verify eligibility with the trial site directly before applying.