New eczema drug enters first human tests
NCT ID NCT07453602
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This early-stage trial is testing a new injectable drug called ARQ-234 in healthy volunteers and people with moderate to severe eczema. The main goals are to check safety and how the body processes the drug, while also looking for early signs that it might improve eczema symptoms. Around 125 participants will receive either the drug or a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARQ-234 (an injectable biologic drug)
- What this could lead to
- If successful, this could point toward a new treatment option for people with moderate to severe eczema.
- What could go wrong
- This is a very early Phase 1 trial, so the drug may not prove safe or effective. It is also small and includes healthy volunteers, so results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (All Participants): * Able and willing to provide written informed consent. * Adults 18-65 years (inclusive) at consent. * Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator). * Contraception requirements: Females of childbearing potential: negative pregnancy tests at screening and baseline and agree to use highly effective contraception (plus barrier method) during the study and for 4 months after last dose. Males if sexually active with a pregnant partner or a female of childbearing potential, agree to condom use during the study and for 4 months after last dose. * Body weight by study part: Part A (SAD) \& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive) Inclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C): * Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening. * Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-AD 3-4, EASI ≥16 at Baseline. * Inadequate response, intolerance, or medical inappropriateness of topical AD therapies (and/or prior systemic AD therapy failure within the last year may qualify as inadequate response). Exclusion Criteria (All Participants): * Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator). * Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions). * Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol). * History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics). * History of attempted suicide or significant current risk, per investigator). * Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB). * Known/suspected immunosuppression or history of invasive opportunistic infections or unusually frequent/recurrent/prolonged infections (per investigator). * Recent herpes zoster that poses risk or may affect interpretation (per investigator). * Malignancy within 5 years prior to screening * Positive urine drug screen at screening (Part A/Part B only) or drug/alcohol abuse within 12 months, or other condition likely to impair compliance (per investigator). * Unable to discontinue prohibited medications/treatments per protocol. * Major surgery within 4 weeks prior to baseline or planned during participation. * Participation in another trial or receipt of investigational product within 12 weeks (or 5 half-lives, whichever longer) before baseline. * Prior cell-depleting therapy (e.g., rituximab) within 6 months prior to baseline (or until lymphocytes normalize, whichever longer). * Blood products within 4 weeks prior to baseline or planned during participation. * Live (attenuated) vaccines within 28 days prior to baseline or planned during the study. * Pregnant or breastfeeding, or planning pregnancy during the study or within 4 months after last dose. * Known/suspected allergy to ARQ-234 or its excipients. * Unable to communicate/understand the local language or otherwise unsuitable per investigator. * Family member of study staff or sponsor. Exclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C): * Skin disease(s) other than AD that would interfere with assessments. * Active systemic/local infection, including actively infected AD, or infection requiring oral/IV antimicrobials within 14 days before baseline. * Phototherapy/tanning bed use within 4 weeks prior to baseline. * Biologic therapy for AD within 3 months or 5 half-lives (whichever longer) prior to baseline. * Expected need for rescue therapy for AD within the first 2 weeks after baseline. * History of eczema herpeticum within 12 months or ≥2 prior episodes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Clinical Site 101
RECRUITINGFair Lawn, New Jersey, 07410, United States
Contact Email: •••••@•••••
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Clinical Site 102
RECRUITINGCollege Station, Texas, 77845, United States
Contact Email: •••••@•••••
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Clinical Site 104
RECRUITINGSan Antonio, Texas, 78213, United States
Contact Email: •••••@•••••
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Clinical Site 106
RECRUITINGPlainfield, Indiana, 46168, United States
Contact Email: •••••@•••••
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Clinical Site 109
RECRUITINGSouth Jordan, Utah, 84095, United States
Contact Email: •••••@•••••
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