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New eczema drug enters first human tests

NCT ID NCT07453602

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinical Site 101

    RECRUITING

    Fair Lawn, New Jersey, 07410, United States

    Contact Email: •••••@•••••

  • Clinical Site 102

    RECRUITING

    College Station, Texas, 77845, United States

    Contact Email: •••••@•••••

  • Clinical Site 104

    RECRUITING

    San Antonio, Texas, 78213, United States

    Contact Email: •••••@•••••

  • Clinical Site 106

    RECRUITING

    Plainfield, Indiana, 46168, United States

    Contact Email: •••••@•••••

  • Clinical Site 109

    RECRUITING

    South Jordan, Utah, 84095, United States

    Contact Email: •••••@•••••

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