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New treatment option for Atopic Dermatitis (AD)
Official title Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
ClinicalTrials.gov ID: NCT07453602
What this study is testing
What is ARQ-234?
ARQ-234 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atopic dermatitis (ad).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- (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...
You likely can't join if
- (All Participants):
- Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per...
- 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).
See the full eligibility 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...
- Body weight by study part: Part A (SAD) \& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive) 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).
- (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.
The study team makes the final eligibility decision.
Where it's taking place
- Fair Lawn, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fair Lawn, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.