Is NCT07453602 recruiting in Fair Lawn, NJ?

Yes, NCT07453602 is currently recruiting participants at its Fair Lawn, NJ location. This atopic dermatitis (ad) clinical trial is actively enrolling qualified participants.

How do I join the atopic dermatitis (ad) clinical trial in Fair Lawn?

To join this clinical trial in Fair Lawn, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Fair Lawn clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Atopic Dermatitis (AD) Clinical Trial in Fair Lawn, NJ

About This Atopic Dermatitis (AD) Study in Fair Lawn

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). Healthy volunteers will participate in Single Ascending Dose (SAD) Cohorts 1-5. Participants with moderate to severe AD will be enrolled in SAD Cohorts 6-7, Multiple Ascending Dose (MAD) Cohorts, and a Proof-of-Concept (POC) expansion cohort.

Sponsor: Arcutis Biotherapeutics, Inc.

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fair Lawn?

Yes, this clinical trial (NCT07453602) has an active research site in Fair Lawn, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Atopic Dermatitis (AD) Treatment Options in Fair Lawn, NJ

If you're searching for atopic dermatitis (ad) treatment options in Fair Lawn, NJ, this clinical trial (NCT07453602) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fair Lawn research site is actively enrolling participants for this clinical trial. You'll receive care from experienced atopic dermatitis (ad) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all atopic dermatitis (ad) clinical trials near you to find additional studies recruiting in your area.

Atopic Dermatitis (AD) Clinical Trial in Fair Lawn, NJ

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