Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
NB-NM026-2198-101 Enrolling

Moderate-to-Severe Atopic Dermatitis – Eczema Trial (12 Weeks)


Treatment: Injection Age: 18 Years


Who can participate?

Adults 18 years of age or older with moderate-to-severe Atopic Dermatitis (AD) – Eczema are needed for this clinical trial.

Inclusion Criteria:

  • Have a physician-confirmed chronic AD for at least 6 months prior to study screening.
  • Have AD lesions covering 10%* or more of body surface area (BSA)
  • Must agree to apply an additive-free, bland, non-prescription emollient at least once a day throughout the study.

* 1% of your body surface area is roughly equal to the palm of your hand (no wrists or fingers)

What are the benefits?

As a participant in our research trial, you will receive an investigational treatment (active study drug) or placebo via injection entirely free of cost. All study-related assessments will also be provided at no charge. In addition, you may also be eligible for reimbursement of study-related expenses.

How long will the study last?

  • 12 weeks with 15 visits to the study center and 2 phone visits.

 


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Wei Jing Loo

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 23, 2024

Official Title

A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Exploratory Clinical Activity of NM26-2198 in Healthy Volunteers and in Adult Patients With Atopic Dermatitis

ClinicalTrials.gov ID

NCT05859724

Sponsor

Numab Therapeutics AG

Study Description

  • Brief Summary:

    This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy volunteers and adult patients with moderate to-severe AD to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single (SAD) and multiple doses (MAD) of NM26-2198.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Other: Placebo
    Biological: NM26-2198
  • Phase:

    Phase 1

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent or Japanese descent having all four Japanese grandparents born in Japan.
SAD and MAD in Healthy Volunteers: Male or female aged 18 to 55 years; MAD: Male or female ≥18 years of age.
ALL COHORTS: Weight of 45 kg to 100 kg and BMI of 18.0 to 30.0 kg/m2.
SAD and MAD in Healthy Volunteers: Non-childbearing, non-breastfeeding females or males willing to use double barrier contraception or abstention from sex and sperm donation during the study; MAD: Males willing to use double barrier contraception or abstention from sex and sperm donation during the study; non-childbearing females or females of childbearing potential using protocol-defined method contraception, and who is not pregnant, lactating, or breastfeeding.
MAD: Diagnosis of chronic AD.
MAD: EASI score ≥16.
MAD: vIGA-AD™ score of ≥3.
MAD: Atopic lesions cover ≥10% of body surface area (BSA).
MAD: PP-NRS score ≥4.
MAD: Daily use of non-prescription emollient.

Note: Other protocol-defined Inclusion criteria apply.

Exclusion Criteria:

SAD and MAD in Healthy Volunteers: Any clinically-relevant medical history or lab abnormality, including positive test for SARS-CoV-2, Hepatitis B or C, or HIV; MAD: Clinically-significant, abnormal laboratory findings, or positive test for SARS-CoV-2, Hepatitis B or C, or HIV.
ALL COHORTS: Clinically important ECG abnormalities or history/evidence thereof.
SAD and MAD in Healthy Volunteers: Use of prescription or non-prescription medications (except occasional use of paracetamol).
MAD: Diagnosis of protocol-specified skin diseases other than AD, or history of other significant skin condition that could interfere with study assessments.
MAD: History or ongoing allergy/hypersensitivity or history, or history of hypersensitivity to biological drugs.
MAD: Recent receipt of immunoglobulin or blood products.
MAD: Recent treatment with protocol-specified investigational treatments, or any prior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or other protocol-specified drugs.
MAD: AD with recent ocular involvement requiring chronic ocular corticosteroid treatment.
MAD: Chronic pruritis due to conditions other than AD.
MAD: Acute AD superinfection, recent superficial skin infection, or other chronic/acute infection requiring protocol-defined treatments.
MAD: Recent use of sedating antihistimines, systemic corticosteroids, cytotoxic treatments, other immunosuppressive/immunomodulating agents, and other protocol-specified prohibited medications.
MAD: Recent topical corticosteroid or prescription moisturizer use.

Note: Other protocol-defined Exclusion criteria apply.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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