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:
* 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?
London - DermEffects
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Last Update Posted: December 10, 2023
NCT05859724
Numab Therapeutics AG
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 Japanese and non-Asian 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: PlaceboPhase:
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: Male or female aged 18 to 55 years; MAD: Male or female ≥18 years of age.
Weight of 45 kg to 100 kg and BMI of 18.0 to 30.0 kg/m2.
SAD: 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: 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.
Clinically important ECG abnormalities or history/evidence thereof.
SAD: 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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