Evaluation of NM26-2198 in Healthy Subjects and in Patients With Moderate-to-severe Atopic Dermatitis (AD)

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT05859724

Run by

Yellow Jersey Therapeutics AG

People needed

126

Starts

2023-05-10

Expected to finish

2024-10-17

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• First OC Dermatology Research — Fountain Valley, California, United States
• California Clinical Trials Medical Group (CCTMG) managed by Parexel — Glendale, California, United States
• TCR Medical Corporation — San Diego, California, United States
• D&H Tamarac Research Center — Tamarac, Florida, United States
• Sadick Research Group — New York, New York, United States
• Paddington Testing Co. — Philadelphia, Pennsylvania, United States
• DermEffects — London, Ontario, Canada
• Centre de Recherche Saint-Louis — Québec, Canada
• Universitätsmedizin Mainz — Mainz, Hesse, Germany
• Universitätsklinikum Carl Gustav Carus — Dresden, Saxony, Germany
• UK-SH - Lübeck — Lübeck, Schleswig-Holstein, Germany
• COPERNICUS Podmiot Leczniczy Sp. z o.o., Szpital Sw. Wojciecha — Gdansk, Poland
• Uniwersytecki Szpital Kliniczny im. F.Chopina w Rzeszowie — Rzeszów, Poland
• Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych — Warsaw, Poland
• Klinika Ambroziak Dermatologia — Warsaw, Poland

Full record on ClinicalTrials.gov

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