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

Last updated: March 28, 2025
Sponsor: Yellow Jersey Therapeutics AG
Overall Status: Terminated

Phase

1

Condition

Rosacea

Rash

Hives (Urticaria)

Treatment

Placebo

NM26-2198

Clinical Study ID

NCT05859724
NB-NM026-2198-101
2023-503577-38
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent orJapanese descent having all four Japanese grandparents born in Japan.

  2. SAD and MAD in Healthy Volunteers: Male or female aged 18 to 55 years; MAD: Male orfemale ≥18 years of age.

  3. ALL COHORTS: Weight of 45 kg to 100 kg and BMI of 18.0 to 30.0 kg/m2.

  4. SAD and MAD in Healthy Volunteers: Non-childbearing, non-breastfeeding females ormales willing to use double barrier contraception or abstention from sex and spermdonation during the study; MAD: Males willing to use double barrier contraception orabstention from sex and sperm donation during the study; non-childbearing females orfemales of childbearing potential using protocol-defined method contraception, andwho is not pregnant, lactating, or breastfeeding.

  5. MAD: Diagnosis of chronic AD.

  6. MAD: EASI score ≥16.

  7. MAD: vIGA-AD™ score of ≥3.

  8. MAD: Atopic lesions cover ≥10% of body surface area (BSA).

  9. MAD: PP-NRS score ≥4.

  10. MAD: Daily use of non-prescription emollient.

Note: Other protocol-defined Inclusion criteria apply.

Exclusion

Exclusion Criteria:

  1. SAD and MAD in Healthy Volunteers: Any clinically-relevant medical history or lababnormality, including positive test for SARS-CoV-2, Hepatitis B or C, or HIV; MAD:Clinically-significant, abnormal laboratory findings, or positive test forSARS-CoV-2, Hepatitis B or C, or HIV.

  2. ALL COHORTS: Clinically important ECG abnormalities or history/evidence thereof.

  3. SAD and MAD in Healthy Volunteers: Use of prescription or non-prescriptionmedications (except occasional use of paracetamol).

  4. MAD: Diagnosis of protocol-specified skin diseases other than AD, or history ofother significant skin condition that could interfere with study assessments.

  5. MAD: History or ongoing allergy/hypersensitivity or history, or history ofhypersensitivity to biological drugs.

  6. MAD: Recent receipt of immunoglobulin or blood products.

  7. MAD: Recent treatment with protocol-specified investigational treatments, or anyprior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or otherprotocol-specified drugs.

  8. MAD: AD with recent ocular involvement requiring chronic ocular corticosteroidtreatment.

  9. MAD: Chronic pruritis due to conditions other than AD.

  10. MAD: Acute AD superinfection, recent superficial skin infection, or otherchronic/acute infection requiring protocol-defined treatments.

  11. MAD: Recent use of sedating antihistimines, systemic corticosteroids, cytotoxictreatments, other immunosuppressive/immunomodulating agents, and otherprotocol-specified prohibited medications.

  12. MAD: Recent topical corticosteroid or prescription moisturizer use.

Note: Other protocol-defined Exclusion criteria apply.

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 10, 2023
Estimated Completion Date:
October 01, 2024

Connect with a study center

  • Alberta DermaSurgery Centre

    Edmonton, Alberta T6G1C3
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G2B7
    Canada

    Site Not Available

  • DermEffects

    London, Ontario N6H5L5
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Québec, G1W4R4
    Canada

    Site Not Available

  • Universitätsklinikum Frankfurt am Main - Klinik für Dermatology

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Universitätsmedizin Mainz

    Mainz, Hessen 55131
    Germany

    Site Not Available

  • Universitätsklinikum Bonn AöR

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • UK-SH - Lübeck

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • COPERNICUS Podmiot Leczniczy Sp. z o.o., Szpital Sw. Wojciecha

    Gdansk, 80-462
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. F.Chopina w Rzeszowie

    Rzeszów, 35-055
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warszawa, 02-953
    Poland

    Site Not Available

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych

    Warszawa, 02-507
    Poland

    Site Not Available

  • First OC Dermatology Research

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center for Dermatology Clinical Research

    Fremont, California 94538
    United States

    Site Not Available

  • California Clinical Trials Medical Group (CCTMG) managed by Parexel

    Glendale, California 91206
    United States

    Site Not Available

  • UCLA Department of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • TCR Medical Corporation

    San Diego, California 92123
    United States

    Site Not Available

  • Annexus Dermatology & Aesthetics

    DeLand, Florida 32720
    United States

    Site Not Available

  • D&H Tamarac Research Center

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Sadick Research Group

    New York, New York 10075
    United States

    Site Not Available

  • Paddington Testing Co.

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

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