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TerminatedNCT05859724Updated Jul 6, 2026

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

A Phase 1 interventional study of NM26-2198 and Placebo in Atopic Dermatitis, sponsored by Yellow Jersey Therapeutics AG. Terminated at 15 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Yellow Jersey Therapeutics AG · Phase 1, Interventional, and Treatment

Why this study was terminated
Asset acquisition by Johnson \& Johnson. Minimum study objectives necessary to inform safety, tolerability, and dose selection for Phase 2 dose-ranging evaluation of NM26-2198 were achieved, with full completion of all healthy volunteer cohorts.

From the registry’s dates

  • Primary completion was Oct 2024, 2 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 126 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

This is the only study on the registry with Yellow Jersey Therapeutics AG as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent or Japanese 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 or female ≥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 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.
  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 criteria

Exclusion Criteria:

  1. 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.
  2. ALL COHORTS: Clinically important ECG abnormalities or history/evidence thereof.
  3. SAD and MAD in Healthy Volunteers: Use of prescription or non-prescription medications (except occasional use of paracetamol).
  4. MAD: Diagnosis of protocol-specified skin diseases other than AD, or history of other significant skin condition that could interfere with study assessments.
  5. MAD: History or ongoing allergy/hypersensitivity or history, or history of hypersensitivity to biological drugs.
  6. MAD: Recent receipt of immunoglobulin or blood products.
  7. MAD: Recent treatment with protocol-specified investigational treatments, or any prior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or other protocol-specified drugs.
  8. MAD: AD with recent ocular involvement requiring chronic ocular corticosteroid treatment.
  9. MAD: Chronic pruritis due to conditions other than AD.
  10. MAD: Acute AD superinfection, recent superficial skin infection, or other chronic/acute infection requiring protocol-defined treatments.
  11. MAD: Recent use of sedating antihistimines, systemic corticosteroids, cytotoxic treatments, other immunosuppressive/immunomodulating agents, and other protocol-specified prohibited medications.
  12. MAD: Recent topical corticosteroid or prescription moisturizer use.

Note: Other protocol-defined Exclusion criteria apply.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo (for NM26-2198) for subcutaneous (SC) injection in healthy volunteers (HVs) on Day 1 (SAD Cohorts) and on Days 1, 8, 15, and 22 (MAD Cohorts)

    Other: Placebo

  • Experimental
    NM26-2198

    NM26-2198 10mg, 50mg, 150mg, 300mg, 400mg, 600mg, and 900mg for SC injection in HVs on Day 1 (SAD Part A); NM26-2198 150mg and 300mg for SC injection in patients with AD on Days 1, 8, 15, and 22 (MAD Part B); NM26-2198 150mg and 300mg for SC injection in HVs on Days 1, 8, 15, and 22 (MAD Part C)

    Biological: NM26-2198

Interventions

  • BiologicalNM26-2198

    IL-4R/IL-31 bispecific antibody for subcutaneous administration

  • OtherPlacebo

    Placebo for NM26-2198

06

What researchers measure

Primary outcomes

  1. Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD]

    TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit \[Day 57 in SAD\]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.

    Time frame: First dose through end of study (Day 57)

  2. Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]

    TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit \[Day 85 in MAD\]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.

    Time frame: First dose through end of study (Day 85)

Secondary outcomes

  1. Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [SAD]

    Mean maximum concentration of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  2. Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [MAD]

    Mean maximum concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  3. Pharmacokinetics of NM26-2198: Trough Concentration (Ctrough) [MAD]

    Mean trough concentrations of NM26-2198 with multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  4. Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [SAD]

    Mean time of maximum concentration of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  5. Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [MAD]

    Mean time of maximum concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  6. Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [SAD]

    Mean area under the curve from the time of dosing to the last measurable concentration of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  7. Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [MAD]

    Mean area under the curve from the time of dosing to the last measurable concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  8. Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [SAD]

    Mean area under concentration-time curve over dosing interval of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 7

  9. Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [MAD]

    Mean area under concentration-time curve over dosing interval of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 29

  10. Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [SAD]

    Mean estimated total exposure to NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  11. Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [MAD]

    Mean estimated total exposure to NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  12. Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [SAD]

    Mean time-averaged concentration of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  13. Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [MAD]

    Mean time-averaged concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  14. Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [SAD]

    Mean estimated time to last quantificable concentration of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  15. Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [MAD]

    Mean estimated time to last quantificable concentration of NM26-2198 after multiple dose administration in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  16. Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [SAD]

    Mean terminal elimination rate of NM26-2198 after single dose administrations in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  17. Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [MAD]

    Mean terminal elimination rate of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  18. Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [SAD]

    Mean terminal elimination half-life of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Pre-dose on Day 1 through Day 57

  19. Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [MAD]

    Mean terminal elimination half-life of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Pre-dose on Day 1 through Day 85

  20. Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [SAD]

    Mean total body clearance of NM26-2198 after single dose administration in healthy subjects.

    Time frame: Day 1

  21. Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [MAD]

    Mean total body clearance of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Day 1 and Day 22

  22. Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [SAD]

    Mean apparent volume of distribution of NM26-2198 after single dose administrations in healthy subjects.

    Time frame: Day 1

  23. Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [MAD]

    Mean apparent volume of distribution of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Day 1 and Day 22

  24. Pharmacokinetics of NM26-2198: Accumulation ratio of last dose Cmax (Racc,cmax) [MAD]

    Mean accumulation ratio of last dose Cmax of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Day 1 through Day 22

  25. Pharmacokinetics of NM26-2198: Accumulation ratio of last dose AUCtau (Racc,AUCtau) [MAD]

    Mean accumulation ratio of last dose AUCtau of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.

    Time frame: Day 1 through Day 22

  26. Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [SAD]

    Time frame: Pre-dose on Day 1 through Day 57

  27. Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [MAD]

    Time frame: Pre-dose on Day 1 through Day 85

  28. Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [SAD]

    Time frame: Pre-dose on Day 1 through Day 57

  29. Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [MAD]

    Time frame: Pre-dose on Day 1 through Day 85

  30. Mean ADA titers [SAD]

    Time frame: Pre-dose on Day 1 through Day 57

  31. Mean ADA titers [MAD]

    Time frame: Pre-dose on Day 1 through Day 85

07

Study locations

15 sites
  • First OC Dermatology Research
    Fountain Valley, California 92708, United States
  • California Clinical Trials Medical Group (CCTMG) managed by Parexel
    Glendale, California 91206, United States
  • TCR Medical Corporation
    San Diego, California 92123, United States
  • D&H Tamarac Research Center
    Tamarac, Florida 33321, United States
  • Sadick Research Group
    New York, New York 10075, United States
  • Paddington Testing Co.
    Philadelphia, Pennsylvania 19103, United States
  • DermEffects
    London, Ontario N6H5L5, Canada
  • Centre de Recherche Saint-Louis
    Québec, G1W4R4, Canada
  • Universitätsmedizin Mainz
    Mainz, Hesse 55131, Germany
  • Universitätsklinikum Carl Gustav Carus
    Dresden, Saxony 01307, Germany
  • UK-SH - Lübeck
    Lübeck, Schleswig-Holstein 23538, Germany
  • COPERNICUS Podmiot Leczniczy Sp. z o.o., Szpital Sw. Wojciecha
    Gdansk, 80-462, Poland
  • Uniwersytecki Szpital Kliniczny im. F.Chopina w Rzeszowie
    Rzeszów, 35-055, Poland
  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych
    Warsaw, 02-507, Poland
  • Klinika Ambroziak Dermatologia
    Warsaw, 02-953, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05859724
Lead sponsor
Yellow Jersey Therapeutics AG
Responsible party
Sponsor
First posted
May 16, 2023
Start date
May 10, 2023
Primary completion
Oct 1, 2024
Completion
Oct 17, 2024
Last update
Jul 6, 2026

Study contacts

Yellow Jersey Therapeutics AG Clinical trial
study director · Yellow Jersey Therapeutics AG

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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