TerminatedPhase 1

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

Stopped: 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.

United States126 participantsStarted 2023-05-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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).

Exclusion criteria

What they're measuring

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

Timeframe: First dose through end of study (Day 57)

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

Timeframe: First dose through end of study (Day 85)

Trial details

NCT IDNCT05859724

SponsorYellow Jersey Therapeutics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-01

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