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

NCT05859724 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: NB-NM026-2198-1012023-503577-38
• Study Type: interventional
• Target: 126
• Locations: 4 countries
• Sites: 15

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 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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.

  First dose through end of study (Day 57)

• 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.

  First dose through end of study (Day 85)

Secondary Outcomes (31)

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

  Pre-dose on Day 1 through Day 57

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

  Pre-dose on Day 1 through Day 85

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

  Pre-dose on Day 1 through Day 85

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

  Pre-dose on Day 1 through Day 57

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

  Pre-dose on Day 1 through Day 85

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

NM26-2198

EXPERIMENTAL

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

NM26-2198 BIOLOGICAL

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

NM26-2198

Placebo OTHER

Placebo for NM26-2198

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Yellow Jersey Therapeutics AG: lead

Study Sites (15)

First OC Dermatology Research

Fountain Valley, California, 92708, United States

Location

California Clinical Trials Medical Group (CCTMG) managed by Parexel

Glendale, California, 91206, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Paddington Testing Co.

Philadelphia, Pennsylvania, 19103, United States

Location

DermEffects

London, Ontario, N6H5L5, Canada

Location

Centre de Recherche Saint-Louis

Québec, G1W4R4, Canada

Location

Universitätsmedizin Mainz

Mainz, Hesse, 55131, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

UK-SH - Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

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

Gdansk, 80-462, Poland

Location

Uniwersytecki Szpital Kliniczny im. F.Chopina w Rzeszowie

Rzeszów, 35-055, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych

Warsaw, 02-507, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yellow Jersey Therapeutics AG Clinical trial

  Yellow Jersey Therapeutics AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: May 10, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 17, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); US (6); CA (2); DE (3)