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

NCT ID: NCT05859724

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2024-10-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo for NM26-2198

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)

Group Type: EXPERIMENTAL

NM26-2198

Intervention Type: BIOLOGICAL

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

Interventions

NM26-2198

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

Intervention Type: BIOLOGICAL

Placebo

Placebo for NM26-2198

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yellow Jersey Therapeutics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yellow Jersey Therapeutics AG Clinical trial

Role: STUDY_DIRECTOR

Yellow Jersey Therapeutics AG

Locations

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

Countries

United States; Canada; Germany; Poland

Other Identifiers

2023-503577-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NB-NM026-2198-101

Identifier Type: -

Identifier Source: org_study_id