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

Numab Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Atopic Dermatitis

Treatments: Biological: NM26-2198; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05859724

NB-NM026-2198-101

2023-503577-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Other: Placebo

NM26-2198

Experimental group

Description:

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

Treatment:

Biological: NM26-2198