Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Exploratory Clinical Activity of NM26-2198 in Healthy Volunteers and in Adult Patients With Atopic Dermatitis

Keywords

Atopic Dermatitis, Dermatitis, Eczema

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UCLA Department of Medicine not yet accepting patients
    Los Angeles California 90033 United States
  • California Clinical Trials Medical Group (CCTMG) managed by Parexel accepting new patients
    Glendale California 91206 United States
  • First OC Dermatology Research accepting new patients
    Fountain Valley California 92708 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Numab Therapeutics AG
ID
NCT05859724
Phase
Phase 1 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated