Phase
Condition
Rosacea
Rash
Hives (Urticaria)
Treatment
Placebo
NM26-2198
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent orJapanese 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 orfemale ≥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 ormales willing to use double barrier contraception or abstention from sex and spermdonation during the study; MAD: Males willing to use double barrier contraception orabstention from sex and sperm donation during the study; non-childbearing females orfemales of childbearing potential using protocol-defined method contraception, andwho 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.
Note: Other protocol-defined Inclusion criteria apply.
Exclusion
Exclusion Criteria:
SAD and MAD in Healthy Volunteers: Any clinically-relevant medical history or lababnormality, including positive test for SARS-CoV-2, Hepatitis B or C, or HIV; MAD:Clinically-significant, abnormal laboratory findings, or positive test forSARS-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-prescriptionmedications (except occasional use of paracetamol).
MAD: Diagnosis of protocol-specified skin diseases other than AD, or history ofother significant skin condition that could interfere with study assessments.
MAD: History or ongoing allergy/hypersensitivity or history, or history ofhypersensitivity to biological drugs.
MAD: Recent receipt of immunoglobulin or blood products.
MAD: Recent treatment with protocol-specified investigational treatments, or anyprior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or otherprotocol-specified drugs.
MAD: AD with recent ocular involvement requiring chronic ocular corticosteroidtreatment.
MAD: Chronic pruritis due to conditions other than AD.
MAD: Acute AD superinfection, recent superficial skin infection, or otherchronic/acute infection requiring protocol-defined treatments.
MAD: Recent use of sedating antihistimines, systemic corticosteroids, cytotoxictreatments, other immunosuppressive/immunomodulating agents, and otherprotocol-specified prohibited medications.
MAD: Recent topical corticosteroid or prescription moisturizer use.
Note: Other protocol-defined Exclusion criteria apply.
Study Design
Connect with a study center
Alberta DermaSurgery Centre
Edmonton, Alberta T6G1C3
CanadaSite Not Available
University of Alberta Hospital
Edmonton, Alberta T6G2B7
CanadaSite Not Available
DermEffects
London, Ontario N6H5L5
CanadaSite Not Available
Centre de Recherche Saint-Louis
Québec, G1W4R4
CanadaSite Not Available
Universitätsklinikum Frankfurt am Main - Klinik für Dermatology
Frankfurt, Hessen 60590
GermanySite Not Available
Universitätsmedizin Mainz
Mainz, Hessen 55131
GermanySite Not Available
Universitätsklinikum Bonn AöR
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen 01307
GermanySite Not Available
UK-SH - Lübeck
Lübeck, Schleswig-Holstein 23538
GermanySite Not Available
COPERNICUS Podmiot Leczniczy Sp. z o.o., Szpital Sw. Wojciecha
Gdansk, 80-462
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. F.Chopina w Rzeszowie
Rzeszów, 35-055
PolandSite Not Available
Klinika Ambroziak Dermatologia
Warszawa, 02-953
PolandSite Not Available
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych
Warszawa, 02-507
PolandSite Not Available
First OC Dermatology Research
Fountain Valley, California 92708
United StatesSite Not Available
Center for Dermatology Clinical Research
Fremont, California 94538
United StatesSite Not Available
California Clinical Trials Medical Group (CCTMG) managed by Parexel
Glendale, California 91206
United StatesSite Not Available
UCLA Department of Medicine
Los Angeles, California 90033
United StatesSite Not Available
TCR Medical Corporation
San Diego, California 92123
United StatesSite Not Available
Annexus Dermatology & Aesthetics
DeLand, Florida 32720
United StatesSite Not Available
D&H Tamarac Research Center
Tamarac, Florida 33321
United StatesSite Not Available
Sadick Research Group
New York, New York 10075
United StatesSite Not Available
Paddington Testing Co.
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
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