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An exploratory study on the influence of Nemolizumab on Drug induced Lymphocyte Stimulation Test (DLST) in healthy volunteers and atopic dermatitis patients

An exploratory study on the influence of Nemolizumab on Drug induced Lymphocyte Stimulation Test (DLST) in healthy volunteers and atopic dermatitis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050240222
Enrollment
15
Registered
2024-12-20
Start date
2024-12-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

None listed

Sponsors

Uratsuji Hideya
Lead Sponsor
Maruho Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy adults (1) Those aged 18 to 64 years old at the time of informed consent (regardless of gender) (2) Those who have been explained the contents of this study and have fully understood it and have given written consent to participate in this study Atopic dermatitis patients (1) Those aged 18 years old or older at the time of informed consent (regardless of gender) (2) Patients who have been diagnosed with atopic dermatitis by a dermatologist and currently have symptoms (3) Patients whose symptoms are mild to severe on the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) (Mild: 2, Moderate: 3, Severe: 4) (4) Those who have been explained the contents of this study and have fully understood it and have given written consent to participate in this study

Exclusion criteria

Exclusion criteria: Healthy adults (1) Those aged 65 or older at the time of informed consent (2) Those who have been diagnosed with atopic dermatitis (3) Who have ever used nemolizumab (4) Who have had a serious accident (e.g. fainting) due to blood collection (5) Have used prescription or over-the-counter drugs within 4 weeks of blood collection (topically acting drugs are allowed) (6) Persons with allergy (e.g., atopic dermatitis, food allergy, asthma, allergic rhinitis, drug allergy) in the second degree of kinship (may include mild seasonal allergic rhinitis (hay fever)) (7) Persons with Chronic skin diseases (e.g., hand eczema). (8) Has used any of the following drugs during the designation period. Topically acting drugs may be used. (a): from 90 days prior to blood collection until the day of blood collection(Tralokinumab, Lebrikizumab) (9) Other subjects deemed ineligible for the study by the investigator Atopic dermatitis patients (1)Patients who have ever used nemolizumab products (2)Patients who have had a serious incident (e.g. syncope) due to blood sampling (3)Patients with no symptoms (Clear: 0) or almost no symptoms (Almost clear: 1) in vIGA-AD (4)Patients with drug allergy (5)Persons who have used the drugs listed below during the specified period. However, topically acting drugs may be used. (a): 1 week prior to the day of blood collection to the day of blood collection(Non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, steroids, anti-tumor agents, JAK inhibitors) (b): 30 days prior to blood collection - day of blood collection(Dupilumab) (c): 90 days prior to blood collection - day of blood collection(Tralokinumab, Lebrikizumab) (6) Other subjects deemed ineligible for the study by the investigator

Design outcomes

Primary

MeasureTime frame
DLST positive rate

Contacts

Public ContactHideya Uratsuji

Maruho Co.,Ltd.

ma_clinicalresearch01@mii.maruho.co.jp+81-6-6371-8913

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026