臨床研究等提出・公開システム

プラセボ対照二重盲検

Double-Blind, Placebo-Controlled

Part1:
-同意取得時に20 歳以上45 歳未満の日本人又は白人男性
-事前検査時にBMI が18.5 以上30.0 未満の者
Part2:
-同意取得時に18 歳以上の男女
-事前検査にて、EASI が12 以上である患者
-事前検査にて、IGA が「3：中度」以上である患者
-事前検査にて、BSA が10%以上である患者

Part 1:
-Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
-BMI >= 18.5 to < 30.0 at time of screening tests
Part 2:
-Men and women aged 18 years or older at the time of consent
-Patients with EASI >= 16 in pre-administration testing
-Patients with IGA of "3: Moderate" or higher in pre-administration testing
-Patients with BSA >= 10% at screening in pre-administration testing

Part 1:
-呼吸器疾患、心疾患、消化器疾患、腎疾患又は肝臓疾患の現病を有する者
-同意取得前 28 日以内に、細菌、ウイルス、真菌又は寄生虫感染症が認められた者
-同意取得前 6 ヵ月以内に入院又は抗生物質の IV 投与を必要とする感染症に罹患した者
-同意取得前 6 ヵ月以内に、生物学的製剤（抗体等）の治療又は治験薬の投与を受けた者
-同意取得前 2 週（免疫抑制剤は 60 日間）以内に薬剤（一般用医薬品、外用剤、ビタミン剤及び漢方薬を含む）を使用した者
-日常の喫煙本数が平均 10 本／日を超える者（事前検査時の問診で確認）又は治験期間中の喫煙に関する規定に従うことができない者
Part 2:
治験責任医師又は治験分担医師により試験の実施及び評価に影響を及ぼすと判断され
た重大な合併症を有する患者。次のものを含むがそれらに限定しない。高度な心血管疾患（e.g. New York Heart Association 機能分類でclass III 又はIV）、コントロール不良な糖尿病（HbA1c 8.5%超）、コントロール不良な高血圧、中等症以上の肝疾患（e.g.Child-Pugh 分類でclass B 又はC）、腎疾患、呼吸器疾患、消化器疾患、血液疾患、中枢神経系疾患、精神疾患、自己免疫疾患等
-事前検査にて下記のいずれかの臨床検査値異常が認められる患者
好中球数：1500/uL 未満
血清クレアチニン：1.5 mg/dL 超
AST 又はALT：基準値上限の2.5 倍超
その他、治験責任医師又は治験分担医師が、本治験の完了又は評価に影響を及ぼすと考える臨床検査値異常

Part 1:
-Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease
-Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent
-Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent
-Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent
-Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days)
-Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period
Part 2:
-Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c > 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc.
-Patients observed to have one of the following laboratory test abnormalities in screening tests
Neutrophil count: < 1500/uL
Serum creatinine: > 1.5 mg/dL
AST or ALT: > 2.5-fold the upper limit of the reference range
Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial

18歳以上

18age old over

上限なし

No limit

男性・女性

Both

試験中止（恒久的）

terminated