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KY1005の中等度から重度のアトピー性皮膚炎に対する反応効果を検証する研究、STREAM-AD試験
基本情報
- NCT ID
- NCT05131477
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 390
- 治験依頼者名
- Kymab Limited
概要
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
対象疾患
EczemaAtopic Dermatitis
介入
Amlitelimab(DRUG)
Placebo(DRUG)
依頼者(Sponsor)
Kymab Limited(INDUSTRY)
サノフィ株式会社(INDUSTRY)