Dataset from A Double-blind (Sponsor Unblinded) Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Repeat Dosing of GSK2646264 in Cutaneous Lupus Erythematosus Patients
收藏NIAID Data Ecosystem2026-05-02 收录
下载链接:
https://doi.org/10.25934/00006736
下载链接
链接失效反馈官方服务:
资源简介:
This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics
and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic
cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by
photoprovocation (PV).
Current study is two group study. In Group A, Patients with fewer than two active lesions
will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that
develop PV lesions at any time during this period, as determined by the local investigative
team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and
either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin
pharmacokinetic (PK) of study drug, for 28 days.
In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by
the investigators will be enrolled into group B and have one lesion treated with 1%
GSK2646264 and 1 lesion with placebo.
A completed patient will be defined as a subject who receives at least 25 days of study drug
and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients
will be followed for 28 days in Group A only or until complete resolution of induced PV
lesions, as determined by the investigator.
创建时间:
2024-11-26



