EUCTR2020-004703-14-HU进行中（未招募）1 期
A randomized, double-blind, placebo controlled, proof of concept study assessing the efficacy and safety of the RIPK1-inhibitor SAR443122 in patients with moderate to severe subacute or discoid/chronic cutaneous lupus erythematosus - CLEan
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening.
- •-Participants with histologically confirmed and documented diagnosis within one year prior to Screening or during Screening period prior to randomization.
- •-Active cutaneous lupus erythematosus skin lesions and a Cutaneous Erythematosus.
- •-Disease Area and Severity Index activity (CLASI-A) =10 both at Screening and Baseline.
- •-Participant who is candidate for systemic treatment per Investigator’s judgement.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 115
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •-Systemic lupus erythematosus according to the 2012 SLICC criteria with major organ involvement.
- •-Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
- •-Autoimmune disease(s) other than systemic lupus erythematosus.
- •-Active skin diseases that may interfere with the study or study assessments.
- •-Exclusion related to tuberculosis, non-tuberculous mycobacterial infections, HIV, HBV, HCV, Herpes zoster, COVID-19 and other recurrent or recent serious infections.
- •-Prolonged QTcF = 450 ms (by Frederica formulation) or clinically significant findings on electrocardiogram (ECG).
- •-Cannot avoid excessive UV exposure 4 weeks prior to baseline and during the study. Routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study.
- •-Concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit.
- •-Initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to Screening visit (or during Screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine.
- •-Systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication. Systemic corticosteroids treatment <4 weeks before baseline visit.
- •-Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study.
- •-Laboratory abnormalities at the Screening visit.
研究者
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