CTRI/2021/08/035384已完成2 期
A randomized, double-blind, placebo controlled, proofof concept study assessing the efficacy and safety ofthe RIPK1-inhibitor SAR443122 in patients with moderate to severe subacute or discoid/chronic cutaneous lupus erythematosus - CLEan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
- •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 CLASI-A =10 both at Screening and Baseline.
- •Participant who is candidate for systemic treatment per Investigator’s judgement.
- •ll Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •a) Male participants
- •Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 days after the last dose of IMP, corresponding to time needed to eliminate study intervention(s) (eg, 5 terminal half-lives)
- •Refrain from donating sperm
- •PLUS, either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
- •Must agree to use contraception/barrier as detailed below:
- •A male condom and an additional highly effective contraceptive method as described in Appendix 4 Contraceptive and barrier guidance (Section 10.4) when
- •having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
- •b) Female participants
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies
- •Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Contraceptive and barrier guidance (Section 10.4).
- •Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, as described in
- •Appendix 4 Contraceptive and barrier guidance (Section 10.4) during the study intervention period and for at least 2 days, corresponding to the time needed to eliminate any study intervention(s) (eg, 5 terminal half-lives) plus 30 days (a menstrual cycle) after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine and/or serum as required by local regulations) at Screening and Baseline visits before the first administration of study intervention.
- •Pregnancy testing.
- •If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •Local regulations regarding contraception for male and female participants
- •Capable of giving signed informed consent. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative.
排除标准
- •Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
- •Diagnosed with certain subtypes of CCLE (such as Lupus erythematosus tumidus, Chilblain, lupus panniculitis, lichenoid cutaneous lupus/lichen planus overlap syndrome).
- •Autoimmune disease(s) other than systemic lupus erythematosus (eg, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet’s disease etc).
- •Active skin diseases that may interfere with the study or study assessments (eg, Psoriasis).
- •History of any malignancy except history of adequately treated basal cell carcinoma or in situ cervical carcinoma.
- •History of HIV infection or positive HIV serology at screening.
- •History of recurrent or recent serious infection (eg pneumonia, septicemia) within 4 weeks of screening, infection requiring hospitalization or intravenous antibiotics, antivirals or antifungals within 4 weeks of screening or chronic bacterial infections deemed unacceptable, as per Investigator’s judgement.
- •Surgery within 4 weeks prior to the screening visit or with planned surgery during the study.
- •Positive COVID-19 screening test, suspected of COVID-19 infection or known exposure to COVID-19 during the screening period.
- •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.
- •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.
- •Participation in another clinical study 60 days before baseline visit.
- •Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- •Any country-related specific regulation that would prevent the participant from entering the study.
- •Individuals with established dependency on drugs or alcohol, per the judgement of the investigator.
- •Any specific situation during study implementation/course that may rise ethics considerations.
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
研究者
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