CTRI/2022/02/040195尚未招募2 期
Phase 2 open label single arm study to assess the effectiveness and safety of injection secukinumab in congenital ichthyosis
Department of Health Research0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
- •1.Congenital ichthyosis patients - patients with autosomal recessive congenital ichthyosis, Keratinopathic ichthyosis or Netherton syndrome- of age 6 years and older at the time of screening.
- •2.Confirmed diagnosis by next-generation sequencing
- •3.Women of child bearing potential with a negative urine pregnancy test and using adequate contraception.
- •4.Patients who can give valid consent.
- •5.Subjects must be clinically judged to be immunocompetent.
- •6.Subjects with no allergy to secukinumab or components of the product.
- •7.Subjects with normal baseline laboratory testing (CBC, HIV negative, hepatitis B, C negative, chest X ray)
排除标准
- •1.Subjects < 6 years of age
- •2.Subjects who are unable to give informed consent or assent.
- •3.Subjects who have a known allergy to secukinumab.
- •4.Female subjects who are pregnant, considering becoming pregnant, or will breastfeed.
- •5.Subjects with a history of tuberculosis or immunosuppressed state
- •6.Subjects who have prior biologic use targeting IL-17A/IL-17 receptor A or IL-12/IL-23 or who have prior use of TNF-alpha blockers.
- •7.Subjects who have used a systemic retinoid within one month prior to initiation.
- •8.Subjects who have used topical retinoids or keratolytic within one week prior to initiation
研究者
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