A first-in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome (CBPR277X2101) - CBPR277X2101

ovartis Pharma BV0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•Male and female patients with Netherton syndrome, 18 to 65 years of age inclusive.
•Confirmed diagnosis of Netherton syndrome (SPINK5 mutation and/or LEKTI deficiency in the skin).
•Total lesional sign score NS (TLSS-NS) of 5-9 for each selected treatment area at baseline.
•Each treatment area must have a minimum of approximately 250 cm2 of lesional skin within a maximum of approximately 1500 cm2. The TLSS-NS values of both treatment areas need to be similar and, if possible, should not differ (±) by more than 1 point between the two areas at baseline.

•History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
•Pregnant or nursing (lactating) women.
•Women of child-bearing potential not using acceptable contraceptive methods.
•Recent previous treatment with phototherapy, biological therapy, immunosuppressive agents (see protocol page 62 for details).

发起方

ovartis Pharma BV