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Clinical Trial Summary

In this phase I/II trial a topical skin cream with the active substance SXR1096 will be tested in patients with Netherton syndroms, a rare inflammatory skin disease. SXR1096 is a specific and potent protease inhibitor that can inhibit the proteases kallikrein 5, 7 and 14 - all recognised as up-regulated and causing the disease state in Netherton syndrome patients. Patients will be treated for one month with active cream and placebo cream at different areas of the skin.


Clinical Trial Description

Netherton syndrome is a ultra-rare and very severe form of ichtyosis. It is a mongenetic disease. There is no specific treatment available for Netherton syndrome. In this phase I/II trial a topical skin cream with the active substance SXR1096 will be tested in patients with Netherton syndrom. SXR1096 is a specific and potent protease inhibitor that can inhibit the proteases kallikrein 5, 7 and 14 - all recognised as up-regulated and causing the disease state in Netherton syndrome patients, as these patients have a gene defect in the gene spink5 encoding for the protease inhibitor LEKTI - that will normally regulate the activity of KLK5, 7 and 14 in the stratum corneum of the skin, Patients will be treated for one month with active cream and placebo cream at different areas of the skin. The study will assess the safety and efficacy of the treatment in patients. There will also be pharmacokinetic, pharmacodynamic and biomarker studies conducted. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05211830
Study type Interventional
Source Sixera Pharma
Contact Hans Olivecrona, MD PhD
Phone +46706629262
Email study@sixerapharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 7, 2021
Completion date December 20, 2022

See also
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Completed NCT01428297 - A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome Phase 1
Recruiting NCT05521438 - Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome Phase 2/Phase 3
Recruiting NCT05388903 - A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects Phase 1
Recruiting NCT04244006 - A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome Phase 2/Phase 3
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Completed NCT02113904 - Clinical Trial Using Humira in Netherton Syndrome Phase 2
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Recruiting NCT02081313 - Natural History and Biological Study of Netherton Syndrome N/A
Recruiting NCT01545323 - Gene Therapy for Netherton Syndrome Phase 1