NCT05211830

A Study to Evaluate Topically Applied SXR1096 Cream in Patients With Netherton Syndrome

A Phase I/II, Multicenter, Randomized, Double-blind, Placebo Within-patient Controlled, First-in-human (FIH) Proof of Concept (PoC) Study to Evaluate the Safety and Efficacy of Topically Applied SXR1096 Cream in Patients With Netherton Syndrome (NS)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sixera Pharma · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Netherton Syndrome

Interventions

Type	Name	Description
DRUG	SXR1096 cream	Skin cream to be applied twice a day to a predefined area of the skin
DRUG	Placebo cream	Skin cream to be applied twice a day to a predefined area of the skin

Timeline

• Start date: 2021-12-07
• Primary completion: 2025-06-10
• Completion: 2025-08-20
• First posted: 2022-01-27
• Last updated: 2025-12-16

Locations

5 sites across 4 countries: Austria, France, Germany, Sweden