A Study to Evaluate Topically Applied SXR1096 Cream in Patients With Netherton Syndrome (NCT05211830) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate Topically Applied SXR1096 Cream in Patients With Netherton Syndrome
Austria, France, Germany9 participantsStarted 2021-12-07
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged 18 to 65 years at the screening visit and also adolescents (12-17 years) only after initial cohort of 5 adult patients have been treated for at least three days.
✓. Patients/legal guardian endpoint must be willing to provide written informed consent.
✓. Clinical diagnosis of NS including at least 3 out of the 4 following clinical criteria;
✓. Neonatal erythroderma
✓. Bamboo hair and/or alopecia
✓. Chronic atopy specified as food allergy, asthma, rhino conjunctivitis and/or eczema for at least 2 years
✓. Ichthyosis linearis circumflexa
✓. Patients must be willing and able to understand and can comply with study requirements, apply the medication as instructed and be able to complete the study.
Exclusion criteria
✕. Female patient who is pregnant, nursing an infant or planning a pregnancy throughout the course of the study
✕. Patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabile for at least 3 months will not be considered for entry into the study.
✕. Patient with positive serology tests like HIV, HCV \& HBsAg.
✕. Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications. Cutaneous infection within 1 week before the baseline visit or, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
What they're measuring
1
Safety of the treatment with SXR1096 compared to placebo in initial cohort of adults
Timeframe: 4 week
2
Safety of the treatment with SXR1096 compared to placebo in adults and adolescents
Timeframe: 4 weeks
3
Efficacy of the treatment with SXR1096 compared to placebo in adults and adolescents
✕. Patient that has a condition or is in a situation, which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
✕. Use of topical drugs that might alter the course of NS (e.g., topical corticosteroids and topical calcineurin inhibitors) within two weeks before baseline visit.
✕. Patient with a known sensitivity to any of the study treatments and/or their components.
✕. Patient who anticipates a need to use other topical or systemic therapy that might alter the course of NS. Emollients/creams can be used on remaining skin area but not the test areas. Use of topical prescription treatment within 2 weeks prior to initial dosing of study drug. Recent systemic treatment for NS (e.g. systemic corticosteroids, antibiotics, immunosuppressant, biologic and biosimilars treatments). A washout period of 4 weeks will be required for such patients to be eligible to participate in the trial.